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NCT Number: NCT07014293

Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

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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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Giselle Perez, PhD

CONTACT

[email protected]

617-724-0765

Giselle Perez, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking adult (18 years or older at enrollment)
  • At least 6-months post-lymphoma diagnosis and 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 site PI or treating clinician
  • Unwilling or unable to participate using telehealth platform

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)

    Time frame: 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

  1. Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)

    Time frame: 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.

  2. Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)

    Time frame: 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.

  3. Change in Physical Health (PROMIS Physical Function-8b)

    Time frame: 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).

  4. Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)

    Time frame: 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.

  5. Change in Quality of Life Based on the PROMIS Global-10

    Time frame: 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.

  6. Change in Resilience scores (Current Experiences Scale (CES-23))

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 10, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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