Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Dyads in this group will complete Coping-Together, a 6-week, booklet-based, self-directed coping and self-management skills training intervention. This intervention addresses key psychosocial challenges by offering evidence-based practical skills to: (a) manage symptoms, (b) cope with anxiety, (c) collaborate with the health care team, (d) engage in shared decision-making, (e) communicate with partner and family, and/or (f) obtain the community resources needed. A relaxation CD is also included, in addition to a workbook that accompanies the Coping-Together booklet-based intervention. The workbook aims at helping dyads choose a booklet relevant to their cancer-related challenges faced, find coping skills that best meet these challenges, and make a plan to use one of the coping skills successfully.

Coping Together Booklets and Workbook

Dyads will receive Coping-Together support via weekly telephone calls from a lay coach. Sessions will range between 10-15 minutes. The goal of coaching will be to provide information on how to use the workbook and booklets. Although no formal therapy will be provided, the coach will maintain a positive and encouraging attitude when interacting with participants regardless of their adherence to the intervention recommendations. The sessions will start with the coach setting a predetermined agenda based on the section of the workbook to review that week that week. Then, coaches will ask about the use of the booklets over the previous week, and ask participants about any required support or clarification in using the booklets. Sessions conclude with setting a goal related to the workbook, booklets and/or coping technique to focus on over the coming week.

Lay telephone coaching

Six, 45-60 minute weekly telephone-based sessions with a trained Motivational Interviewing Specialist to progress toward goals. Here, dyads are given one-on-one guidance from a HCP Motivational Interviewing Specialist to practice the skills they need. Calls will focus on problem-solving principles and core components of self-management (70), including: (a) identifying dyads' concerns, (b) reviewing management efforts, (c) identifying goals, (d) identifying skills needed to achieve goals, and (e) addressing barriers to applying skills to current situations, including level of self-efficacy. At each meeting, progress, subsequent goals, and corresponding plans will be discussed.

Motivational Interviewing

High-quality cancer care in Canada relies on family caregivers. Since cancer treatment is provided more and more in outpatient clinics, family caregivers now provide most of the support and care patients need when they return home. The problem is that caregivers often do not feel they have the knowledge and skills to fulfill this role, especially as caregivers often confront tasks once performed by health care professionals. As a result, caregivers experience high levels of burden and need more help to handle the demands of their role. Programs that enhance caregivers' knowledge and prepare them for their role can have positive effects on their well-being. However, these programs are not available in routine cancer care. They just take too much time and personnel and are too expensive. This limited access to resources reduces caregivers' ability to cope and affects their quality of life. If the ultimate goal is to integrate these programs in cancer care, cost-effective service delivery models are needed. One approach that rises to this challenge and is effective is the self-directed format. A self-directed format requires less support from clinicians and is available to individuals when it is most convenient to them. The research team recently developed and evaluated the first self-directed coping skills training intervention for cancer caregivers called Coping-Together. Although self-directed interventions offer the scalability needed for public health interventions, up to 60% of caregivers do not improve after receiving this type of intervention. These caregivers require more support. This innovative trial design will help determine whether changing the type and level of support provided can increase the number of caregivers who improve after receiving Coping-Together. This type of innovative trial design is more and more popular, but has never been used to enhance the feasibility, acceptability, and efficacy of caregiver interventions.

BACKGROUND: Despite improvements in detection and treatment, a cancer diagnosis is appraised as a negative event not only by the person diagnosed, but also by their family caregivers. Cancer is the second most common condition in Canada requiring assistance from caregivers, and caregivers are now taking on more than ever complex illness management roles traditionally performed by health care professionals (HCPs). This is in part attributed to the cost containment climate of the current health care system; there is an increased reliance on community-based care to manage the burden of cancer care on formal care settings. Caregivers' support reduces demands on the formal health care system and positively impacts on patients' adjustment. However, caregivers often take on their roles with little formal support. This results in high anxiety and low quality of life (QOL). In recognition of this, numerous interventions have been developed and found to be efficacious in reducing caregivers' anxiety and increasing their QOL. Unfortunately, these interventions are often time- and resource-intensive, making them too costly for integration in routine care. As more sustainable modes of intervention delivery are required, one format that holds promise is to use a self-directed format (i.e., low-intensity intervention). However, previous research by the team has shown that up to 60% of caregivers do not respond to these types of interventions alone and require additional support. An innovative trial design to developing time-varying, adaptive interventions to maximize clinical effectiveness is the Sequential multiple assignment randomized trials (SMARTs). However, despite increasing popularity, SMARTs remain relatively new to intervention researchers.

