Building Resiliency Among Caregivers of Curvivors and Metavivors

Not Applicable

Completed

• Conditions: Stress; Distress, Emotional; Cancer Diagnosis
• Interventions: Behavioral: Smart-3RP; Behavioral: Enhanced Usual Care

• Registration Number: NCT05702723
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Start: 2023-06-10
• Primary Completion: 2024-10-01
• Status Verified: 2025-01
• Study Completion: 2025-01-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart-3RP	Smart-3RP	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.
Enhanced Usual Care	Enhanced Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Intervention Satisfaction (Acceptability)	At 3 months	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).
Proportion of Enrolled Participants (Feasibility)	At Screening	Defined as the percent of survivors/caregivers who are eligible enroll, or ≥ 45% enrollment of eligible participants (≥96 enrolled of 213 eligible participants).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States