CClinicalTrials.gg
RecruitingNCT07013435Updated Sep 28, 2026

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

An interventional study of Health Education Program and SMART3RP-Lymphoma in Lymphoma, sponsored by Massachusetts General Hospital. Recruiting at 2 sites 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

Phase
Not applicable
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Lymphoma

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Keywords

  • quality of life
  • psychosocial intervention
  • supportive care
  • cancer survivorship
  • resilience
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • English or Spanish speaking adults (18+ at time of enrollment)
  • Within 1-5 years of completing active treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other); individuals may be on maintenance treatment.

Exclusion criteria

Exclusion Criteria:

  • Active psychiatric, medical concern or cognitive comorbidity as determined by the site PI or treating clinician
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
254 participants (estimated)

Study arms

  • Active comparator
    Health Education Program

    Participants will participate in 8 weekly sessions. Components include: * education on the co-occurrence of mental and physical problems * goal setting for health behavior change * self-monitoring HEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP

    Other: Health Education Program

  • Experimental
    SMART3RP-Lymphoma

    Participants will participate in 8 weekly sessions. The intervention components include: * Eliciting the relaxation response (RR), * CBT strategies to improve stress management * Positive psychology strategies to achieve growth enhancement

    Other: SMART3RP-Lymphoma

Interventions

  • OtherHealth Education Program

    8 weekly sessions that include education on the co-occurrence of mental and physical problems, goal setting for health behavior change, and self-monitoring. Each session includes basic didactic information, interactive application of the information, and open discussion of didactic material.

  • OtherSMART3RP-Lymphoma

    The SMART3RP-lymphoma is a group program that, through a variety of mind-body approaches, such as imagery, relaxation, and yoga, seeks to buffer stress and promote psychological resiliency and physical well-being.

05

What researchers measure

Primary outcomes

  1. Quality of Life (QoL): Change in PROMIS-29

    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.

    Time frame: From enrollment to 6 month follow up

Secondary outcomes

  1. Resilience: Change in Scores on the Current Experiences Scale (CES)

    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.

    Time frame: Enrollment to 3 month follow up

Other outcomes

  1. Correlation between scores on measures of Resilience (CES) and Quality of Life (PROMIS-29)

    The investigators will determine how resilience at 3 months correlates to quality-of-life improvements at 6 and 12 months. Resilience will be measured by the Current Experiences Scale (CES), which is a 23-item measure. The CES assesses 6 domains of resilience including appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and health behaviors). Quality of life will be measured by the PROMIS-29 which is a 29-item measure. It assesses physical, functional, emotional, and social quality of life domains. The unit of measurement for both assessments are scores on a scale.

    Time frame: 3, 6 and 12 months

06

Study locations

2 of 2 sites recruiting
  • Mass General Hospital
    Boston, Massachusetts 02114, United States
    • Giselle K Perez, PhD · Contact · gperez@mgh.harvard.edu · 617-724-0765
    • Giselle K Perez, PhD · Principal investigator
    Recruiting
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — de-identified information as required by the NIH

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07013435
Lead sponsor
Massachusetts General Hospital
Responsible party
Giselle K. Perez Lougee (Clinical Psychologist, Massachusetts General Hospital) — Principal investigator
First posted
Jun 10, 2025
Start date
Oct 1, 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Aug 2030 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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