Building Resiliency Among Caregivers of Curvivors and Metavivors (NCT05702723) | Clinical Trial Compass
CompletedNot Applicable
Building Resiliency Among Caregivers of Curvivors and Metavivors
United States94 participantsStarted 2023-06-10
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Enrolled Participants (Feasibility)
Timeframe: At Screening
2
Proportion of Intervention Satisfaction (Acceptability)