Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Patients With 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
- 120
- 试验地点
- 2
- 主要终点
- Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
研究概览
简要总结
The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)
详细描述
Frequently patients living with chronic GVHD experience physical and emotional symptoms during the course of illness that impacts their quality of life. Patients also often report difficulty managing many of the tasks they need to do to manage their chronic GVHD. They also frequently have a lot of questions about chronic GVHD and the expected trajectory of this illness.
The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, and psychological distress in patients with chronic GVHD
- This study will randomly assign participants to either receiving Horizons plus usual care or usual care alone.
- Enrolled participants will be on the research study for up to sixteen weeks and it is expected that about 120 people will take part in this research study.
The Leukemia and Lymphoma Society is supporting this research by providing funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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 underwent allogeneic hematopoietic stem cell transplant (HCT).
- •Have moderate to severe chronic GVHD based on their oncology clinician assessment as documented in the Electronic Health Record.
- •Ability to comprehend and speak English as the HORIZONs app is only available in English.
排除标准
- •Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
研究组 & 干预措施
Usual Care
Participant in the usual care group will receive usual care from the transplant oncology team including all the supportive care measures implemented by the transplant oncology team.
Participants will complete study questionnaires at the time of enrollment (baseline) nad at eight and sixteen weeks after enrollment
干预措施: Usual Care (Behavioral)
Horizons mobile app
Participants randomly assigned to the Horizons group, will use the Horizons app over an eight-week period in addition to receiving usual care from transplant team.
Participants will complete study questionnaires at the time of enrollment (baseline) and at eight and sixteen weeks after enrollment
干预措施: App (Behavioral)
结局指标
主要结局
Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
时间窗: 8 Weeks
Compare patient QOL (FACT-BMT) between usual care and Horizon at 8 weeks using ANCOVA. FACT-BMT score range 0-164, with higher scores indicating better quality of life.
次要结局
- Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)(up to sixteen weeks)
- Depression symptoms using HADS-Depression(up to sixteen weeks)
- Chronic GVHD symptom burden (Lee Scale)(up to sixteen weeks)
- Quality of life (QOL) longitudinal using FACT-BMT(Up to sixteen weeks)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital