Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

Participants will receive 7 weekly group therapy sessions consisting of psychoeducation on fear of cancer recurrence, relaxation training, CBT, and evidenced-based tips to decrease avoidance and anxiety surrounding fear of cancer recurrence.

Participants assigned to this arm wait about 3-months to receive the intervention.

7 weekly sessions of 90-120 minutes each. During the 7 weeks, participants will be asked to participate in activities, participate in group discussions, and complete homework assignments.

Family Caregiver - Fear Of Recurrence Therapy (FC-FORT)

Sophie Lebel, PhD

Fear of cancer recurrence (FCR) is common, persistent, and is associated with negative outcomes. Studies show that family caregivers (FC) of cancer patients experience equal or greater levels of FCR than patients themselves. In the past 5 years, several interventions have demonstrated their ability to reduce FCR among cancer patients, including a group intervention called Fear of Recurrence Therapy (FORT). However, none have ever been adapted and offered to caregivers. The goals of the proposed study are to demonstrate 1) that a newly adapted intervention of FORT (FC-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., FC satisfaction of the intervention) for a larger study, and 2) the clinical implications of FC- FORT on FCR and quality of life. An advisory board composed of researchers, therapists, and FC was created to adapt FORT for FC and to an online format. FC and therapists are currently being recruited to conduct a usability study of the newly adapted FC-FORT. They will be asked to complete a session feedback questionnaire after each session and to take part in an exit interview. The content of these will be summarized back to the advisory board in order to further refine FC-FORT. Following a successful usability study, FC-FORT will be given to four groups of nine new FC (pilot study). Participants will be recruited directly by clinicians and by outreach mailout efforts. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. The proposed study is needed to determine if an already developed FCR intervention can be adapted to family caregivers and if it can be successfully pilot tested. This will help bridge an important gap in bringing evidence-based care to caregivers who have never been offered help before for their FCR. The proposed project will also allow to further feasibility and acceptability of E-Health interventions.

Usability Study

6-8 female family caregivers will be recruited to conduct a usability study of this first version of FC-FORT. Participants will be recruited through the University of Ottawa, the Princess Margaret Cancer Centre, community partners and social media. Two therapists with extensive experience with online support groups to conduct the sessions will be recruited to conduct the groups. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. These therapists will receive an online training from the principal investigators before starting the usability study. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. All eligible participants will attend a one-on-one pre-therapy meeting to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. After each of the seven sessions, the therapists and the participants will be asked to complete a short session feedback questionnaire, via Qualtrics, to assess the usefulness, usability, desirability, value, accessibility, and credibility of the session, as well as about participants' impressions of the online format and features, and the general readiness of the session for end users. Brief videoconference or telephone exit interviews will be conducted post-intervention with both the participating family caregivers and the therapists. The content of these interviews and questionnaires will be summarized and present it back to the project's advisory board in order to further refine the FC-FORT content and format.

Pilot Study

36 family caregivers will be recruited to participate in the study. Additionally, 3 therapists with extensive online support group experience to conduct the FC-FORT videoconference therapy sessions. Therapist competency to administer FC-FORT will be determined by registered professionals in counselling or psychotherapy, at least 5 years of experience in psychosocial oncology, and having led at least one group. Interested family caregivers will contact the research coordinator, via telephone or email, to be screened for eligibility and to complete the consent forms. This pilot study will serve as a first step in potential sample size calculations and recruitment times. For this pilot study, active recruitment will last for a period of 15 months during which 36 FC are aimed to be recruited in order to create 4 groups of 9 participants (2 intervention conditions and 2 WLCG). Feasibility of recruitement for the larger RCT will be determined using these critera: 1) If during our recruitment period less than 18 participants, recruitement for a larger RCT, using our current recruitment strategies, will be deemed not feasible, 2) If between 18 and 25 participants are recruited, then a larger multicentre approach for recruitment will be considered, 3) If recruit 25 participants or more, recruitement for a larger RCT, using our current methods, will be deemed feasible. The sample size will be reevaluated for the larger RCT based on the results from this pilot study.

