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
- 1
- 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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 单盲 (研究者)
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)
- Is at least 6 months post-diagnosis and a) is currently undergoing lymphoma treatment (includes surgery, chemotherapy/immunotherapy/radiation therapy, or other) with evidence of treatment response or disease control; or b) has completed lymphoma treatment (e.g., chemotherapy/immunotherapy/radiation therapy, surgery or other) within the past 2 years and has disease control at treatment completion; patients may still be on maintenance treatment to prolong disease control.
排除标准
- Has not initiated treatment for lymphoma.
- Has worsening, progressive, or uncontrolled disease that is not responding to treatment.
- Active Psychiatric, medical 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
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)
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)
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 Physical Health (PROMIS Physical Function-8b)(Enrollment to 3 month follow up)
- Change in Resilience scores (Current Experiences Scale (CES-23))(Enrollment to 3 month follow up)
- Change in Anxiety Symptoms Based on the Generalized Anxiety Disorder Scale-7 (GAD-7)(Enrollment to 3 month follow up)
- Change in Depressive Symptoms Based on the Patient Health Questionnaire-8 (PHQ-8)(Enrollment to 3 month follow up)
- Change in Quality of Life Based on the Functional Assessment of Cancer Therapy-General (FACT-G)(Enrollment to 3 month follow up)
- Change in Quality of Life Based on the PROMIS Global-10(Enrollment to 3 month follow up)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07014293
- 其他研究编号
- 25-161, RSGHE-24-1325325-01-CTPS
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (3年后)
- 研究完成日期
- (3年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否