Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rate of retention
研究概览
简要总结
This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).
详细描述
This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding of chronic GVHD and treatment, coping, and quality of life.
Randomization means that participants will be put into one of two groups by chance:
- Horizons Program
--Individuals who receive the Horizons Program will attend 8 weekly 90-minute group sessions using a secure TeleHealth videoconferencing system
- Usual care --Individuals who receive usual care will also receive an educational booklet.
The research study procedures include:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (≥ 21 years) who underwent allogeneic HCT
- •have moderate to severe chronic GVHD
- •are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
- •have the ability to participate in an English language group intervention
排除标准
- •Patients with comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
- •Vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention
结局指标
主要结局
Rate of retention
时间窗: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% of participants remain in study
Rate of Enrollment
时间窗: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of adherence
时间窗: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
次要结局
- Medical Adherence: Medication Adherence Report Scale (MARS-5)(Baseline (pre-randomization) up to 16 week follow up)
- Self-Efficacy: Cancer Self-Efficacy Scale (CASE)(Baseline (pre-randomization) up to 16 week follow up)
- Coping Skills: Measure of Current Status (MOCS)(Baseline (pre-randomization) up to 16 week follow up)
- Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)(Baseline (pre-randomization) up to 16 week follow up)
- Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)(Baseline (pre-randomization) up to 16 week follow up)
- Psychological Distress: Hospital Anxiety and Depression Scale (HADS)(Baseline (pre-randomization) up to 16 week follow up)
- Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)(Baseline (pre-randomization) up to 16 week follow up)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital