Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Digestive System Diseases

Lung Neoplasms

Anxiety Disorders

Breast Neoplasms

Depression

Depressive Disorder

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

biomarker analysis; questionnaire administration; survey administration; treatment as usual

biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.

biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.

Briefly presented in the following order, sessions will include: 1) Overview and Introduction to Stress Management 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with work and caregiver stress, 5) Strategies for maintaining energy and stamina with caregiver and work demands, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs to employers and your loved ones, and 8) Getting the support they need including work accommodations and/or legal protections (e.g., Family Medical Leave Act, Americans with Disabilities Act)

PEPRR

Pep-Pal program consisted of 11 sessions: 1) Introduction to stress management, 2) Stress and the mind body connection, 3) How thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty, 7) Managing changing relationships and communicating needs, 8) Getting the support they need; 9) Employment related challenges and resources for working caregivers; 10) Employment session one; 11) Employment session two

Pep-Pal

Cathy J Bradley, PhD

This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.

Specific Aims

* Evaluate the impact of PsychoEducation Paced Respiration and Relaxation (PEPRR) delivered remotely as Virtual-PEPRR or online as Pep-Pal on caregivers employed at the time of their patient's cancer diagnosis and preselected based on high self-reported distress.
* Evaluate patient psychological status and healthcare utilization in patients whose caregivers received Virtual-PEPRR or Pep-Pal versus TAU
* Evaluate whether caregivers employment outcomes are associated with patient symptom management as an exploratory question.

OUTLINE: Caregivers are randomized to one of 3 groups (1:1:1) 1) Treatment as usual (TAU), 2) Virtual-PEPRR, or 3) Pep-Pal.

* Group I (treatment as usual \[TAU\]): Caregivers randomized to TAU will not participate in the stress management interventions. The TAU condition for this study takes into account published recommendations for an adequate representation of TAU. All participants regardless of randomization will be encouraged to use available psychological resources.
* Group II (Virtual PsychoEducation Paced Respiration and Relaxation \[Virtual-PEPRR\]): Caregivers participating in the Virtual-PEPRR intervention will consist of eight 60-75 minute video or telephone sessions. Each Virtual-PEPRR session will be devoted to a specific topic with the goal of assisting the caregiver in developing and applying stress-management skills both in caregiving as well as in their work setting. Sessions include problem-solving, identifying cognitive distortions, application of relaxation techniques such as the emWave2, acquiring new coping skills, utilizing social support, and establishing appropriate goals, and finding support. All caregivers in Virtual-PEPRR will be provided a Caregiver Workbook that includes information about the session topics and homework assignments.
* Group III (Pep-Pal): Pep-Pal is a mobilized version of Virtual-PEPRR. Pep-Pal includes eleven web-based video modules replicate essential components of each session of Virtual-PEPRR, but in shorter format (\<20 minute. duration) with engaging relaxation exercises. The modules include learning skills in problem-solving, identifying cognitive distortions, using relaxation techniques, acquiring new coping skills, utilizing social support, establishing suitable goals, and finding support. Pep-Pal includes "Mini-Peps" which are video guided, 3-minute stress reduction exercises that the caregiver can access any time. Caregivers randomized to Pep-Pal will complete modules at times that are convenient and web-accessible by smartphone, tablet, laptop, or desktop computer. Caregivers can complete more than one module a week, repeat any session, and access the Mini-Peps as frequently as desired.

Caregivers and patients undergo psychosocial assessments prior to randomization, and at 3 months, 6 months, 9 months and 1 year after baseline. At each phase, caregivers and patients will complete battery of questionnaires that includes the Center for Epidemiological Studies-Depression scale (CES-D), the perceived stress scale (PSS), and the State-Trait Anxiety Inventory (STAI). Caregivers will be asked monthly to complete eight very short questions Patient-Reported Outcomes Measurement Information System (PROMIS). Additionally the patient will complete the MD Anderson Symptom Inventory each time while the caregiver completes questionnaires will cover details about how being a caregiver has affected their lives, details about employment, insurance and accommodations, general physical and mental well-being, and the impact Covid-19 has had on their lives. The patient and the caregiver will additionally complete a demographic questionnaire that includes questions regarding age, diagnosis, income, and other standard questions regarding nutrition, health behaviors, and health services utilization. At study completion, an exit questionnaire will address each subject's evaluation of the study and the group in which they were assigned.

Saliva and hair samples from caregivers will be collected every three months: baseline, 3 months, 6 months, 9 months and 1 year after baseline.

Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.

Cancer Caregivers and Their Struggle(s) Between Work and Family

Change in caregiver depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.

Change in caregiver anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

Change in caregiver perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.

Caregiver electronic health records and supplemented by Colorado All Payer Claims Data and self-report

Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis.

Telomere length was assessed as a measure of cellular aging in blood samples from participants.

Change in patient depressive symptoms. Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.

Change in patient anxiety. The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

Change in patient perceived stress. The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.

