Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- Feasibility of STEPP
研究概览
简要总结
The main purpose of this study is to determine if a novel peer support intervention (STEPP) is feasible among patients undergoing hematopoietic stem cell transplantation (HSCT).
The name of the intervention used in this research study is STEPP, a peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.
详细描述
The goal of this project is to refine a peer support intervention (STEPP) for patients undergoing hematopoietic stem cell transplantation (HSCT) and to conduct a randomized clinical trial to test its feasibility and preliminary efficacy for improving quality of life (QOL) and reducing psychological distress.
Participants will be randomized into one of two study groups: Peer Support Intervention (STEPP) vs. Usual Care. Randomization means a participant is placed into a group by chance. Participants will have an equal chance of being placed in either group.
Study procedures include screening for eligibility and questionnaires.
Participation in this study is expected to last about 10 weeks.
It is expected that about 80 people will participate in this randomized clinical trial.
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
- None
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
- •Adult patients (age > 18 years) with a hematologic malignancy undergoing autologous or allogeneic HSCT.
- •Ability to comprehend, read, and respond to questions in English as STEPP is only available in English.
排除标准
- •Patients undergoing HSCT for benign hematologic conditions.
- •Patients undergoing outpatient HSCT.
- •Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
- •Patients undergoing HSCT for the second time.
结局指标
主要结局
Feasibility of STEPP
时间窗: Up to 10 weeks
The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.
次要结局
- Acceptability of STEPP(Up to Day +60 (+/- 10 days))
- Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)(Up to Day +60 (+/- 10 days))
- Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)(Up to Day +60 (+/- 10 days))
- Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)(Up to Day +60 (+/- 10 days))
- Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)(Up to Day +60 (+/- 10 days))
- Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)(Up to Day +60 (+/- 10 days))
研究者
Hermioni L.Amonoo, MD, MPP, MPH
Director, Well-Being and Cancer Research Program
Brigham and Women's Hospital