Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
ConditionLymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician
Unwilling or unable to participate using telehealth platform
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Usual Care
Other interventionParticipants 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.
SMART3RP-Lymphoma
Other interventionThe 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 groups
254 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual CareOther 1 intervention
Group B: SMART3RP-LymphomaExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to 3 month follow upSecondary outcomes
1
Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)
The Generalized Anxiety Disorder Scale-7 (GAD-7) is a 7-item self-report measure assessing symptoms of anxiety. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.
Time frame
Enrollment to 3 month follow up2
Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing symptoms of depression. Items are rated on a 0 to 3 scale and summed to produce a total score ranging from 0 to 24. Higher scores indicate greater depressive symptom severity.
Time frame
Enrollment to 3 month follow up3
Change in Physical Health (PROMIS Physical Function-8b)
The PROMIS Physical Function-8b is an 8-item measure that assesses the ability to perform daily living activities. Each item is scored on a scale of 1 (Unable to do) to 5 (Without any difficulty).
Time frame
Enrollment to 3 month follow up4
Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)
The Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item self-report measure assessing overall quality of life across four domains: physical well-being, functional well-being, emotional well-being, and social/family well-being. Items are rated on a 0 (not at all) to 4 (very much) scale and summed to produce a total score ranging from 0 to 108. Higher scores indicate better quality of life.
Time frame
Enrollment to 3 month follow upSponsors and contacts
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Source ClinicalTrials.gov
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