Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced Usual Care, SMART3RP-Lymphoma.
- Who it may be relevant to
- Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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?
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.
Interventions
- Other Enhanced Usual Care
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. - Other SMART3RP-Lymphoma
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 achiev
Primary outcome measures
- Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A) [Time frame: Baseline to 3 month follow up]
Secondary outcome measures (6)
- Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7) [Time frame: Enrollment to 3 month follow up]
- Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8) [Time frame: Enrollment to 3 month follow up]
- Change in Physical Health (PROMIS Physical Function-8b) [Time frame: Enrollment to 3 month follow up]
- Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G) [Time frame: Enrollment to 3 month follow up]
- Change in Quality of Life Based on the PROMIS Global-10 [Time frame: Enrollment to 3 month follow up]
- Change in Resilience scores (Current Experiences Scale (CES-23)) [Time frame: Enrollment to 3 month follow up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mass General Brigham — Boston
Identifiers
NCT: NCT07014293 · 25-161 · RSGHE-24-1325325-01-CTPS