OBJECTIVES: The goal of this pilot SMART is to inform the planning of a subsequent larger SMART to evaluate an adaptive dyadic coping and self-management skill training intervention that follows a stepped-care model for caregivers of individuals with cancer. The primary objective of this pilot SMART is to examine the (a) feasibility of the trial procedures and of offering different levels and types of support alongside a self-directed coping and self-management skills training intervention and (b) acceptability of the combinations of the intervention according to patients and their caregivers. The secondary objective is to estimate the clinical significance of adapting the type and level of support provided on the primary and secondary outcomes.

METHODOLOGY: Study activities will be coordinated out of St Mary's Research Centre in Montreal. Weekly, at the McGill University Health Centre (MUHC), St. Mary's Hospital Center, and Ottawa Hospital, a research assistant (RA), along with the treating clinician, will screen new patient records and identify those who meet the medical inclusion criteria. At the time of their scheduled appointment, clinicians will introduce the study to eligible patients and obtain permission for a RA to approach them. The RA will then either complete the screening interview with patients and their caregivers on site, or follow up by telephone to complete the interview. Those eligible will be emailed the link to the consent form and baseline (T0) questionnaire. At BC Cancer Agency and Princess Margaret Cancer Care Centre, posters will be displayed and patients/caregivers will be informed of the study by the Patient and Family Counseling Services team and other health care team members. Patients will be invited to self-refer by calling the RA directly using the toll free number provided. Community-based recruitment will include advertising the study through social media. This strategy will be led by the Environics Research Group who recruited participants for a previous CIHR team grant.

Investigators aim to recruit 56 patients with a primary breast, prostate, or colorectal cancer diagnosis in the previous 6 months.

Inclusion criteria are:

* receiving/planning to receive treatment,
* having a caregiver willing to participate
* access to the internet,
* patient or caregiver screening positive for anxiety.

Patient-caregiver dyads returning their consent forms and baseline questionnaires (T0) will be randomized by the study coordinator to either: (a) Coping-Together - a 6-week self-directed, dyadic coping and self-management skills training intervention or (b) Coping-Together plus brief, weekly lay telephone coaching. At the end of 6 weeks, intervention response will be assessed by the RA (T1) based on the change in patients' and caregivers' anxiety (primary tailoring variable). Across both groups, non-responders will then be randomized a second time to either (a) continue with their first stage intervention or (b) begin telephone-based self-management counseling for another 6 weeks (either with a lay coach if self-directed for the first six weeks or with a health professional if coached for the first six weeks). Responders will continue with usual care. All participants will then complete their follow-up questionnaire (T2) to examine changes in anxiety and QOL (primary outcomes), depression, self-management skills, illness appraisal, and coping (secondary outcomes). Acceptability will also be assessed in this questionnaire and further explored during an exit interview with dyads. Feasibility measures will focus on the characteristics of the dyads reached, protocol fidelity, percent of missing data, and recruitment and retention rates.

SIGNIFICANCE: The ability of caregivers to maintain their QOL despite the stressors they face is undermined by limited access to the support needed. This study will develop and evaluate the first adaptive interventions for this population, and address a significant research gap by documenting its acceptability, feasibility, and clinical significance. Despite advocacy for caregiver support, no other Canadian study has examined how potentially cost-effective interventions can be combined to meet caregivers' needs. Collaboration with six cancer centers will accelerate the uptake of findings.

An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer

An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design

Number of consenting dyads per week over the recruitment period, with report on refusal and drop-out rates and reasons.

Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.

Checklists will be used to assess if the interventions are delivered as per protocol

Rate of tool use and participation in the support sessions.

Using a modified satisfaction questionnaire

McGill University

St. Mary's Research Center, Canada

Principal Scientist

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gastrointestinal Agents

TEMPO

Aluminum hydroxide, magnesium hydroxide, simethicone drug combination

Antioxidants

Protective Agents

Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included).

Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures.

Stage 1 interventions (week 1-12): After 12 weeks, response will be determined. At recruitment, at least one member of the dyad must report anxiety symptoms defined as a Hospital Anxiety and Depression Scale (HADS)-Anxiety subscale score \> 6. After Stage 1, for the dyad to be "TEMPO Responder", both members' anxiety scores on the HADS-Anxiety must be \< 6 or decreased by at least 2 points. If both members of the dyad had anxiety symptoms at recruitment, then both must meet a response criterion. As soon as one dyad member does not meet the response criterion, the dyad is "TEMPO non-responder".

