An interventional study of Enhanced Usual Care and SMART3RP-Lymphoma in Lymphoma, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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:
Of note: This record describes our primary aim to compare the effects of SMART3RP-Lymphoma to enhanced usual care on lymphoma survivors' coping with the adjustment to posttreatment survivorship. While this trial will explore potential sociodemographic moderators of the main intervention effects on our primary aim (Aim 1), given the exploratory nature of these analyses (i.e., hypothesis-generating), we will not report the results of our moderation analyses in this record but rather focus on the main effects of the study intervention.
Exclusion Criteria:
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.
Other: Enhanced Usual Care
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.
Other: SMART3RP-Lymphoma
Participants will receive a singleevaluation with a site social worker along with a list of mental health, social or community resources . This most closely resembles the real-world care available to survivors on an outpatient basis, however, we call this enhanced usual care since proactive identification and referral of posttreatment survivors is not routinely done.
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.
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
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.
Time frame: Baseline to 3 month follow up
Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)
The Generalized Anxiety Disorder Scale-7 (GAD-7) is a 7-item self-report measure assessing symptoms of anxiety. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.
Time frame: Enrollment to 3 month follow up
Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing symptoms of depression. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 24. Higher scores indicate greater depressive symptom severity.
Time frame: Enrollment to 3 month follow up
Change in Physical Health (PROMIS Physical Function-8b)
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).
Time frame: Enrollment to 3 month follow up
Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)
The Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item self-report measure assessing overall quality of life across four domains: physical well-being, functional well-being, emotional well-being, and social/family well-being. Items are rated on a 0 (not at all) to 4 (very much) scale and summed to produce a total score ranging from 0 to 108. Higher scores indicate better quality of life.
Time frame: Enrollment to 3 month follow up
Change in Quality of Life Based on the PROMIS Global-10
The PROMIS Global-10 is a 10-item measure assessing overall quality of life. Responses are converted to standardized T-scores (mean = 50, standard deviation = 10), with possible scores ranging approximately from 0 to 100. Higher T-scores indicate better overall quality of life.
Time frame: Enrollment to 3 month follow up
Change in Resilience scores (Current Experiences Scale (CES-23))
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.
Time frame: Enrollment to 3 month follow up
Plan to share: No
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Massachusetts General Hospital