Building Resiliency Among Caregivers of Curvivors and Metavivors

NCT ID: NCT05702723

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2025-01-01

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.

Conditions

Stress; Cancer Diagnosis; Distress, Emotional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Smart-3RP

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

Smart-3RP

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

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Stress Management and Resiliency Training-Relaxation Response Program

Eligibility Criteria

Inclusion Criteria

• 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

• Adult caregiver (age 18 years or older).
• Identified by the patient as the spouse/partner or family member/friend.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elyse Park, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elyse Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

References

Goshe BM, Barata A, Finkelstein-Fox L, Cloutier J, Farnam E, Holmbeck K, Waldron E, Perez GK, Malloy L, Miranda I, Hager W, Horick N, El-Jawahri A, Park E. Study protocol for a pilot randomized trial building resiliency among caregivers of cancer curvivors and metavivors. Contemp Clin Trials Commun. 2025 Jun 19;46:101506. doi: 10.1016/j.conctc.2025.101506. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40606212 (View on PubMed)

Other Identifiers

R21CA273785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-357

Identifier Type: -

Identifier Source: org_study_id