FC-FORT consists of 7 consecutive weekly group sessions of 90-120 minutes each offered through videoconference and weekly assigned homework. FC-FORT is therapist led, however participants will receive a workbook where they can follow along, take notes, and complete the exercises and the homework assignments. The overall aim of FC-FORT is to guide FC towards a more manageable level of worry and fear of recurrence. The key goals are to: 1) distinguish worrisome symptoms from benign ones; 2) identify FCR triggers and inappropriate coping strategies; 3) facilitate the learning and use of new coping strategies, such as relaxation techniques, cognitive restructuring, communication strategies and the use of self-care; 4) increase tolerance for uncertainty; 5) promote emotional expression of specific fears that underlie FCR; and 6) re-examine life priorities and set realistic goals for the future. Each session is composed of exercices where participants have to answer questions, share with the group or watch videos. Furthermore, homework is assigned after each session to be completed before next week's session. Eligible participants will attend a one-on-one pre-therapy meeting with a study therapist to prepare them for the group work (i.e.: review expectations and assess whether group work is appropriate for the participant) and complete the 7-week FC-FORT intervention. Membership will be closed once groups are formed and the sessions have started to enhance group cohesiveness and consistency. Before starting the intervention, participants will receive a standardized manual describing each session's activities and assignments. All participants (including those in the wait list control group) will complete a questionnaire package pre intervention, post intervention, and at a three month follow up via Qualtrics. Additionally, participants will be asked to complete post session measures, namely the Working Alliance Inventory - Revised Short Form as well as the Group Cohesiveness Scale after the 1st, 4th and 7th sessions.

Therapist Training and Supervision.

To enhance therapist adherence to treatment, the therapists recruited for the study will be provided with a standardized FC-FORT manual and will be trained by the research psychologists through an online training. The research team will review the video of each session and the principal investigator will provide weekly 30-minute supervision to the therapists. Furthermore, the study will use an updated version of the fidelity checklist that was used to evaluate adherence during the previous FORT studies. If adherence is less than 80% on any session, the research team will provide additional over-the-telephone feedback to the therapists running the group. This approach to monitoring treatment integrity and fidelity has been successful in previous FORT studies.

Qualitative Assessment.

To gain further insights about the feasibility, acceptability, and potential clinical significance of the FC-FORT, all study participants will be asked to complete semi structured interviews. This will enable a holistic understanding of their experience of FC-FORT, elucidate key intervention processes, and identify additional secondary outcomes. Lastly, the research coordinator will attempt to interview participants who dropped out of the intervention, to understand any hindering factors. Consenting participants will be asked to complete a semi structured interview (30-60 minutes) about their experience of the intervention through videoconferencing.

Randomization

This study will use a mixed method randomized control trial design using a waitlist control group and 3 months follow up, with 18 participants per condition. To minimize attrition associated with waiting to enroll participants, block randomization will be used. Specifically, a list of 4 blocks with equal numbers of intervention (I) and wait list control (WLCG) groups (e.g. I-I-WLCG-WLCG; I-WLCG-WLCG-I, etc.) will be randomly created. Once the first 9 participants have been recruited, they will be assigned to whichever group came up first on the list. The next 9 participants will be assigned to the next group on the generated list until all 4 groups have been completed. Participants assigned to the WLCG will be offered the intervention after the 3-month period. To limit bias, each of the 4 blocks of the list will be in separate sealed envelopes that will be opened one at a time after 9 participants have been recruited.

Minimizing Dropouts and Attrition

To maximize attendance, as in our prior research, participants will be told during informed consent procedures about the importance of attending all 7 sessions to ensure benefit from the intervention. Participants will receive two email reminders about each upcoming session, along with "homework" and session pre-reading materials. They will be asked to inform group therapists if they are to be absent. For participants who miss a session, they will be offered one individual videoconference make-up session for their first missed session before the next group; they will not be offered subsequent make-up sessions for additional missed sessions to decrease the risk that this would encourage those who prefer individualized attention to miss group sessions. Participants who miss more than two sessions will be asked to stop the intervention and restart with the next available group. This approach was successfully tested in previous FORT studies. To minimize differential attrition from the WLCG participants, participants will be emailed monthly with an update about the wait time.

Feasibility and Acceptability Criteria.

The following criteria will be used to assess the feasibility and acceptability of FC-FORT: 1) ability to recruit 36 FC in 15 months; 2) ability to randomize these 36 FC; 3) ability to deliver FC-FORT to 27 FC in 15 months (25% dropout rate); 4) 80% completion of 6 out of the 7 sessions; 5) complete measures for 90% of participants; 6) ability to deliver FC-FORT as intended as measured by a fidelity rating of above 80% on 75% of reviewed sessions; and 7) FC satisfactory ratings \>than 80% in terms of its content, therapists, and mode of delivery.

Quantitative analysis.

Descriptive statistics will be used to report on FCR outcomes. A linear mixed-effect model analyses will be done on the secondary outcome measures pre- and post-intervention and at the 3-month follow-up. All analyses will use both an intent-to-treat and per protocol approaches. Known extraneous variables that could influence FCR (e.g., age, education, income, cancer stage) will be measured and control for, and monitor for participants' use of any additional psychological support at each data-collection time-points. Dependence of the group data will be analyzed with an intraclass correlation coefficient (p) using a multilevel model.

Qualitative Analysis.

Conventional content analysis will be used to analyse the qualitative data. Interviews will be audiotaped, transcribed verbatim, and managed using the qualitative software program NVivo. Transcripts will be systematically coded into anticipated (e.g., motivations to participate, benefits of participation) and emergent codes. This is an iterative process whereby an initial set of themes are coded, applied to new transcripts, and revised to adjust for new information, until no new codes emerge. Double coding of 80% of the interviews will be done by the research assistant. These codes will then be sorted into subcategories (ideally between 10 to 15).

It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy

It Is Time to Address Fear of Cancer Recurrence in the Family Caregiver: Adaptation, Feasibility, and Acceptability Study of an Online Version of the Fear Of Recurrence Therapy

Fear of Cancer Recurrence Inventory - Short Form (FCR-SF), range from 0-36 with higher scores indicating high levels of fear of cancer recurrence

Intolerance of Uncertainty Scale - Short Form (IUS-SF), range from 12-60 with higher scores indicating high levels of intolerance of uncertainty

Mishel Uncertainty in Illness Scale Short-Form, range from 5-25 with higher scores indicating high levels of uncertainty in illness

Why Worry Questionnaire (WWQ), range from 13-65 with higher scores indicating more positive beliefs about worrying

Cognitive Avoidance Questionnaire (CAQ), range from 25-125 with higher scores indicating higher use of avoidance as a coping strategy

Protective Buffering Scale (PBS), range from 10-50 with higher scores indicating high levels of protective buffering

Working Alliance Inventory - Revised Short Form (WAI-R-SF), Range from 12-60 with higher scores indicating a stronger therapeutic alliance

Group Cohesiveness Scale (GCS), Range from 7-35 with higher score indicating a stronger group cohesion

University of Ottawa

Professor

Neoplasms

Rare Diseases

Cholangiocarcinoma

Neoplasms, Unknown Primary

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Bile Duct Cancer

Eligible patients that present with Cholangiocarcinoma.

Eligible patients with cancer of unknown primary site (CUP).

Eligible patients that meet the definition of rare cancers (incidence of less than 6 per 100,000 in the United States).

Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.

FoundationOne CDx and FoundationOne Liquid CDx

Mary Oster

Shumei Kato, M.D

Razelle Kurzrock, M.D.

Vivek Subbiah, M.D.

Shumei Kato, M.D.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results.

