Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
研究概览
简要总结
The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
详细描述
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease.
Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care.
Participation in this study is expected to last up to 18 weeks after enrollment.
The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.
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 (≥ 18 years) who have undergone allogeneic HCT
- •Have moderate to severe cGVHD based on patient-report
- •Have ability to participate in English or Spanish language group telehealth intervention.
排除标准
- •Patients with mild cGVHD based on their self-report.
- •Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
- •Patients with active relapsed disease requiring therapy.
研究组 & 干预措施
HORIZONS intervention
Participants randomized to HORIZONS plus usual care will complete the following:
- Questionnaires at baseline, and weeks 10 and 18
- Receive the HORIZONS intervention from enrollment and for up to 8 weeks. HORIZONS is an 8-session multidisciplinary, patient-centered intervention that combines medical and psychosocial expertise to enhance self-management and quality of life.
- Receive usual care as determined by their local clinicians
干预措施: HORIZONS Intervention (Behavioral)
Minimally enhanced usual care
Participants randomized to usual care will complete the following
- Questionnaires at baseline, and weeks 10 and 18 after enrollment
- Receive a standardized booklet containing evidence-based information on chronic GVHD management and HCT survivorship recommendations as well as receive care as determined by their local oncologists
干预措施: Minimally enhanced usual care (Behavioral)
结局指标
主要结局
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
时间窗: At 10 weeks post-enrollment
Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
时间窗: 10 weeks
Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
次要结局
- Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)(At 10 weeks post enrollment)
- Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Anxiety)(At 10 weeks post enrollment)
- Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale(At 10 weeks post enrollment)
- Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire(Up to 18 weeks post enrollment)
- Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)(Up to 18 weeks post enrollment)
- Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)(Up to 18 weeks post enrollment)
- Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale(Up to 18 weeks post enrollment)
研究者
El-Jawahri, Areej,M.D.
Professor of Medicine
Massachusetts General Hospital