Stage 2 interventions (week 14-25): TEMPO responders continue with TEMPO. Non-responders will be re-randomized to: a) more time with TEMPO or b) add non-health care professional guidance (8 x 20-minute telephone calls). Guides' training will include TEMPO review, their role and the manual. Semi-structured exit interview will gather guides' experiences.

Stage 1 interventions (week 1-12): Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices).

Stage 2 interventions (week 14-25): Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures.

Active Monitoring dyads' anxiety

Sylvie Lambert, PhD

Margit Fuchs, PhD

Manon de Raad

Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes.

BACKGROUND : Up to 60% of men with prostate cancer report some level of anxiety, with clinical levels exceeding population norm. Anxiety results from reactions to the diagnosis, treatment side effects, and the multitude of other anxiety-provoking physical and psychosocial challenges (e.g., treatment decision-making) men face daily. These challenges can be successfully mitigated through self-management, defined as one's actions and decisions to confidently manage medical aspects of cancer, cope with emotions, adjust everyday life, and enhance recovery (e.g., via lifestyle changes). Cancer care lags in the implementation of self-management support, mostly because it requires clinicians' engagement, which conflicts with their limited availability, even if self-management is cost-effective. Men then often lack knowledge for effective self-management; cancer challenges often persist, along with the anxiety they provoke. Cancer challenges are not self-managed in a vacuum; family caregivers are often relied on. The impact of caregiving is substantial, but often dismissed, resulting in high caregiver anxiety. TEMPO, a self-directed, dyadic Tailored, wEb-based psychosocial and physical activity self-Management PrOgram, was developed because staff shortages necessitate innovative models to deliver sustainable self-management support, without compromising efficacy. TEMPO is a tool to help address the quadruple aim of healthcare: enhance dyads' and clinicians' experiences and improve health outcomes at low cost. However, in a pilot study, some dyads needed more guidance to use TEMPO. Barriers to use were mostly motivational, which the investigators previously found can be effectively addressed by guidance from non-health care professionals to spare clinical resources.

OBJECTIVES : The goal of this study is to determine the most efficacious and cost-effective way of adapting TEMPO to dyads' needs for guidance. The primary hypotheses are that a) TEMPO dyads will experience lower anxiety than active monitoring dyads, but dyads needing guidance will report lower anxiety post guided TEMPO than if they had continued with TEMPO self-directed; and b) TEMPO will be cost-effective compared to active monitoring; adding guidance will demonstrate cost-effectiveness among those needing it. For the secondary hypotheses, same effects are expected of TEMPO and guidance on the secondary outcomes and between-group differences in anxiety will be higher among caregivers who are mostly females and women.

METHODOLOGY : This study is a Sequential Multiple Assignment Randomized Trial (SMART) with two sequential intervention stages, cost-effectiveness analysis, and exit qualitative interviews. Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). Dyads will initially be randomized to a) TEMPO self-directed or b) active monitoring of anxiety. After 12 weeks, TEMPO dyads still reporting anxiety will be re-randomized to more time with TEMPO or TEMPO plus guidance, and active monitoring dyads will be offered TEMPO. All participating dyads will continue to access usual care (a co-intervention measure is included). Group allocation will not be blinded. Dyads will be blinded to hypotheses to reduce bias. Research assistants (RAs) will not interact with randomized participants until the exit interview. Guides are not therapists; they focus on adherence, using TEMPO to answer dyads' questions. Phone calls start with the guide and dyad setting an agenda. Guides then ask about TEMPO's use since the last call. Guides conclude calls by reviewing dyad's goals until the next call. Stages 1 and 2 are 12 weeks each. Outcomes are assessed prior to randomization (baseline, T0) and at completion of Stage 1 (11 weeks post-randomization, T1) and Stage 2 (22 weeks post-randomization, T2).

Patient inclusion criteria are:

* Received treatment for prostate cancer (excluding active surveillance) within the past two years
* Identified a primary caregiver willing to participate in the study
* One member of the dyad has anxiety symptoms
* Has access to the internet,
* Understands English or French. Eligible caregivers will be those identified by the patient as his primary source of support. Caregivers also need to be able to read English or French.

Dyads exclusion criteria are:

* Either member of the dyad is hospitalized at recruitment

SIGNIFICANCE :This proposal builds on the investigators' innovative work on efficient, evidence-based dyadic self-management interventions that spare clinical resources but remains efficacious. Clinician partners emphasize the value of TEMPO in their letters of support. Twice as many centres are participating in this trial, compared to the pilot. The research team will make cost-effectiveness recommendations with clinical implementation in mind. Importantly, TEMPO has significant generalizability, as the tools and approaches can readily be adapted to other cancer populations (see letter from Stuart Edmond, Canadian Cancer Society). TEMPO is currently being adapted for use among patients with a head and neck cancer and their caregivers for implementation at the Centre Hospitalier de l'Université de Montréal. Several Cancer Agencies are exploring TEMPO's integration in their resource infrastructure. However, a definitive trial on efficacy, cost-effectiveness, and adaptation to meet dyad's needs for guidance is needed. The research team will also contribute to the emerging literature on SMARTs for behavioral interventions.

A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

A SMART Design to Optimize the Delivery of TEMPO - a Tailored, wEb-based Psychosocial and Physical Activity Self-Management PrOgram for Men With Prostate Cancer and Their Caregivers

Patients and caregivers will each complete their own self-administered questionnaire at T0-T2 via Qualtrics, a secure electronic data capture system. HADS-Anxiety has strong reliability and validity to assess anxiety symptoms among dyads, including responsiveness. Our previous studies supported its ability to discriminate between anxiety and depression. To avoid testing effect, the HADS-Anxiety score obtained at eligibility screening will be used as baseline, if completed within 2 weeks of baseline, consistent with the HADS' test-retest reliability. In our SMART Coping-Together pilot, most dyads completed eligibility and baseline questionnaires within 1 week.

We will document TEMPO's key mechanisms of action: Primary appraisal = Perceived Stress Scale; secondary appraisal = PROMIS self-efficacy scale and the Multidimensional Self-Efficacy for Exercise Scale; self-management = Health Education Impact Questionnaire and Godin Leisure-Time Exercise Questionnaire (GLTEQ); coping = Dyadic Coping Inventory; depression = HADS-depression, and quality of life = SF-12. All measures were used in our pilot and have demonstrated psychometric properties. For physical activity, the modified GLTEQ is moderately correlated with pedometer and accelerometer derived activity data. Dyads will log weekly their step count in a Participant Steps Diary using the pedometer provided or their own devices.

Princess Margaret Hospital, Canada

University of Calgary

Sunnybrook Health Sciences Centre

University of British Columbia

Simon Fraser University

Université de Sherbrooke

Memorial University of Newfoundland

Université de Montréal

Centre intégré de santé et de services sociaux (CISSS) de Laval

Associate Professor

Symptoms and General Pathology

Death

Quality of Life

Caregivers read to patients from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks.

Caregivers apply the instruction of the Touch, Caring and Cancer DVD program for patients for recommended 20 minutes at least 3 times per week for 4 weeks.

Caregivers read to the patient from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks

Attention control (reading)

DVD- and manual-based instruction for caregivers and patients in the use of touch and massage techniques as supportive care in cancer, including: preparation for a session, safety precautions related to cancer and its treatments, communication about touch, centering to calm the mind; manual techniques for the head, neck, shoulders, back, feet and hands to promote relaxation; and acupressure for pain, nausea and anxiety.

Touch, Caring and Cancer DVD program

William Collinge, PhD, MPH

RATIONALE: A multimedia education program for family caregivers that teaches simple methods of touch and massage for the comfort of cancer patients at home may be effective in lowering stress, reducing symptoms, and improving quality of life for patients; and may improve caregiver satisfaction and self-efficacy.

PURPOSE: This randomized phase II trial is studying how well multimedia instruction of caregivers in use of touch and massage works for cancer patients and their care partners.

OBJECTIVES:

Primary

* Produce a multimedia program to deliver instructional content in massage for cancer patients and their lay care partners.
* Determine the effects of the multimedia program on care partner esteem and stress and on the frequency and duration of the care partner's provision of their assigned form of support to the patient.
* Determine the effects of the multimedia program on patient symptom levels, functional quality of life, perceived stress, and physiologic indices of stress.

Secondary

* Examine the impact of the multimedia program on care partner concerns about use of touch as a form of support, and on self-efficacy in massage.

OUTLINE:

* Multimedia program production and screening (year 1): Patient/care partner dyads representative of a broad spectrum of relationships participate in filming a multimedia program about massage, acupressure, light touch, and massage safety precautions. The multimedia program is titled, "Massage for People with Cancer: Simple Instruction for Family and Friends." The program comprises a menu-driven DVD which allows the viewer to select English or Spanish as well as individual chapters of content, and a manual keyed to the DVD content. A different set of diverse patient/care partner dyads screen and critique the multimedia program.
* Randomized controlled study of program's efficacy (year 2): Patient/care partner dyads who reside in the same home are recruited. Dyads within each race/ethnic group are stratified by patient total scores on the baseline FACT-G assessment. Dyads are then randomized to 1 of 2 arms.

  * Arm I (experimental intervention): Dyads attend an orientation meeting with other dyads of their language group in order to meet the Oncology Massage Therapist (OMT) and research assistant (RA) assigned to them during the study; watch the DVD together and discuss it afterward; receive instructions for weekly data collection; and receive explanation about the safety monitoring home visit and the bi-weekly phone monitoring. Instructions for data collection include instructions for the care partner to fill out a sample of the weekly Study Report card. Dyads are given the DVD and manual to take home, and those who do not have a DVD player are provided one. Dyads complete at least one massage over at least 20 minutes once a week for 20 weeks in which they provide the techniques demonstrated in the film. An OMT makes a home visit to each dyad during the first 2 weeks, and then as needed, to monitor for understanding of and adherence to the relevant safety precautions for the given patient. Dyads receive bi-weekly telephone monitoring from an RA in order to encourage compliance with the weekly activity and monitor for any adverse events or safety concerns that warrant another home visit by the dyad's OMT (e.g., changes in medical treatment that call for changes in precautions).
  * Arm II (control intervention): For 4 weeks, care partners spend at least 20 minutes a week alone with the patient, reading to the patient from literature of interest to the patient. The literature may be fiction, non-fiction, or poetry that does not contain news or stressful subject matter. Dyads receive telephone monitoring from their RA within the first week and then every 2 weeks thereafter to encourage compliance, monitor for any adverse events or concerns, and respond to questions about the project. At the end of the 4 weeks, dyads attend an orientation meeting with the Principal Investigator, OMTs, and RAs. At this meeting, dyads view the multimedia program and discuss precautions and any other issues that may affect their utilization of the instruction. Dyads are then given the multimedia program to take home, and a DVD player if they need one. A home visit by an OMT is scheduled to assure the dyad understands and implements relevant safety precautions. The dyads then participate in the use of the intervention for the remaining 16 weeks of the study.

All participants in the study complete quality of life, perceived stress, and other questionnaires at baseline and then at 4, 12, and 20 weeks. Demographic and patient medical information is also collected. Saliva samples are collected from patients at baseline and then at 4, 12, and 20 weeks to monitor cortisol and DHEA levels.

Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care

Couples and Cancer: Building Partner Efficacy in Caring

National Cancer Institute (NCI)

Collinge and Associates, Inc.

President

This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention.

This group will get weekly calls for 16 weeks and two follow-up assessments. Participants will be asked to rate their symptoms on a 0-10 scale at each call. This group will receive the SMSH, a printed evidence-based self-care management handbook with specific modules, that will be directed to use for symptoms rated 4 or higher on a 0-10 scale. For symptoms ≥7, participants will be asked to report the symptom to their provider. At each weekly call, participants will be asked: if they tried symptom self-management strategies and, if yes, which strategies were used. These calls will take 10-15 minutes. If during 8 weeks of SMSH, either the survivor or caregiver have distress (symptoms 4 or greater on a 0-10 scale) for any two consecutive weeks during weeks 2-8, TIP-C will be added for the dyad for 8 weeks. The addition of TIP-C can start between weeks 4 and 9. Dyads will continue the SMSH in addition to the TIPC. TIP-C calls will take 35-45 minutes.

Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)

The attention control arm will receive an NCI brochure: Facing Forward: Life After Cancer Treatment. This group will also get weekly calls for 16 weeks and complete two exit interviews. The NCI brochure will not be address, the purpose of these calls will only be to record participant's symptoms throughout the study. These calls will take about 10 minutes or less.

NCI Brochure

Alexis Alvarez

UACC IIT

Chris Segrin, Ph.D.

As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research.

To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).

This randomized control trial will be composed of at least 106 survivors that are ending their treatment or within 2 years of having completed cancer treatment with curative intent and their informal caregivers. This study will include participants of diverse backgrounds (40% Latinx) from urban and rural (approximately 50% each) areas. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) or 2) Attention control. The participants will receive weekly phone calls during 16 weeks where the interventionist will utilize the General Symptom Management Scale (GSDS) to assess their symptoms and level of symptom distress. After the initial 8 weeks in the Handbook group, the survivor's and caregiver's symptom distress will be assessed. If either the survivor or caregiver indicate elevated psychological distress for any two consecutive weeks during weeks 2 through 8, there will be an addition of TIP-C to their Handbook intervention from weeks 8 through 16. The participants in the attention control group will receive a National Cancer Institute brochure: Facing Forward: Life After Cancer Treatment plus, 16 weekly calls to assess their symptoms. Regardless of randomization, all participants will complete a baseline call and two exit interviews at weeks 17 and 24.