This open label, non-randomized, multi-center, pragmatic study aims to establish whether patients with rare tumors can benefit from matched molecular therapy as dictated by their next-generation sequencing (NGS) results. The study leverages a remote consent and participation approach to open enrollment to all patients with rare tumors within the United States. Traditional, site-based patient consenting and participation is also available for enrollment to the study.

Each participant will undergo comprehensive genomic profiling (CGP) by Foundation Medicine Inc. (FMI) of their tumor as well as plasma circulating cell-free DNA. Plasma circulating cell-free DNA may be additionally collected for repeat CGP at various timepoints during the study.

The CGP findings will be provided by FMI directly to the treating physician and study sponsor TargetCancer Foundation (TCF), with TCF presenting cases with genomic findings to the Virtual Molecular Tumor Board (VMTB). The VMTB will analyze the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions. The resultant treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.

TCF-001 TRACK (Target Rare Cancer Knowledge) Study

The primary feasibility endpoint is the percent of participants who receive a molecularly targeted matched treatment after recommendation from the VMTB. Point estimates and confidence interval estimations will be calculated for percent of participants on matched treatments.

The primary efficacy endpoint is the progression-free survival (PFS) among participants who received the molecularly targeted matched treatment. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including progression-free survival (PFS). Cox regression analysis will be applied to model PFS by putative covariates such as performance status, type of tumor, prior lines of treatment, and whether matched treatments are received.

Tumor molecular profiles will be correlated to treatment outcome, assessed by measures including the response rate, the rate of stable disease (SD)\>6 months/partial response (PR)/complete response (CR), progression-free survival (PFS), PFS ratio (comparison of the PFS used after molecular profiling to PFS on prior treatment), time to treatment failure, and overall survival. Kaplan-Meier estimates will be constructed for time-to-event endpoints, including overall survival (OS).

Foundation Medicine

TargetCancer Foundation

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

This is a single arm pilot study of group base exercise

The BE-BALANCED program will run for 12-weeks, with participants attending group-based virtual supervised exercise sessions twice weekly. Participants will complete an individual in-person assessment at baseline and again at end of intervention to collect physical outcome measures and will complete questionnaires electronically using REDCap, (or mailed version). Follow-up assessments will be administered electronically to each participant using REDCap at 3-months after program completion (24 weeks post-baseline).

Be-Balanced

Kelly Mackenzie

Kelly P Lab

Kristin L Campbell

This study will explore the feasibility (suitability), efficacy (research-setting outcomes), and participant satisfaction of a virtually-supervised 12-week exercise and diet intervention for women with ovarian cancer. It will include exercise, behavior change strategies, and guidance around healthy eating. Participants will be instructed and supervised virtually in two exercise sessions weekly for 12 weeks by a professional trained to deliver the program. An additional 1 exercise session per week, completed independently, will be added from weeks 4-12 of the program. Finally participants will participate in two separate virtual group nutrition sessions. Assessments will occur at baseline, end-of-intervention, and 6 months post-baseline.

Purpose: To assess the feasibility, preliminary efficacy, and patient perspectives of a 12-week supervised, virtually-delivered exercise and healthy eating program for women living with and beyond ovarian cancer.

Hypothesis: The investigators hypothesize that the program will be feasible and will demonstrate efficacy, and that patient perspectives will be overall positive and in support of the program.

Justification: Women living with and beyond ovarian cancer exercise at levels below the general population, and are at an increased risk for falls. Exercise and healthy eating programming is not a part of routine care. This project has the potential to demonstrate a feasible and relatively low-cost option for offering such programming.

Objectives: the objectives of this program are: 1) Primary Objective: To measure the feasibility of delivering the BE-BALANCED program from a virtual (i.e. live video) setting. Feasibility will be evaluated per individual item based on a priori targets; 2) Secondary Objective: To evaluate the preliminary efficacy of the BE-BALANCED program; 3) Tertiary Objective: To evaluate patient satisfaction (post-intervention only)

Research Design: This study is a prospective single-arm feasibility study.

