Building Resiliency Among Caregivers of Curvivors and Metavivors

Stress Clinical Trial

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Official title:

Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702723
• Other study ID #: 22-357
• Secondary ID: R21CA273785
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: Elyse Park, Ph.D.
• Phone: 617-724-6836
• Email: epark[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Diagnosis
• Disease
• Distress, Emotional
• Stress

Intervention

Behavioral:
• Smart-3RP
9 sessions of mind-body group treatment program via Zoom platform.
• Enhanced Usual Care
14-week group-based, online support group through CancerCare.org.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Enrolled Participants (Feasibility)	Defined as the percent of survivors/caregivers who are eligible enroll, or = 45% enrollment of eligible participants (=96 enrolled of 213 eligible participants).	At Screening
Primary	Proportion of Intervention Satisfaction (Acceptability)	Defined as the percent of survivors/caregivers who report overall intervention satisfaction, as 4/5 on Likert scales, or = 75% of participants ( (=72 of 96 participants).	At 3 months
Secondary	Proportion of Study Retention (Feasibility)	Defined as the percent of survivors/caregivers who complete the 3-month follow-up survey, or = 70% of participants (=67 of 96 participants).	At 3 months
Secondary	Proportion of Intervention Session Completion (Feasibility)	Defined as the percent of survivors/caregivers who attend at least 6 out of 9 intervention sessions, or = 70% of participants (=67 of 96 participants)	up to 6 months
Secondary	Improvement in Resilience (Exploratory outcome)	Assessed by the Current Experiences Scale (CES), a 23-item measure.	At baseline and 3 months
Secondary	Improvement in stress coping (Exploratory outcome)	Assessed with the Measure of Current Status (MOCS-A), a 13-item scale.	At baseline and 3 months
Secondary	Health care utilization (exploratory outcome)	Having seen a primary care provider in past year	At baseline and 6 months
Secondary	Reduction of Chronic Stress	Assessed by Cortisol levels of hair samples.	At baseline and 6 months