Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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

Первичные конечные точки

• Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A) [Срок оценки: Baseline to 3 month follow up]

Вторичные конечные точки (6)

• Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7) [Срок оценки: Enrollment to 3 month follow up]
• Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: Enrollment to 3 month follow up]
• Change in Physical Health (PROMIS Physical Function-8b) [Срок оценки: Enrollment to 3 month follow up]
• Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G) [Срок оценки: Enrollment to 3 month follow up]
• Change in Quality of Life Based on the PROMIS Global-10 [Срок оценки: Enrollment to 3 month follow up]
• Change in Resilience scores (Current Experiences Scale (CES-23)) [Срок оценки: Enrollment to 3 month follow up]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mass General Brigham — Boston

Идентификаторы

NCT: NCT07014293 · 25-161 · RSGHE-24-1325325-01-CTPS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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