Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

NCT07014293 — Not applicable, Recruiting, 254 participants, Massachusetts General Hospital

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RegistryNCT07014293
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment254 (Estimated)
SponsorMassachusetts General Hospital (Other)
ConditionsLymphoma
InterventionsEnhanced Usual Care, SMART3RP-Lymphoma (Other)
Datesstart 2026-09-03, primary completion 2030-07-01 (estimated), completion 2030-07-01 (estimated), first posted 2025-06-10, last updated 2026-09-28
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Lymphoma All trials of Enhanced Usual Care All trials of SMART3RP-Lymphoma

-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.

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+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?

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.

+Arms and interventions

ArmTypeInterventionsDescription
Enhanced Usual CareOtherOther: Enhanced Usual CareParticipants 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.
SMART3RP-LymphomaExperimentalOther: SMART3RP-LymphomaParticipants 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.
  • Enhanced Usual Care (Other): 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.
  • SMART3RP-Lymphoma (Other): 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7) [Enrollment to 3 month follow up]: 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.
  • Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8) [Enrollment to 3 month follow up]: 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.
  • 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).
  • Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G) [Enrollment to 3 month follow up]: 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.
  • Change in Quality of Life Based on the PROMIS Global-10 [Enrollment to 3 month follow up]: 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.
  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* English speaking adult (18 years or older at enrollment)
* Is at least 6 months post-diagnosis and a) is currently undergoing lymphoma treatment (includes surgery, chemotherapy/immunotherapy/radiation therapy, or other) with evidence of treatment response or disease control; or b) has completed lymphoma treatment (e.g., chemotherapy/immunotherapy/radiation therapy, surgery or other) within the past 2 years and has disease control at treatment completion; patients may still be on maintenance treatment to prolong disease control.

Exclusion Criteria:

* Has not initiated treatment for lymphoma.
* Has worsening, progressive, or uncontrolled disease that is not responding to treatment.
* Active Psychiatric, medical or cognitive comorbidity as determined by site PI or treating clinician
* Unwilling or unable to participate using telehealth platform

+Locations (1)

FacilityCityCountryStatus
Mass General BrighamBoston, MassachusettsUnited StatesRecruiting