Statistical Analysis: The primary aim is feasibility. This will be evaluated using descriptive statistics, focusing on the program recruitment, attendance, attrition, and fidelity. For secondary and tertiary/exploratory aims, a repeated measures ANOVA will be performed for each measure to evaluate the change in outcomes from baseline and end of intervention (12-weeks) and 3-month follow-up. In addition to the RM-ANOVA, an effect size for each measure will be calculated based on the same time-frame comparisons. SPSS will be used to process data.

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer

Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer (The BE-BALANCED Study)

Overall satisfaction; measured on scale 0-7 with higher score meaning higher satisfaction.

Assessed by meeting accrual targets (number recruited)

Assessed as number of supervised virtual sessions that a participant attended, out of a total of 24 group exercise sessions, and number of self-directed sessions completed, out of a total of 9 sessions.

Assessed as number of drop-outs during the 12-week program.

Group Belonging Scale (0-20; higher is better)

Measured by the gait speed portion of The Short Physical Performance Battery. Measured in seconds.

Measured by 8 foot timed up and go (Seniors Fitness Test). Measured by distance in seconds.

Measured by 30-second chair stand (Seniors Fitness Test). Measured in repetitions completed.

Measured by 30-second biceps curl (Seniors Fitness Test). Measured in repetitions completed.

Measured by Functional Reach Test. Measured in centimeters.

Measured by the Six Minute Walk test. Measured in meters.

Measured using stadiometer. Measured in meters

Measured using a scale. Measured in kilograms

Aggregated measure of height and weight, reported in kilograms/meter\^2

Measured by 36-item Short Form Health Survey; Norm-based 0-100, higher score represents better health

Measured by Hospital Anxiety and Depression Scale; Score range 0-21, higher score is higher depression and anxiety.

Measured by Modified Godin Leisure Time Physical Activity questionnaire; Scoring range 0 - no specified maximum. Scoring \< 14 units "insufficiently Active" ; 14-23 is "moderately active" and \>=24 is "active".

Measured by standard falls calendar for the duration of the study as number of falls.

British Columbia Cancer Agency

University of British Columbia

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Syndrome

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Noonan Syndrome

Costello Syndrome

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Congenital Abnormalities

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Heart Defects, Congenital

Cardiovascular Abnormalities

Heart Diseases

Connective Tissue Diseases

Abnormalities, Multiple

Quality of Life

Neurofibromatosis

Neurofibromatosis Type 1

Cardiofaciocutaneous Syndrome

Legius Syndrome

Participants will begin their 1-week baseline EMA data collection period and then take part in intervention procedures immediately after enrollment to assess feasibility and acceptability.

Participants will begin their 1-week baseline EMA data collection period immediately after randomization and will begin receiving the 8-week intervention at the end of this week/beginning of the next week (depending on participant schedule).

After an initial 1-week baseline period for EMA data collection and 8 weeks of maintaining their usual routine (wait list period), participants will begin receiving the 8-week intervention.

8 weeks of maintaining usual routine followed by 8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

Waitlist

8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.

ACT Intervention

Staci M Peron, Ph.D.

Staci Peron, Ph.D.

Background:

RASopathies are a group of genetic diseases that affect a child s development. They cause physical, cognitive, and behavioral symptoms. Caring for a child with a RASopathy can be stressful. Acceptance and Commitment Therapy (ACT) is a therapy that helps people become more aware and accepting of difficult thoughts and feelings. ACT has been found to be helpful for parents with high parenting stress.

Objective:

To find out if Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy better cope with parenting stress.

Eligibility:

People aged 18 years or older who care for a child (younger than 18 years) with a RASopathy. The child must live with the caregiver at least 50% of the time.

Design:

The study is fully remote. Participants need a mobile device that can play audio and video and connect to the internet. They can borrow an iPod if needed.

Participants will download a free app called MetricWire. They will use this app to watch videos and answer questions.

The first 8 participants will be in a pilot study. They will receive the ACT intervention starting the first week after they begin the study.

After the pilot study, we will start a new phase called the randomized trial. In this phase, participants will have a 50-50 chance of being in the group that will start the intervention right away or the group that will start the intervention after about 2 months.

Participants will fill out surveys on 5 random days each week. These surveys have 7 questions and take about 2 minutes. They will also fill out 3 longer questionnaires: once before ACT begins, once just after the 8-week study period, and once about 3 months later. Questions will cover topics including:

Parenting stress

Life satisfaction

Self-compassion

Uncomfortable feelings and thoughts

Mindfulness

Participants will take part in an 8-week ACT intervention. They will have one 75-minute session with an ACT coach in the first week.

Participants will watch 9- to 17-minute videos each week. The videos talk about how to practice ACT techniques to cope with parenting stress.

Participants will have 20- to 30-minute coaching sessions in weeks 3 and 6. The coach will help them practice exercises and work through any problems.

Background:

* RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase (RAS-MAPK) cellular signaling pathway.
* Caregivers of children with a RASopathy are faced with numerous challenges related to the physical, cognitive, and behavioral symptoms associated with their child s condition.
* The use of virtual interventions has been increasing over the past decade, which increase accessibility and are especially critical during times of physical distancing, such as due to COVID-19.
* Similarly, Ecological Momentary Assessments (EMA) are being utilized more frequently in order to maximize ecological validity of results and minimize recall bias.
* To our knowledge, no psychological interventions have been investigated targeting parenting stress among caregivers of a child with a RASopathy.

Primary Objectives:

* Internal Pilot Study: To assess the feasibility (e.g., enrollment and attrition) and acceptability (e.g., satisfaction) of an Acceptance and Commitment Therapy (ACT) coping intervention on parenting stress for caregivers of a child with a RASopathy
* Randomized Controlled Trial (RCT): To compare Parental Stress Scale (PSS) changes from baseline to 8 weeks between the Immediate Intervention Arm and the Waitlist Control Arm

Eligibility:

* Caregiver (parent or legal guardian) of a child (\< 18 years) residing with them at least 50% of the time who has a diagnosis of RASopathy syndrome including NF1, Noonan Syndrome, Legius Syndrome, Cardiofaciocutaneous (CFC) syndrome, and Costello Syndrome, or another RASopathy
* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) or be willing to use an iPod provided by the study team
* Must score a 15 or higher total score on modified questions from the PSS to indicate at least a moderate level of parenting stress
* Ability to read and speak English

Design:

* This is an 8-week psychological intervention study that has two phases: the first, an internal pilot study, will enroll an initial, small cohort of caregivers (n = 8), all of whom will participate in the ACT intervention. (COMPLETE)
* Due to the success of the internal pilot study (with specific benchmarks met), the second phase of this study will be an RCT comparing participants who receive the intervention immediately (Immediate Intervention Arm) with those in a control group (Waitlist Control Arm). Participants randomized to the Waitlist Control Arm will cross over to receive the intervention after the waitlist period.
* The intervention for the RCT phase involves a baseline 90-minute coaching session and two follow-up coaching sessions with a therapist over video chat, followed by weekly prerecorded video modules that the participants can view at their convenience over the following 8 weeks.
* Participants will complete measures of parenting stress, mindfulness, psychological flexibility, self-compassion, and perceptions of child well-being at baseline, the 8-week post-intervention assessment, and a 3-month follow-up assessment. Additionally, the study will use EMA whereby questions will be sent electronically at random times and days (once a day at varying times on 5 days a week) during weeks 0-8 (the first week will serve as baseline data for comparison) for the Immediate Intervention Arm and weeks 0-18 for the Waitlist Control Arm using the Catalyst mobile applicatioon by MetricWire software.
* We plan to enroll 8 participants in the internal pilot phase and 56 participants in the RCT phase to account for the potential attrition of two caregivers from the intervention, for a total accrual target of 64 evaluable participants.

