Building Resiliency Among Caregivers of Curvivors and Metavivors

Purpose

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

  • Stress
  • Cancer Diagnosis
  • Distress, Emotional

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: Smart-3RP
    9 sessions of mind-body group treatment program via Zoom platform.
    Other names:
    • Stress Management and Resiliency Training-Relaxation Response Program
Active Comparator
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.
  • Behavioral: Enhanced Usual Care
    14-week group-based, online support group through CancerCare.org.

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02215
Contact:
Elyse Park, MD
617-724-6836
epark@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Elyse Park, Ph.D.
617-724-6836
epark@partners.org

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.