Building Resiliency Among Caregivers of Curvivors and Metavivors

Trial Title: Building Resiliency Among Caregivers of Curvivors and Metavivors

NCT ID: NCT05702723

Condition: Stress
Cancer Diagnosis
Distress, Emotional

Conditions: Official terms:
Disease

Conditions: Keywords:
Stress
Stress Management
Cancer Survivors
Cancer Diagnosis
Emotional Distress

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Smart-3RP
Description: 9 sessions of mind-body group treatment program via Zoom platform.
Arm group label: Smart-3RP

Other name: Stress Management and Resiliency Training-Relaxation Response Program

Intervention type: Behavioral
Intervention name: Enhanced Usual Care
Description: 14-week group-based, online support group through CancerCare.org.
Arm group label: Enhanced Usual Care

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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Massachusetts General Hospital Cancer Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Elyse Park, MD

Phone: 617-724-6836
Email: epark@partners.org

Start date: June 10, 2023

Completion date: January 1, 2025

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05702723