A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship

Not Applicable

Not yet recruiting

• Conditions: Lymphoma

• Registration Number: NCT07013435
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.

Detailed Description

The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.

The main questions it aims to answer are:

* Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?

* Will improvements in resiliency lead to improvements in quality of life?

To answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.

Participants will:

* Fill out 4 surveys across 12 months

* Participate in 8 weekly, virtual group sessions

* Submit hair cortisol samples

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
• Primary Completion: 2029-01
• Study Completion: 2030-01

Recruitment & Eligibility

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

Inclusion Criteria

• English or Spanish speaking adults (18+ at time of enrollment)
• Within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of Life (QoL): Change in PROMIS-29	From enrollment to 6 month follow up	To examine the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) in improving quality of life in early posttreatment lymphoma survivors. Quality of life will be measured using the PROMIS-29 which assesses physical, functional, emotional, and social quality of life. Each survey item is measured on a 1-5 scale. The unit of measurement is a score on a scale.

Secondary Outcome Measures

Name	Time	Method
Resilience: Change in Scores on the Current Experiences Scale (CES)	Enrollment to 3 month follow up	To compare the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) on resilience in posttreatment lymphoma survivors. Resilience will be measured by the Current Experiences Scale (CES). The CES is a 23-item measure that assesses the following domains of resilience on 0-5 scale: appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors. The unit of measurement is a score on a scale.

Trial Locations

Locations (1)

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