Resilience Program for Lymphoma Survivors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active psychiatric, cognitive comorbidity

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

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a resilience program can improve the quality of life for individuals who have recently completed treatment for lymphoma, a type of cancer. Participants will either join an 8-week resilience program (SMART3RP-Lymphoma) featuring relaxation techniques and stress management or a health education program that includes setting health goals and self-monitoring. Individuals who have completed lymphoma treatment in the past two years and speak English or Spanish may be eligible. As an unphased trial, this study provides a unique opportunity to enhance well-being after treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this resilience intervention is safe for lymphoma survivors?

Research shows that the SMART3RP-Lymphoma program is safe for participants. Studies have examined adherence to the program and participants' perceptions. For example, the original SMART-3RP program, which forms the basis for the lymphoma version, has been used with cancer survivors and has helped them build resilience. Participants reported no negative side effects.

The program includes relaxation techniques, stress management, and positive thinking. These activities are generally safe and aim to improve quality of life. The reviewed studies report no serious side effects or safety issues, suggesting that participants handle the program well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Resilience Program for Lymphoma Survivors, specifically the SMART3RP-Lymphoma intervention, because it offers a fresh approach to post-treatment care. Unlike standard care options that might focus solely on medical treatment and monitoring, SMART3RP-Lymphoma incorporates techniques like the relaxation response (RR), cognitive behavioral therapy (CBT) for stress management, and positive psychology strategies. These components aim to enhance mental resilience and personal growth, potentially improving overall quality of life for lymphoma survivors. By addressing both psychological and physical well-being, this approach could lead to more comprehensive recovery outcomes.

What evidence suggests that the SMART3RP-Lymphoma program is effective for improving quality of life in lymphoma survivors?

Research has shown that the SMART3RP-Lymphoma program, which participants in this trial may receive, can improve the quality of life for lymphoma survivors. Studies have found that it reduces stress and enhances positive feelings through relaxation techniques and positive thinking strategies. Participants in similar programs have reported mental and physical improvements. This program teaches stress-coping skills, aiding in managing post-cancer treatment challenges. Overall, early findings suggest it could be a valuable tool for enhancing the everyday lives of lymphoma survivors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English or Spanish speaking adults over 18 who finished their curative lymphoma treatment within the last two years. It aims to help survivors improve their quality of life after treatment.

Inclusion Criteria

I am 18 or older and speak English or Spanish.

I finished my lymphoma treatment less than 2 years ago.

Exclusion Criteria

Active psychiatric or cognitive comorbidity as determined by the site PI or treating clinician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 8 weekly virtual group sessions focusing on resilience and stress management

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for quality of life and resilience improvements

12 months

4 surveys across 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SMART3RP-Lymphoma

Trial Overview The study is testing a resilience-based program called SMART3RP-Lymphoma, which includes health education, to see if it can enhance the long-term well-being of individuals who have completed lymphoma treatment.

How Is the Trial Designed?

Group I: SMART3RP-Lymphoma Experimental Treatment 1 Intervention

Participants will participate in 8 weekly sessions. The intervention components include: * Eliciting the relaxation response (RR), * CBT strategies to improve stress management * Positive psychology strategies to achieve growth enhancement

Group II: Health Education Program Active Control 1 Intervention

Participants will participate in 8 weekly sessions. Components include: * education on the co-occurrence of mental and physical problems * goal setting for health behavior change * self-monitoring HEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8160021/

A virtual resiliency program for lymphoma survivors The SMART-3RP has demonstrated preliminary efficacy in improving psychological and physical health symptoms across different populations, including patients ...

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11203600

RePORT RePORTER - National Institutes of Health (NIH) | Specifically, this study aims to test the efficacy of SMART3RP- Lymphoma, compared to a Health Education Program in improving quality of life (primary outcome) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07014293

Increasing Resiliency Among Early Post-Treatment ... Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?

4. ascopubs.org ascopubs.org/doi/pdf/10.1200/OP-25-00214

The Essential Role of Lymphoma Clinicians in Guiding the ... Notably, treatment advances have dramatically improved patients' prognosis, resulting in 5-year survival rates of 89% for Hodgkin and 74% for ...

5. researchgate.net researchgate.net/publication/343563742_A_Pilot_Mind-Body_Resiliency_Intervention_Targeting_Fear_of_Recurrence_among_Cancer_Survivors

A Pilot Mind-Body Resiliency Intervention Targeting Fear of ... The SMART-3RP has demonstrated preliminary acceptability and efficacy for resiliency, relaxation, positive affect, and general stress reduction ...

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074822000348

Randomized Waitlist-Control Trial of a Web-Based Stress ... The primary study endpoints are the feasibility and acceptability of the Bounce Back program for AYA cancer survivors who are within 5 years ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00214

Bridging the Gap: The Essential Role of Lymphoma ... Strengths-based, resilience-based interventions, such as our team's SMART-3RP, are wellness focused, holistic, and empowering. They provide ...

8. researchgate.net researchgate.net/publication/393818837_Psychosocial_and_NF-kB_Activity_Effects_of_the_Stress_Management_and_Resiliency_Training_Relaxation_Response_Resiliency_Program_SMART-3RP_on_Patients_With_MGUS_and_Smoldering_Multiple_Myeloma_A_Random

Psychosocial and NF-κB Activity Effects of the Stress ... Conclusions Cancer survivors completing the SMART-3RP had increased resiliency, which was associated with improvements in mindfulness ...