The specific aims are to:

1. Determine if the adaptive need-based SMSH+TIP-C sequence results in improved outcomes compared to the attention control.

   Hypothesis 1a. SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more appropriately scheduled and less unscheduled health services use (secondary outcomes) over weeks 1-24 for survivors and caregivers.

   Hypothesis 1b. Improvements in primary and secondary outcomes will be partially mediated by 1) greater enactment of SMSH strategies in weeks 1-16 and 2) improved perceptions of social support and social isolation by week 17 for survivor and caregivers.
2. Test longitudinal (weeks 1-24) dyadic interdependence in primary and secondary outcomes of survivors and caregivers to determine if there are reciprocating effects between dyad members.
3. Explore if rural versus urban residence and associated Social Determinant of Health factors (e.g., ethnicity, socio-economic status \[SES\], age, insurance) moderate the effects of the SMSH+TIP-C intervention on primary and secondary outcomes and modify the strength of dyadic interdependence in these outcomes for survivors and caregivers.

The interventions will be delivered in English or Spanish, depending on the language preference of the participant.

Symptom Management for Rural-Urban Cancer Survivors and Caregivers

Need-based Adaptive Symptom Management to Address Social Determinants of Health at Individual, Interpersonal, and Community Levels

Participant data will be shared with Dr. Alla Sikorski as she is the statistician for our research team. Dr. Sikorski will perform quality assurance checks, data analysis, data management, etc. De-identified data will be transferred into SAS 9.4 for such analysis.

Symptoms will be measured using the General Symptom Distress Scale (GSDS), which is an instrument that allows a quick assessment of symptoms. It evaluates 15 symptoms such as: depression, anxiety, pain, shortness of breath, nausea, vomiting, diarrhea, constipation, fatigue, cough, poor appetite, sleep difficulties, swelling in hands and feet, difficulty concentrating, and headaches. Participants indicate the presence of each symptom and rate their severity on a scale of 0-10; 0= not experiencing this symptom, 1=mildly distressing to 10=extremely distressing.

To obtain more detail and precision in the measurement of depressive and anxiety symptoms, the PROMIS-short forms 8: depression and anxiety will be administered

Unscheduled and scheduled health visits such as: hospitalizations, urgent care and ER visits and health maintenance and survivorship health service use will be measured. Each participant will be asked to recall scheduled and unscheduled visits, their reasons, duration and where the services were received. We will ask about all preventative health services. For each service, a rating using 3 categories (recommended service was performed, not performed or partially performed, or not recommended and performed) will be made based on the current guidelines.

We will measure health care utilization consistent with clinical practice guidelines for patients in the 24 months after completion of cancer treatment. For example, colon cancer survivors should have a physical exam visit every three to six months, a colonoscopy one year after surgery, a computed tomography (CT) scan (if recommended), and at least four CEA tests. Our 3-category rating for use of each guideline will capture the important distinctions for different services. Extensive previous research documents self-report is a reliable and valid method to collect health services use data especially when standardized methods are used and the recall period is short (over 12 months), as in this project. Self-report is the only reasonable and cost-effective way to assess healthcare use, as it would be impossible to access health records across the multiple systems and payers.

American Cancer Society, Inc.

University of Arizona

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook is available in English and Spanish. Each weekly call will begin with the symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors will be referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms will be assessed. During weekly calls to caregivers, the caregivers will be notified of symptoms above threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms are assessed, a summary of survivors' symptoms provided. Calls will last about 10 minutes.

Each survivor and caregiver will receive one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol is the same for both survivor and caregiver. During weekly contacts, the counselors target social support behaviors using interpersonal communications techniques. Counselors can personalize the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks will be Handbook only.

Handbook

TIP-C plus Handbook

Terry Badger, PhD

Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.

Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors (defined as individuals from diagnosis to end-of-life) in the United States, often with negative consequences to their health. Caregivers assist with the management of the survivor's symptoms such as fatigue, pain and insomnia, and others.Psychological distress (depression and anxiety) has been reported in at least 30% of survivors and their caregivers who are not always prepared for the task of symptom management. This research assists both the caregiver and survivor (the dyad in this study) to manage the survivor's cancer- and treatment-related symptoms and the distress of both members of the dyad in a sample of 298 survivors with elevated depression or anxiety and their 298 caregivers. Dyads will be recruited during the survivor's chemotherapy or targeted therapy for a solid tumor, a time when symptom burden and psychological distress are particularly high.

