Building Resiliency Among Caregivers of Curvivors and Metavivors (ForTe)

Mass General Brigham

Status: Completed

Conditions: Cancer Diagnosis; Distress, Emotional; Stress

Treatments: Behavioral: Enhanced Usual Care; Behavioral: Smart-3RP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05702723

22-357

R21CA273785 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Smart-3RP

Experimental group

Description:

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.

Treatment:

Behavioral: Smart-3RP

Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care