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Completed

NCT Number: NCT05702723

Building Resiliency Among Caregivers of Curvivors and Metavivors

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).

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMART-3RP

Behavioral

9 sessions of mind-body group treatment program via Zoom platform.

Other names: Stress Management and Resiliency Training-Relaxation Response Program

Enhanced Usual Care

Behavioral

14-week group-based, online support group through CancerCare.org.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: ForTe

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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