The investigators will use two evidence-based interventions extensively tested against active and passive controls in traditional randomized controlled trials (RCTs). While overall efficacy of these interventions has been established, individuals differ in their responses. When an intervention does not initially work, clinical logic is to either extend the timeframe or prescribe a different intervention. Yet, these alternatives are seldom tested and not evidence-based. The proposed project advances beyond a traditional RCT of testing fixed "one size fits all" interventions to the sequential multiple assignment randomized trial (SMART) design to build the evidence base for intervention sequencing that accounts for heterogeneity of responses.

The first intervention, a printed symptom management and survivorship handbook (Handbook) with strategies for self-management of symptoms common during chemotherapy will be given to both survivor and caregiver (the dyad). Handbook strategies, if successfully enacted, produce positive symptom responses for the survivor. However, psychological distress of the survivor or the caregiver may diminish the receipt and enactment of the Handbook strategies and also exacerbate the severity of other symptoms which, in turn, produces poor symptom responses. Research by this team has documented dyadic effects where survivors' psychosocial distress impacts that of the caregiver and vice versa. The survivor's and caregiver's distress exhibit similar trajectories. Therefore, the second intervention tested in sequencing is the 8-week telephone interpersonal counseling intervention (TIP-C) to manage psychological distress of the dyad.

The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.

The following specific aims will be tested.

1. Determine if dyads in the TIP-C+Handbook as compared to the Handbook alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department \[ED\] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators).
2. Among non-responders to the Handbook alone after 4 weeks, determine if dyads in TIP-C+Handbook as compared to the Handbook alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17.
3. Test the interdependence in survivors' and caregivers' primary and secondary outcomes.
4. Determine which characteristics of the dyad are associated with responses to the Handbook alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions in the future.

This project will determine which dyads require which intervention sequence: Handbook alone, Handbook alone stepped up with Telephone Interpersonal Counseling (TIP-C) based on demonstrated needs after giving Handbook alone 4 weeks of time, or an combined TIP-C+Handbook for the first 8 weeks then Handbook alone for 4 weeks. Dyads will be initially randomized to either Handbook alone or TIP-C+Handbook. If the survivor's depression or anxiety does not respond to Handbook alone at week 4, dyads will be re-randomized to the TIPC+Handbook or continue with Handbook alone. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Total duration is 17 weeks.

Follow-up data collectors will be blind to the arm of the study.

Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management

Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use

The investigators will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health.

Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. The investigators will select "open access" options for these manuscripts whenever possible.

Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.

Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.

Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 5-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.

Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).

Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely symptomatic.

Adverse events/serious adverse events were identified during the implementation of the experimental protocols and were monitored by the Investigators in several ways: 1) Interviewers could identify both serious adverse events and/or adverse events during the completion of telephone interviews or telephone calls to schedule telephone interviews; 2) The interventionists could identify both serious adverse events and/or adverse events during their telephone contacts with the participants.

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.

Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Week 5-12

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.

Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12

The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.

Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.

Survivors SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12

Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued

Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12

Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12

Caregivers SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.

Survivor Drop-outs From SMSH Alone Prior to Week 4

Caregiver Drop-outs From SMSH Alone Prior to Week 4

Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Weeks 5-12

Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued w/ SMSH Alone Weeks 5-12

Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12

Caregivers- SMSH+ TIPC

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Symptoms were measured using the General Symptom Distress Scale (GSDS) assessment of 18 symptoms: fatigue, sleep difficulty, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicated the severity of each symptom (0= not present, 10= worst possible). A summed symptom severity index for 16 symptoms other than depression and anxiety was derived. The potential range is 0-160, a higher score reflects a worse outcome.

Symptom Severity

The larger than planned number of survivor-caregiver dyads with survivors responding to SMSH alone resulted in larger than planned number of participants in the first randomization and smaller number in the second randomization. There was a larger than planned number of responders to SMSH alone after 4 weeks.

The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.

Average over weeks 1-13

Week 17

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.

Handbook: see arm/group descriptions

Survivors- SMSH Alone

Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.

TIP-C plus Handbook: see arm/group descriptions

Survivors- SMSH+ TIPC

The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.

Caregivers- SMSH Alone

Out of 374 dyads (survivors and caregivers), 277 were randomized initially to the SMSH alone, and 97 to SMSH+TIPC.

