Smart-3RP for Emotional Distress in Cancer Caregivers
(ForTe Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a virtual program called Smart-3RP, designed to help cancer patients and their caregivers manage stress and build resilience. Researchers aim to compare the program's effectiveness in reducing emotional distress against a 14-week online support group. It suits English-speaking cancer patients who have completed primary treatments in recent years or have stable metastatic disease, along with their identified caregivers. Participants will join virtual sessions and complete questionnaires. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance emotional well-being for many.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, patients can continue long-term maintenance hormonal or biological therapy during the study.
What prior data suggests that the Smart-3RP program is safe for participants?
Research has shown that the Smart-3RP program is easy for participants to handle. It helps reduce stress and boost resilience in various groups, including those with physical and mental symptoms. Studies have not identified any major negative effects from the program, suggesting that the treatment is generally safe for participants.12345
Why are researchers excited about this trial?
Unlike traditional support options for cancer caregivers, which often focus on general emotional support, Smart-3RP offers a unique approach by integrating stress management and resiliency training specifically tailored for caregivers. Researchers are excited about Smart-3RP because it combines cognitive-behavioral strategies with mindfulness techniques, which may provide more effective emotional relief and coping skills. Additionally, the program's virtual delivery allows for greater accessibility and convenience, making it easier for participants to engage with the treatment from their own homes.
What evidence suggests that the Smart-3RP program is effective for reducing emotional distress in cancer caregivers?
Research shows that the Smart-3RP program, which participants in this trial may receive, helps people manage stress and emotional challenges. Studies have found that it boosts resilience, enabling recovery from tough times, and lowers stress levels. Participants in this program reported increased awareness and a more positive attitude. They also found it easier to cope with stress related to cancer and its treatment side effects. This program has been especially helpful for individuals with various physical and emotional symptoms, making it a promising option for caregivers facing emotional stress.36789
Who Is on the Research Team?
Elyse Park, Ph.D.
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 9 virtual sessions of the SMART-3RP program or are referred to a 14-week online support group
Follow-up
Participants complete 3-month and 6-month questionnaires and optional hair sample collection for cortisol measurement
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced Usual Care
- Smart-3RP
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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 Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Study protocol for a pilot randomized trial building ...
The SMART-3RP has shown promising efficacy for improving resiliency and reducing stress among individuals with myriad physical and psychological symptoms [15,16] ...
Testing psychosocial mediators of a mind–body resiliency ...
Increased resiliency was significantly associated with increases in mindfulness, positive affect, and assertive social support-seeking.
Caring-Healing Modalities for Emotional Distress and ...
Higher levels of resilience have been associated with more effective management of cancer-related stress and treatment side effects [14], as well as lower rates ...
Outcomes of a Stress Management and Resiliency ...
The SMART program has been shown to provide improvements in resilience, anxiety, perceived stress, mindfulness, and QOL among breast cancer survivors (Loprinzi ...
5.
researchgate.net
researchgate.net/publication/392644366_Study_Protocol_for_a_Pilot_Randomized_Trial_Building_Resiliency_among_Caregivers_of_Cancer_Curvivors_and_Metavivors(PDF) Study Protocol for a Pilot Randomized Trial Building ...
Dyads randomized to the SMART-3RP will participate separately but simultaneously in 9 survivor- or caregiver-specific group sessions. Results ...
Caring-Healing Modalities for Emotional Distress and ...
The CHMs grouped under this category include Stress Management and Resiliency Training: a Relaxation Response Resiliency Program (SMART-3RP) [38] ...
Adapting Psychosocial Resiliency Intervention for Parents ...
A new adaptation of an evidence-supported intervention, the SMART-3RP program, to address psychological symptoms and promote well-being among parental ...
8.
researchgate.net
researchgate.net/publication/318052845_Depressive_symptoms_predict_cancer_caregivers'_physical_health_declineDepressive symptoms predict cancer caregivers' physical ...
This study examines changes in caregivers' physical health 2 to 8 years after their family members' cancer diagnosis and prospective predictors of that change.
Caregivers' and Cancer Survivors' Psychological Distress ...
Data and safety monitoring plan is described under Human Subjects. IPD Sharing Access Criteria. Data from this study will be available to other researchers ...
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