Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT05702723
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients:
Exclusion criteria
for Patients:
Inclusion criteria
for Caregivers:
9 sessions of mind-body group treatment program via Zoom platform.
Other names: Stress Management and Resiliency Training-Relaxation Response Program
14-week group-based, online support group through CancerCare.org.
Time frame: At Screening
Defined as the percent of survivors/caregivers (counted as individuals) who are eligible and enroll, with a feasibility cutoff of ≥ 45% enrollment of eligible dyads (defined as a survivor + caregiver).
Time frame: At 3 months
Defined as the percent of participants (including survivors and caregivers as individuals) who report overall intervention satisfaction as greater than or equal to 4 on 5-point Likert scales, with an acceptability cutoff of ≥ 75% of participants. This metric is relevant only to participants randomized to the SMART-3RP condition.
Time frame: At 3 months
Defined as the percent of participants (including survivors and caregivers as individuals) who complete the 3-month follow-up survey, with a feasibility cutoff defined as ≥ 70% of participants.
Time frame: 3 months
Defined as the percent of participants (including both survivors and caregivers as individuals) who attend at least 6 out of 9 SMART-3RP intervention sessions, with a feasibility cutoff of ≥ 70% of participants. This is relevant only to participants randomized to the SMART-3RP.
Massachusetts General Hospital
Other
Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
Acronym: ForTe
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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