Symptom Severity Index- Comparison of Two Groups Created by First Randomization

The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.

The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.

Average over weeks 5-13

Survivors and caregivers randomized for the second time after survivor's non-response to the SMSH alone after 4 weeks.

Symptom Severity Index- Comparison of Two Groups Created by Second Randomization

The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.

The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.

Week 13

Survivors and caregivers included in the first randomization

Depressive Symptoms- Comparison of Two Groups Created by First Randomization

Depressive Symptoms- Comparison of Two Groups Created by Second Randomization

Anxiety Symptoms- Comparison of Two Groups Created by First Randomization

Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization

Overall Study

Blood and Lymph Conditions

Rare Diseases

Leukemia

Hematologic Neoplasms

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Acute Graft Versus Host Disease

Psychotropic Drugs

Patients assigned to the intervention arm will receive 8 - 12 psychotherapy sessions lasting 30 - 60 minutes each, delivered by a trained therapist at our center. Patients will receive specialized symptom control from a nurse/physician team in our Palliative Care Service, when indicated by routine symptom screening.

EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

EASE

Gary Rodin, MD FRCPC

Camilla Zimmermann, MD PhD FRCPC

The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.

This study involves the pilot-testing of a newly developed, brief manualized individual psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom burden in patients with acute leukemia. Usual care for individuals with acute leukemia treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and primarily instrumental, psychosocial care and palliative care service as needed.

The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month of diagnosis and/or admission to hospital for treatment with curative intent.

Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia

A 30-item reliable and valid self-report measure of traumatic stress symptoms.

A 40-item reliable and valid self-report measure of overall quality of life, including 12 items that assess spiritual well-being, spiritual meaning and peace, and faith.

A 21-item reliable and valid self-report measure of the intensity of depressive symptoms, consistent with the DSM-V criteria for major depressive disorder.

A 9-item reliable and valid self-report measure that assesses pain severity and the impact of pain on daily functioning.

A 32-item reliable and valid self-report inventory assessing the presence and severity of 26 common physical symptoms and 6 psychological symptoms of cancer. The scale has been adapted to reduce burden. A shortened version that omits frequency of symptoms and treatment, and satisfaction with treatment for each symptom was used.

A 16-item reliable and valid self-report measure of attachment security.

A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.

A 7-item measure developed for this study to evaluate the extent to which patients felt emotionally supported by the clinical services provided.

A 14-item symptom severity assessment measure adapted for patients with acute leukemia to include prevalent and treatable symptoms in this population: mouth sores, diarrhea, itching, constipation, and insomnia. ESAS-AL was used as a screening tool as part of the clinical intervention, and was added as an outcome later in the trial (13-Apr-2016).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Adaptive Dyadic Self-directed Coping and Self-management Skills Training Intervention for Caregivers of Individuals With Cancer	NCT04255030	Cancer Anxiety	Coping Together... Lay telephone c... Motivational In...	18 Years -	St. Mary's Research Center, Canada
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers	NCT06363266	Cancer of the P... Anxiety	TEMPO Active Monitori...	18 Years -	St. Mary's Research Center, Canada
Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care	NCT00632398	Cancer	Attention contr... Touch, Caring a...	21 Years - 120 Years	Collinge and Associates, Inc.
Symptom Management for Rural-Urban Cancer Survivors and Caregivers	NCT05360498	Cancer Cancer Survivor... Informal Caregi... Psychological D...	Adaptive Sympto... NCI Brochure	18 Years -	University of Arizona
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management	NCT03743415	Cancer	Handbook TIP-C plus Hand...	18 Years -	University of Arizona
Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia	NCT02353559	Acute Leukemia	EASE	18 Years -	University Health Network, Toronto
Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors	NCT00249015	Breast Cancer	Physical exerci...	18 Years -	AHS Cancer Control Alberta
Symptom Management for Rural-Urban Cancer Survivors and Caregivers	NCT05360498	Cancer Cancer Survivor... Informal Caregi... Psychological D...	Adaptive Sympto... NCI Brochure	18 Years -	University of Arizona
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management	NCT03743415	Cancer	Handbook TIP-C plus Hand...	18 Years -	University of Arizona
Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care	NCT00632398	Cancer	Attention contr... Touch, Caring a...	21 Years - 120 Years	Collinge and Associates, Inc.
At-home Breast Oncology Care Delivered With E-health Solutions	NCT05989477	Patient Engagem... Patient Activat... Patient Reporte...	At-home Breast ...	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for psychosocial oncology