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Feasibility defined by compliance with viewing \>50% of the weekly videos (proposed target rate of 5 out of 8 videos watched; must watch at least 80% of each video), and 70% of participants attending both coaching sessions 2 and 3. Acceptability defined by descriptive data per caregiver reports of satisfaction on the Study Satisfaction survey (mean of questions 1-7 and 9).

RCT: Mean scores on the Parental Stress Scale (PSS) will be compared from pre- to post-intervention (baseline to 8 weeks between the immediate intervention arm and the wait list control arm.

Feasibility defined by compliance with daily surveys (target rate of 30 out of 40 surveys (75%) completed on average by each participant). Acceptability defined by post-intervention participant reports of satisfaction with completing daily EMA ratings on the Study Satisfaction survey.

We will examine pre- to post-intervention changes in scores on measures of psychological flexibility (MPFI-SF), self-compassion (SCS-SF), experiential avoidance (BEAQ), depression (PROMIS Depression 8a) and child affect (PROMIS Positive Affect Scale).

We will look for a significant indirect association between treatment arm assignment and pre- to post-intervention PSS changes via psychological flexibility as measured by the BEAQ.

National Cancer Institute (NCI)

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Chronic Disease

Lung Diseases

Liver Diseases

Gastrointestinal Diseases

Respiratory Tract Diseases

Chronic Graft Versus Host Disease

The standard of care response to COVID. Educational materials will be provided to patients via email. The package will include a combination of personalized exercises, and nutrition information for healthy eating. Participants will also receive a Garmin watch to track their activity over the intervention.

An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers, Dietitians and other participants. The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment. The 10-week nutrition program will be enabled at week 3 after a virtual dietitian assessment in week 2 (\~1 hour). The home programs will auto-progress. Participants will also receive a Garmin watch to track their activity over the intervention.

An app-based, "personnel-intensive" approach to virtual care with support through a combination of group-based interactions with Trainers, Dietitians and other participants, as well as one-on-one support with Exercise Trainers and Dietitians. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: up to seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming. Participants will also receive a Garmin watch to track their activity over the intervention.

App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.

Exercise & Nutrition

App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. Additional one-one-one exercise and nutrition support is provided too.

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.

Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care.

The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm).

Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.

INTRODUCTION:

COVID-19 related social distancing have a profound impact on vulnerable people living with chronic conditions, including cancer and organ failure. Pre-pandemic, many of these patients relied on and benefited from multidisciplinary supports and structured programming to maintain well-being and function. Many of these in-person supports are not currently available, which has disconnected these patients from the care they need to stay well.

Virtual modalities are a promising solution that allow multidisciplinary programs (i.e. exercise and nutrition) to continue to deliver support for these patients when social distancing doesn't allow these programs to run in-person. However, it's currently unclear whether virtual programming is acceptable in these populations, and what level of support is best in terms of benefits and costs.

The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.

OBJECTIVES:

1. As compared to control, assess the impact of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support) on: physical function and mental health outcomes.
2. As compared to the modeled costs of in-person programming, assess the cost of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support).
3. Assess the acceptability of the virtual exercise and nutrition programming to patients and members of the study team who deliver the intervention.

METHODS:

This is a mixed-methods, 12-week randomized controlled trial with randomization to one of three study groups with increasing virtual multidisciplinary support for outpatients. Participants will include people living with one of the following three chronic conditions: cancer, lung disease, or lung or liver disease (post-transplantation).

Group 1 - The standard of care response to COVID. Educational materials will be provided to patients via email. As needed, the package will include a combination of personalized exercises, disease-tailored tips for healthy eating and COVID precautions. Ad hoc telephone or virtual contact with patients will be at the providers' discretion.

Group 2 - An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers and other participants during live group exercise and nutrition classes (\~3/week). The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment and the 10-week nutrition program will be enabled at week 3 after a dietitian assessment in week 2. The home programs will auto-progress.

Group 3 - An app-based, "personnel-intensive" approach. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming.

