Building Resiliency Among Caregivers of Curvivors and Metavivors

Study Overview
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Brief Summary
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The main purpose of this research study is to assess the feasibility and participants' satisfaction of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) and compare this treatment with SMART-3RP versus referral to a group-based, online support group to see which is better for improving resilience and decreasing distress of participants with cancer and their caregivers. The name of the study intervention involved in this study is: Smart-3RP (virtual, mind-body group treatment program).

Detailed Description
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This pilot, randomized controlled trial assesses the feasibility, acceptability, and efficacy of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) for improving resiliency and decreasing distress among caregivers and cancer survivors compared to enhanced usual care. Participants will be randomly assigned into one of the study groups: Smart-3RP versus referral to a group-based, online support group. Randomization means that a participant is placed into a group by chance. Participation in this study is expected to last about 180 days. It is expected about 96 people made up of 48 patients and 48 caregivers will take part in this research study. The National Institutes of Health (NIH) is supporting this research by providing funding.

Official Title
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Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial

Conditions
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Stress, Cancer Diagnosis, Distress, Emotional

Intervention / Treatment
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* Behavioral: Smart-3RP
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Patients: English speaking adult patients with cancer (18 years or older) Treated at MGH, who are either within approximately: 3 months to 3 years after completing potentially curative therapy for cancer diagnosis including surgery, radiation, and/or chemotherapy or other novel therapies (e.g., immunotherapy, biological therapy). Patients can be on long- term maintenance hormonal or biological therapy at the time of enrollment. 6 months to 3 years after diagnosis of metastatic disease with an expected prognosis of >1 year as confirmed by the treating oncology clinician Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study Exclusion Criteria for Patients: Prognosis less than one year as determined by the treating oncology clinician Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician Patients without a caregiver who is willing to participate Inclusion Criteria for Caregivers: Adult caregiver (age 18 years or older). Identified by the patient as the spouse/partner or family member/friend.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart-3RP<br>Survivors-caregivers will be randomized together (dyad), stratified by survivor status: curvivor (participants who have completed curative therapy) or metavivor (participants will metastatic disease), using a random plan generator with 1:1 randomization. Participants will complete study procedures as outlined: Baseline questionnaires. 9 virtual sessions of Smart-3RP. 3-month questionnaires. Optional collections of hair samples at enrollment and 6-month follow-up period to measure cortisol concentration. 6-month questionnaires. Optional exit interview with study staff. | Behavioral: Smart-3RP<br>* 9 sessions of mind-body group treatment program via Zoom platform.<br>* Other names: Stress Management and Resiliency Training-Relaxation Response Program;|
| Active Comparator: Enhanced Usual Care<br>Survivors-caregivers will be randomized together (dyad), stratified by survivor status (curvivor/metavivor), using a random plan generator with 1:1 randomization. Participants will be referred to a 14-week online support group. | Behavioral: Enhanced Usual Care<br>* 14-week group-based, online support group through CancerCare.org.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Enrolled Participants (Feasibility) | Defined as the percent of survivors/caregivers who are eligible enroll, or ≥ 45% enrollment of eligible participants (≥96 enrolled of 213 eligible participants). | At Screening | 
| Proportion of Intervention Satisfaction (Acceptability) | Defined as the percent of survivors/caregivers who report overall intervention satisfaction, as 4/5 on Likert scales, or ≥ 75% of participants ( (≥72 of 96 participants). | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Study Retention (Feasibility) | Defined as the percent of survivors/caregivers who complete the 3-month follow-up survey, or ≥ 70% of participants (≥67 of 96 participants). | At 3 months | 
| Proportion of Intervention Session Completion (Feasibility) | Defined as the percent of survivors/caregivers who attend at least 6 out of 9 intervention sessions, or ≥ 70% of participants (≥67 of 96 participants) | up to 6 months | 
| Improvement in Resilience (Exploratory outcome) | Assessed by the Current Experiences Scale (CES), a 23-item measure. | At baseline and 3 months | 
| Improvement in stress coping (Exploratory outcome) | Assessed with the Measure of Current Status (MOCS-A), a 13-item scale. | At baseline and 3 months | 
| Health care utilization (exploratory outcome) | Having seen a primary care provider in past year | At baseline and 6 months | 
| Reduction of Chronic Stress | Assessed by Cortisol levels of hair samples. | At baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivors, Stress, Stress Management, Cancer Diagnosis, Emotional Distress