Patient electronic health records and supplemented by Colorado All Payer Claims Data

Patient symptom management. the MD Anderson Symptom Inventory (MDASI) core scale, which assesses 13 symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, memory problems, lack of appetite, drowsiness, dry mouth, numbness, sadness, and vomiting) on a 0-10 scale.

Caregiver self-report employment and weekly hours worked questions from Current Population Survey (CPS)

Caregiver self-report job satisfaction. Job satisfaction is measured by a single-item assessment tool assessing whether or not the participant was satisfied with their current job. Satisfaction was measured on a 0-7 scale. Higher score indicates a higher level of satisfaction.

National Cancer Institute (NCI)

University of Colorado, Denver

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

Quality of Life

Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.

Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.

PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.

Prostate Cancer Education and Resources for Couples (PERC)

The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.

usual care plus NCI website

Lixin (Lee) Song, RN, PhD

In this study, the investigators propose to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC) in a randomized clinical trial. A two-group (PERC versus National Cancer Institute (NCI) website plus treatment as usual) randomized controlled design will be used, and data will be collected at baseline (T1), 4 (T2), 8 (T3), and 12 months (T4) among 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 600 participants in total).

This randomized clinical trial aims to test the efficacy of a couple-focused, web-based tailored prostate cancer symptom management program, Prostate Cancer Education and Resources for Couples (PERC). The study participants will include 300 patients completing initial treatment for localized prostate cancer and their intimate partners (i.e., 300 dyads and 600 individuals). After informed consent, we will conduct baseline assessment (T1), randomly assign eligible participants to either PERC or the National Cancer Institute (NCI) website, and then collect data at 4 (T2), 8 (T3), and 12 months (T4) post-T1.

The investigator and data collectors will be masked to intervention.

Efficacy of a Couple-Focused mHealth Symptom Self-management Program

Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners

FACT-G will be used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General (FACT-G) is a 27 item survey which assesses physical, social/family, emotional, and functional well being on a 5 point likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. Higher scores indicate better well-being.

PROMIS Pain Interference - Short Form 6b will be used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference.

PROMIS Fatigue -Short Form 7a will be used to measure change in Fatigue among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The fatigue sub-scale will measure the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue.

PROMIS Sleep Disturbance Short Form 8b will be used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The sleep disturbance sub-scale measures the extent to which participant experience sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance.

PROMIS-Emotional Distress-Anxiety Short Form 7a will be used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value.The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale, where higher scores reflect higher anxiety.

PROMIS-Emotional Distress-Depression Short From 8b will be used to measure change in depression scores among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Total raw scores will be translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. Change from baseline is the post-Baseline values minus the Baseline value. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale, where higher scores indicate greater depressive symptoms.

The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in health related quality of life scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value. It contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.

The Prostate Cancer Related Symptoms Caregiver Short Form will be used to measure changes in caregiver scores from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline value minus the Baseline value.The questionnaire is a 4-item assessment about how the patient's hormone, sexual, bowel, and urinary function has affected the caregiver over the past 4 weeks. Items are ranked on a 5-point Likert Scale where higher scores indicate greater bother associated with the patient's symptoms.

The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

PROMIS Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.

The ISEL-12 will be used to measure change in social support from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1) among patients and their partners. The ISEL-12 is a 12 item measure, where higher scores indicate greater social support. Change from baseline is the post-Baseline values minus the Baseline value.

Appraisal of Illness scale will be used to measure change in perception of prostate cancer and related issues among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value.The Appraisal of Illness scale is a 20 item measure that uses Likert Scales ranging from Very False to Very True.

Change in Dietary Risk Assessment scores will be used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients and their partners will be asked how often they consume different foods over the past month or week and will respond using a Likert Scale to report how much of each food item they have consumed.

The Measure of Older Adult's Sedentary Time will be used to measure change in self-reported sedentary time from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants will self-report how much time they spend doing various sedentary activities during the past week.

National Institute of Nursing Research (NINR)

UNC Lineberger Comprehensive Cancer Center

Cristina Hendrix, DNS

The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.

The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.

Baseline demographic data about the caregiver and patient will be collected at patient beside prior to hospital discharge. Qualitative interviews will be conducted with the cancer caregivers in their home at 1-week after their loved one was discharged from the hospital, and at 2-weeks after discharge from the hospital. This study utilizes a qualitative descriptive design.

Older Cancer Caregiver Needs Post Hospital Discharge

Needs of Older Caregivers of Adults With Cancer In the First 2 Weeks Following Hospital Discharge

Explore the needs (e.g., psychosocial) of older adults caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these needs vary by spirituality and relationship to the care recipient.

Identify the strategies used by older caregivers during the first and second weeks after hospital discharge, and determine how these strategies vary by spirituality and relationship to the care recipient.

Describe the preferences of support and assistance (e.g., family/friends) of older caregivers in caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these preferences vary by spirituality and relationship to the care recipient.

