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Smart-3RP for Emotional Distress in Cancer Caregivers (ForTe Trial)
N/A
Recruiting
Led By Elyse Park, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
ForTe Trial Summary
This trial will compare the effects of Smart-3RP vs. online support groups for improving resilience & reducing distress in cancer patients & their caregivers.
Who is the study for?
This trial is for adult caregivers of cancer patients, and English-speaking adults with cancer treated at MGH. Caregivers must be identified by the patient and willing to participate. Patients should be within 3 months to 3 years post-curative therapy or diagnosed with metastatic disease but expected to live more than a year.Check my eligibility
What is being tested?
The study compares the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP), a virtual mind-body group treatment, against referral to an online support group, assessing which better improves resilience and reduces distress in participants.See study design
What are the potential side effects?
As SMART-3RP is a stress management program involving relaxation techniques, significant side effects are not anticipated. However, some individuals may experience emotional discomfort when discussing personal issues during sessions.
ForTe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Enrolled Participants (Feasibility)
Proportion of Intervention Satisfaction (Acceptability)
Secondary outcome measures
Health care utilization (exploratory outcome)
Improvement in Resilience (Exploratory outcome)
Improvement in stress coping (Exploratory outcome)
+3 moreForTe Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Smart-3RPExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual CareActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,545 Total Patients Enrolled
5 Trials studying Emotional Distress
843 Patients Enrolled for Emotional Distress
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,345 Total Patients Enrolled
Elyse Park, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult over 18, speak English, and am being treated for cancer at MGH.I finished my cancer treatment between 3 months and 3 years ago and may be on long-term therapy.I do not have a caregiver willing to participate.I am able to understand and consent to treatment, as confirmed by my doctor.I was diagnosed with metastatic disease between 6 months and 3 years ago and am expected to live more than a year.
Research Study Groups:
This trial has the following groups:- Group 1: Smart-3RP
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacant positions for this experiment?
"Allegations from clinicaltrials.gov suggest that this trial is not presently pursuing recruits. It was initially posted on June 1st 2023 and the most recent alteration to its details occurred 18th January 2021. While this study does not require candidates at present, there are 1073 other trials actively recruiting participants right now."
Answered by AI
What ultimate goals does this research endeavor seek to fulfill?
"At the end of a 3-month period, the primary outcome assessed in this clinical trial will be Feasibility Proportion among Enrolled Participants. Additionally, Exploratory Outcomes such as Resilience Improvement (measured with CES) and Stress Coping Growth (MOCS-A scale) are also monitored. As part of the feasibility assessment, researchers will analyse Intervention Session Completion rates to identify if at least 70% of participants have attended 6 out 9 available sessions."
Answered by AI
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