Clinical trial · Interventional
Building Resiliency Among Caregivers of Curvivors and Metavivors
Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Diagnosis | — | UNRESOLVED | — |
| Distress, Emotional | — | UNRESOLVED | — |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
| Smart-3RP | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Smart-3RP
- 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.
- interventionNames
- Behavioral: Smart-3RP
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- 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.
- interventionNames
- Behavioral: Enhanced Usual Care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGoshe 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. PMID 40606212