OUTCOMES \& ANALYSES:

All analyses adhere to the intention-to-treat-principle (ITT). Fitness assessments and patient-reported outcomes will be collected at baseline and 12-weeks. Primary and secondary outcomes from these data will be analyzed using linear mixed models with random effects. Adherence and app acceptability (survey) will be compared between groups using the chi-square. Costs of each level of support will be compared with the cost of in-person programming using a publicly funded provincial payer perspective and will be presented in the Net Benefit framework.

Interviews will be conducted with participants, caregivers, and program instructors to determine program acceptability and barriers and facilitators. Inductive content analysis will be used to analyze qualitative data.

Heal-Me Personalized Online Nutrition and Exercise Routines

Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID

The difference in the pre- vs post-intervention change in proportion of "yes" answers to the single-item physical activity questionnaire from pre- to post-intervention between groups

The difference in the pre- vs post-intervention change in sedentary time, as self-reported on the ISAT between groups

The difference in the pre- vs post-intervention change in protein intake (grams) between groups, based on 3-day food record(s)

The difference in the pre- vs post-intervention change in calorie intake (kilocalories) between groups, based on 3-day food record(s)

The difference in the pre- vs post-intervention change in micronutrient intake (milligrams) between groups, based on 3-day food record(s)

The difference in the pre- vs post-intervention change in the 6-item COM-B scale between groups (score range: 0-120, higher scores indicate higher capability, opportunity, motivation)

The difference in the pre- vs post-intervention change in the UTAUT scale between groups (score range: 0-92, higher scores indicate higher app acceptance and use)

The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)

The difference in the pre- vs post-intervention change in UEFI score between groups (score range: 0-80, higher scores indicate higher function)

The difference in the pre- vs post-intervention change in # of repetitions completed over the Timed Sit-to-Stand between groups

The difference in the pre- vs post-intervention change in Timed One-Legged Stance between groups

The difference in the pre- vs post-intervention change in the # of steps completed in the 2MST between groups

The difference in the pre- vs post-intervention change in the sit-and-reach distance between groups

The difference in the pre- vs post-intervention change in step count and activity minutes (Garmin watch) between groups

The difference in the pre- vs post-intervention change in The World Health Organization-5 (WHO-5) Well-Being Index between groups (score range: 0-25, higher scores indicate higher well-being)

The difference in the pre- vs post-intervention change in resilience, as measures by the 10-Item Connor Davidson Resilience Scale, between groups (score range: 0-40, higher scores indicate higher resilience)

The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the SF-36, between groups (score range: 0-100, higher scores indicate a more favorable health state)

The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the EQ-5D-5L, between groups (visual analogue score range: 0-100, higher scores indicate a more favorable health state)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy	NCT05441384	Cancer Caregiver CBT Fear Cancer	Family Caregive...	18 Years -	University of Ottawa
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
Heal-Me Personalized Online Nutrition and Exercise Routines	NCT04666558	Cancer Lung Diseases Liver Diseases	Exercise & Nutr... Exercise & Nutr...	18 Years -	University of Alberta
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial	NCT05361811	Neurofibromatos... Noonan Syndrome Legius Syndrome Cardiofaciocuta... Costello Syndro...	Waitlist ACT Interventio...	18 Years -	National Institutes of Health Clinical Center (CC)
TCF-001 TRACK (Target Rare Cancer Knowledge) Study	NCT04504604	Rare Cancers Cholangiocarcin... Cancer of Unkno...	FoundationOne C...	18 Years -	TargetCancer Foundation
Targeted Physical Activity to Improve Mobility and Falls Risk in Women Living With Ovarian Cancer	NCT04911114	Ovarian Cancer	Be-Balanced	50 Years - 75 Years	University of British Columbia
Heal-Me Personalized Online Nutrition and Exercise Routines	NCT04666558	Cancer Lung Diseases Liver Diseases	Exercise & Nutr... Exercise & Nutr...	18 Years -	University of Alberta

Spots Global Cancer Trial Database for virtual

Every month we try and update this database with for virtual cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for virtual

Every month we try and update this database with for virtual cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for virtual cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.