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

NCT07013435 | Not Yet Recruiting

• 1 other identifier: 25-204
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma

Keywords

quality of life; psychosocial intervention; supportive care; cancer survivorship; resilience

Outcome Measures

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.

  From enrollment to 6 month follow up

Secondary Outcomes (1)

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

  Enrollment to 3 month follow up

Other Outcomes (1)

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

  3, 6 and 12 months

Study Arms (2)

Health Education Program

ACTIVE COMPARATOR

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

SMART3RP-Lymphoma

EXPERIMENTAL

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

Health Education Program OTHER

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.

Health Education Program

SMART3RP-Lymphoma OTHER

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.

SMART3RP-Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 30, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Information will be made available as required by the NIH in public repository and via clinicaltrials.gov
• Access Criteria: Researchers submitting formal requests as required and allowable by the NIH will be able to access supporting information.

Locations

US (1)