Building Resiliency Among Caregivers of Curvivors and Metavivors (ForTe)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Stress; Distress, Emotional; Cancer Diagnosis
• Intervention / Treatment: Behavioral: Smart-3RP; Behavioral: Enhanced Usual Care

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elyse Park, Ph.D.; Phone Number: 617-724-6836; Email: epark@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Massachusetts General Hospital Cancer Center
      • Contact: Elyse Park, MD; Phone Number: 617-724-6836; Email: epark@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Smart-3RP; 9 sessions of mind-body group treatment program via Zoom platform.; Other Names: Stress Management and Resiliency Training-Relaxation Response Program
Active Comparator: 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.	Behavioral: Enhanced Usual Care; 14-week group-based, online support group through CancerCare.org.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elyse Park, Ph.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Stress; Stress Management; Cancer Survivors; Cancer Diagnosis; Emotional Distress
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 22-357; R21CA273785 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No