Building Resiliency Among Caregivers of Curvivors and Metavivors (ForTe)

March 24, 2026 updated by: Elyse Park, PhD, Massachusetts General Hospital

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
    • 3 months 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: At Screening
Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver).
At Screening
Proportion of Intervention Satisfaction (Acceptability)
Time Frame: At 3 months
Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition.
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Study Retention (Feasibility)
Time Frame: At 3 months
Defined as the percent of participants (including survivors and caregivers as individuals) who complete the 3-month follow-up survey, with a feasibility cutoff defined as ≥ 70% of participants.
At 3 months
Proportion of Intervention Session Completion (Feasibility)
Time Frame: 3 months
Defined as the percent of participants (including both survivors and caregivers as individuals) who attend at least 6 out of 9 SMART-3RP intervention sessions, with a feasibility cutoff of ≥ 70% of participants. This is relevant only to participants randomized to the SMART-3RP.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Elyse Park, Ph.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

January 1, 2025

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)

April 13, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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