Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

NCT07014293 | Not Yet Recruiting

• 2 other identifiers: 25-161RSGHE-24-1325325-01-CTPS
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Keywords

coping; psychosocial intervention; survivorship; resilience

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 3 month follow up

Secondary Outcomes (6)

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

  Enrollment to 3 month follow up

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

  Enrollment to 3 month follow up

• Change in Physical Health (PROMIS Physical Function-8b)

  Enrollment to 3 month follow up

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

  Enrollment to 3 month follow up

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

  Enrollment to 3 month follow up

Study Arms (2)

Enhanced Usual Care

OTHER

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

SMART3RP-Lymphoma

EXPERIMENTAL

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

Interventions

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.

SMART3RP-Lymphoma

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.

Enhanced Usual Care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician
• Unwilling or unable to participate using telehealth platform

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Mass General Brigham

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: April 15, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)