SMART3RP Program for Lymphoma Survivors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active psychiatric, cognitive comorbidity, others

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

Compensation: Varies

Number of Visits: 8

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 mind-body program, called SMART3RP-Lymphoma, can assist lymphoma survivors in managing life after treatment. Participants will join online group sessions that use techniques such as relaxation exercises, stress management, and positive thinking to enhance well-being. The trial will compare this program to typical care, which involves support from social workers. It is designed for English-speaking adults who completed lymphoma treatment within the last five years. As an unphased trial, this study provides a unique opportunity for participants to explore innovative methods to improve their quality of life post-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 focuses on a mind-body program for lymphoma survivors, so it's best to ask the trial organizers for more details.

What prior data suggests that the SMART3RP program is safe for lymphoma survivors?

Research has shown that participants have found the SMART3RP program manageable in past studies. Those who joined improved their ability to cope with challenges, and no major side effects occurred. The program includes techniques such as relaxation, stress management, and focusing on positive growth, which are generally safe. These methods have helped participants become more resilient and mindful. Current evidence suggests that the program is safe for lymphoma survivors transitioning to life after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART3RP-Lymphoma program because it offers a holistic approach to improving the well-being of lymphoma survivors. Unlike traditional treatments that primarily focus on physical recovery, this program combines relaxation techniques, cognitive-behavioral therapy (CBT), and positive psychology to address mental and emotional health. By teaching stress management skills and promoting positive growth, the program aims to enhance social support and compassion, which are often overlooked in standard care. This comprehensive focus on both mind and body sets it apart from existing options, potentially offering a more balanced recovery experience for survivors.

What evidence suggests that the SMART3RP-Lymphoma program is effective for lymphoma survivors?

Studies have shown that the SMART3RP program can improve both mental and physical health for various groups, including cancer survivors. Early results suggest that participants feel less stressed and more positive. They also learn better stress management and coping strategies. Participants in this trial will receive the SMART3RP-Lymphoma program, which uses methods like relaxation exercises and cognitive-behavioral therapy (CBT) to change negative thinking patterns. Overall, evidence suggests that SMART3RP is a promising way to help lymphoma survivors adjust to life after treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for early post-treatment lymphoma survivors who are transitioning into survivorship. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

I am 18 or older and speak English.

I finished my lymphoma treatment less than 5 years ago.

Exclusion Criteria

Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician

I am willing and able to use telehealth for my care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants participate in 8 weekly group sessions of the SMART3RP-Lymphoma program, delivered virtually, focusing on stress management and resilience training.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in coping skills, emotional distress, physical health, quality of life, and resilience from baseline to 3 months post-treatment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• SMART3RP-Lymphoma

Trial Overview The study is testing a mind-body resilience program called SMART3RP-Lymphoma against an enhanced usual care routine to see if it helps survivors better cope with post-treatment challenges.

How Is the Trial Designed?

Group I: SMART3RP-Lymphoma Experimental Treatment 1 Intervention

Participants will participate in 8 weekly group sessions, delivered virtually. The intervention components include: 1. Eliciting the relaxation response (RR) involves sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve stress management involves increasing awareness and identification of the components of one's stress response (negative thoughts, emotions, physical reactions, behaviors, and relational) and learning skills at each session to alter these components (e.g., cognitive restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on utilizing techniques and skills to promote positive growth. Skills focus on increasing social support, positive affect, and compassion.

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

Participants randomized to EUC will be referred to their site social work team. This most closely resembles the real-world care available to survivors on an outpatient basis. It is an enhanced version of usual care because proactive identification and referral of posttreatment survivors is not routinely done.

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 ...