Explore whether caregiver needs and preferences vary with time (1 week versus 2 weeks post hospital discharge).

The Reed Foundation, Ruth Landes Memorial Research Fund

Duke University

Symptoms and General Pathology

Inflammation

Caregiver Burden

Behavioral Symptoms

Stress, Psychological

8 sessions of Emotion Regulation Therapy.

Emotion Regulation Therapy

Mia S O'Toole, MSc

Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).

PURPOSE:

The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.

AIMS AND HYPOTHESES:

Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.

PARTICIPANTS AND PROCEDURES:

ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology, Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the investigators wanted to include caregivers of patients with lung and colorectal cancer only. However, in order to be able to include caregivers at a faster pace, it was decided - after one month during which only two caregivers were included - to broaden the patient group. Furthermore, it was decided that more than one IC per patient could participate.

After giving informed consent, participants will be randomized to Emotion Regulation Therapy (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a number of self-report the process measures. Cancer patients will be assessed pre- and post ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before and after the intervention as well as at follow-ups.

Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats is, pre, mid and post) of a medium effect size (d=0.5) to be significant.

Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial

Questionnaire measuring burden in ICs and quality of life cancer patients, respectively

Questionnaire measuring anxiety and depression

Questionnaire measuring emotion regulation

Questionnaire measuring psychological distancing

Serum-derived pro-inflammatory markers (only pre and post therapy)

2 items (actual and wanted emotional closeness) rated on a 0-10 scale

University of Aarhus

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to individuals diagnosed with lung cancer (survivor).

The KY LEADS Survivorship Care condition involves providing a targeted and tailored psychosocial support intervention to caregivers of individuals diagnosed with lung cancer (caregiver)

Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment.

Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment

KY LEADS Survivorship Care

Jamie L Studts, PhD

The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.

Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

Kentucky LEADS Lung Cancer Survivorship Care Program - Survivors and Caregivers

Study Feasibility - Survivor survey completion rate (3A)

Study Feasibility - Survivor drop-out rate (3B)

Study Feasibility - Rate of missing survivor/caregiver data (3C)

Study Efficacy - Impact on survivor quality of life (FACT-G) (4A1)

Study Efficacy - Impact on survivor lung cancer specific quality of life (FACT-L) (4B1)

tudy Efficacy - Impact on caregiver quality of life (C-QoL) (4A2)

Study Efficacy - Impact on caregiver self-efficacy (CSES) (4B2)

Participating survivor intervention acceptability (1A)

Participating survivor intervention satisfaction (1B)

Participating survivor intervention uptake (1C)

Intervention Feasibility - study accrual rate (2A)

Intervention Feasibility - SC Specialist ratings (2B)

University of Louisville

Lung Cancer Alliance

Bristol-Myers Squibb

Jamie Studts

Principal Investigator

Burnout, Psychological

Participants assigned to this arm will be able to attend the online peer program upon entering the study.

Participants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months.

Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.

Cancer Connect Program

Cecilia M Votta, PhD

Cynthia Neben, PhD

Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.

Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.

Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.

Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months.

Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers

BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers

Patients: EORTC Core Quality of Life (CLC-C30), Survivors: Quality of Life Adult Cancer Survivors (QLACS), Caregivers: WHO Quality of Life Scale (WHO-QOL)

Color Health, Inc.

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Neoplasms

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.

Participants assigned to this arm will receive the standard of care that is provided to all patients.

Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Lixin Song, RN, PhD

This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.

Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study

Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.

Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.

Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.

Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.

Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.

The total number of ostomy-related followup visits, emergency room use and re-admissions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.	NCT04739696	Breast Cancer Lung Cancer Colon Cancer Solid Tumor, Ad...	PEPRR Pep-Pal	18 Years - 64 Years	University of Colorado, Denver
Efficacy of a Couple-Focused mHealth Symptom Self-management Program	NCT03489057	Prostate Cancer	Prostate Cancer... usual care plus...	40 Years - 75 Years	UNC Lineberger Comprehensive Cancer Center
Older Cancer Caregiver Needs Post Hospital Discharge	NCT02099526	Cancer Caregive...		18 Years -	Duke University
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial	NCT02322905	Anxiety Depress...	Emotion Regulat...	18 Years - 69 Years	University of Aarhus
Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program	NCT02989974	Lung Cancer	KY LEADS Surviv...	18 Years -	University of Kentucky
Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers	NCT06353178	Cancer Caregiving Stre... Caregiver Burno... Survivorship	Cancer Connect ...	18 Years -	Color Health, Inc.
Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.	NCT04739696	Breast Cancer Lung Cancer Colon Cancer Solid Tumor, Ad...	PEPRR Pep-Pal	18 Years - 64 Years	University of Colorado, Denver
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)	NCT04492007	Colorectal Canc... Bladder Cancer Ovarian Cancer Cervical Cancer Uterine Cancer	Patient-Reporte...	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for caregiving

Every month we try and update this database with for caregiving 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 caregiving

Every month we try and update this database with for caregiving 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 caregiving 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.