Clinical trial NCT05702723: Building Resiliency Among Caregivers of Curvivors and Metavivors
Official title: Building Resiliency Among Caregivers of Curvivors and Metavivors: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Cancer Diagnosis
Distress, Emotional
Keywords: Stress
Stress Management
Cancer Survivors
Cancer Diagnosis
Emotional Distress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Primary outcomes:
measure: Proportion of Enrolled Participants (Feasibility)
timeFrame: At Screening
measure: Proportion of Intervention Satisfaction (Acceptability)
timeFrame: At 3 months
Secondary outcomes:
measure: Proportion of Study Retention (Feasibility)
timeFrame: At 3 months
measure: Proportion of Intervention Session Completion (Feasibility)
timeFrame: up to 6 months
measure: Improvement in Resilience (Exploratory outcome)
timeFrame: At baseline and 3 months
measure: Improvement in stress coping (Exploratory outcome)
timeFrame: At baseline and 3 months
measure: Health care utilization (exploratory outcome)
timeFrame: At baseline and 6 months
measure: Reduction of Chronic Stress
timeFrame: At baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elyse Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: