Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

Not Applicable

Not yet recruiting

• Conditions: Lymphoma

• Registration Number: NCT07014293
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.

Detailed Description

This is a randomized controlled trial assessing the effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency-Lymphoma (SMART3RP-Lymphoma) compared to Enhanced Usual Care on 254 early post treatment lymphoma survivors. The SMART-3RP is a comprehensive, evidence-based mind body group program designed to help individuals adapt to chronic stress (i.e., increase their resilience). It understands the adjustment to chronic stress as a dynamic process, blending CBT, positive psychology and mind body tools to target key coping processes.

This trial seeks to answer the following questions:

* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in coping skills when compared to survivors randomized to enhanced usual care?

* Do factors, such as age, sex, race/ethnicity, rural/urban living, socioeconomic status, impact how survivors respond to the treatment?

Study Timeline

• Study First Submitted: 2025-05-23
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Study Start: 2026-01-01
• Primary Completion: 2030-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• English speaking adult (18 years or older at enrollment)
• Within 5 years of completing active, curative treatment for lymphoma (includes surgery, chemo-/immuno-/radiation therapy, or other)

Exclusion Criteria

• Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician
• Unwilling or unable to participate using telehealth platform

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)	Baseline to 3 month follow up	The Measure of Current Status Scale (MOCS-A) measures coping processes on 4 domains: ability to relax, recognize stress, elicit support, and restructure thoughts. It is a 13-item scale where each item is measured on a 0-4 scale.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life scores (Functional Assessment of Cancer Therapy (FACT-G))	Enrollment to 3 month follow up	The FACT-G is a 27 item measure of quality of life on 4 domains: physical, functional, emotional, and social. Each item is measured on a 0 (not at all) to 4 (very much) scale.
Change in Resilience scores (Current Experiences Scale (CES-23))	Enrollment to 3 month follow up	The CES-23 is a 23-item measure that assesses resilience on 6 dimensions: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. Each item is scored on a 0 (not at all) to 5 (to a very great degree) scale.
Change in Emotional Distress (anxiety and depression) based on the PROMIS-Anxiety 8a and PROMIS-Depression 8a	Enrollment to 3 month follow up	The PROMIS-Anxiety 8a and PROMIS-Depression 8a measure anxiety symptoms and depression symptoms, respectively. The measures are 8 items, where each item is scored on a scale of 1 (Never) - 5 (Always).
Change in Physical Health (PROMIS Physical Function-8b)	Enrollment to 3 month follow up	The PROMIS Physical Function-8b is an 8-item measure that assesses the ability to perform daily living activities. Each item is scored on a scale of 1 (Unable to do) to 5 (Without any difficulty).

Trial Locations

Locations (1)

Mass General Brigham; 🇺🇸 Boston, Massachusetts, United States