Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

Mass General Brigham

Status: Not yet enrolling

Conditions: Lymphoma

Treatments: Other: SMART3RP-Lymphoma; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07014293

RSGHE-24-1325325-01-CTPS (Other Grant/Funding Number)

25-161

Details and patient eligibility

About

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.

Full 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?

Enrollment: 254 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking adult (18 years or older at enrollment)
• Within 5 years of completing active, curative treatment for lymphoma (includes surgery, chemo-/immuno-/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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups

Enhanced Usual Care

Other group

Description:

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.

Treatment:

Other: Enhanced Usual Care

SMART3RP-Lymphoma

Experimental group

Description:

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.

Treatment:

Other: SMART3RP-Lymphoma