Smart-3RP for Emotional Distress in Cancer Caregivers

(ForTe Trial)

Overseen By Elyse Park, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prognosis <1 year, Active psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 14 weeks

94 Participants Needed

Trial Summary

What is the purpose of this 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).

Research Team

Elyse Park, Ph.D.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adult caregivers of cancer patients, and English-speaking adults with cancer treated at MGH. Caregivers must be identified by the patient and willing to participate. Patients should be within 3 months to 3 years post-curative therapy or diagnosed with metastatic disease but expected to live more than a year.

Inclusion Criteria

I finished my cancer treatment between 3 months and 3 years ago and may be on long-term therapy.

I was diagnosed with metastatic disease between 6 months and 3 years ago and am expected to live more than a year.

Patients 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

Patients with a prognosis less than one year as determined by the treating oncology clinician

I do not have a caregiver willing to participate.

I am able to understand and consent to treatment, as confirmed by my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 9 virtual sessions of the SMART-3RP program or are referred to a 14-week online support group

14 weeks

9 virtual sessions

Follow-up

Participants complete 3-month and 6-month questionnaires and optional hair sample collection for cortisol measurement

6 months

Treatment Details

Interventions

• Enhanced Usual Care
• Smart-3RP

Trial Overview The study compares the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP), a virtual mind-body group treatment, against referral to an online support group, assessing which better improves resilience and reduces distress in participants.

Participant Groups

Group I: Smart-3RP Experimental Treatment 1 Intervention

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 II: Enhanced Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+