Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 3
- 主要终点
- Quality of Life (QoL): Change in PROMIS-29
研究概览
简要总结
The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.
详细描述
The Stress Management and Relaxation Response Resiliency Program for lymphoma survivors (SMART3RP-Lymphoma) was adapted by researchers at the MGH. This group program seeks to buffer stress and promote psychological resiliency and physical well-being through a variety of mind-body approaches, such as imagery, relaxation, and yoga, cognitive behavioral strategies, and positive psychology tools.
The main questions it aims to answer are:
- Will survivors randomized to SMART3RP-Lymphoma demonstrate greater improvements in quality of life when compared to survivors randomized to a Health Education Program?
- Will improvements in resiliency lead to improvements in quality of life?
To answer these questions, researchers will compare a resilience intervention tailored to the needs of lymphoma survivors (SMART3RP-Lymphoma) to a Health Education Program to see how they affect quality of life of lymphoma survivors.
Participants will:
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 or Spanish speaking adults (18+ at time of enrollment)
- Within 1-5 years of completing active treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other); individuals may be on maintenance treatment.
排除标准
- Active psychiatric, medical concern or cognitive comorbidity as determined by the site PI or treating clinician
研究组 & 干预措施
Health Education Program
Participants will participate in 8 weekly sessions.
Components include:
- education on the co-occurrence of mental and physical problems
- goal setting for health behavior change
- self-monitoring
HEP is an active control condition for mind body programs and is structurally equivalent to SMART3RP
干预措施: Health Education Program (Other)
SMART3RP-Lymphoma
Participants will participate in 8 weekly sessions.
The intervention components include:
- Eliciting the relaxation response (RR),
- CBT strategies to improve stress management
- Positive psychology strategies to achieve growth enhancement
干预措施: SMART3RP-Lymphoma (Other)
结局指标
主要结局
Quality of Life (QoL): Change in PROMIS-29
时间窗: From enrollment to 6 month follow up
To examine the effects of the SMART3RP-Lymphoma vs. a Health Education Program (HEP) in improving quality of life in early posttreatment lymphoma survivors. Quality of life will be measured using the PROMIS-29 which assesses physical, functional, emotional, and social quality of life. Each survey item is measured on a 1-5 scale. The unit of measurement is a score on a scale.
次要结局
- Resilience: Change in Scores on the Current Experiences Scale (CES)(Enrollment to 3 month follow up)
研究者
Giselle K. Perez Lougee
Clinical Psychologist
Massachusetts General Hospital
研究点 (3)
标识符
- NCT 编号
- NCT07013435
- 其他研究编号
- 25-204
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (2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
- 是
- 是否有结果
- 否
de-identified information as required by the NIH