Smart-3RP for Emotional Distress in Cancer Caregivers

(ForTe Trial)

Overseen By Elyse Park, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prognosis <1 year, Active psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 14 weeks

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

I finished my cancer treatment between 3 months and 3 years ago and may be on long-term therapy.

Patients able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study

I was diagnosed with metastatic disease between 6 months and 3 years ago and am expected to live more than a year.

Exclusion Criteria

I do not have a caregiver willing to participate.

Patients with a prognosis less than one year as determined by the treating oncology clinician

I am able to understand and consent to treatment, as confirmed by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 9 virtual sessions of the SMART-3RP program or are referred to a 14-week online support group

14 weeks

9 virtual sessions

Follow-up

Participants complete 3-month and 6-month questionnaires and optional hair sample collection for cortisol measurement

6 months

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?

Group I: Smart-3RP Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12214282/

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] ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8986336/

Testing psychosocial mediators of a mind–body resiliency ... Increased resiliency was significantly associated with increases in mindfulness, positive affect, and assertive social support-seeking.

3. mdpi.com mdpi.com/2039-4403/15/9/334

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 ...

4. ons.org ons.org/publications-research/onf/50/1/outcomes-stress-management-and-resiliency-training-smart-program

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12472820/

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] ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07139769

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_decline

Depressive 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.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03743415

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 ...