Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician
- •Unwilling or unable to participate using telehealth platform
研究组 & 干预措施
SMART3RP-Lymphoma
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.
干预措施: SMART3RP-Lymphoma (Other)
Enhanced Usual Care
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.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
Change from Baseline in Coping Scores on the Measure of Current Status Scale (MOCS-A)
时间窗: Baseline to 3 month follow up
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.
次要结局
- Change in Emotional Distress (anxiety and depression) based on the PROMIS-Anxiety 8a and PROMIS-Depression 8a(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 scores (Functional Assessment of Cancer Therapy (FACT-G))(Enrollment to 3 month follow up)
- Change in Resilience scores (Current Experiences Scale (CES-23))(Enrollment to 3 month follow up)
研究者
Giselle K. Perez Lougee
Clinical Psychologist
Massachusetts General Hospital