The Experience of Having Chronic Graft-Versus-Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD
研究概览
简要总结
Primary Objectives:
- To explore the experience of chronic graft-versus-host disease (cGVHD) following allogeneic blood or marrow transplantation from the perspective of the patient and the patient's primary family caregiver.
- To develop and validate an instrument to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients who have cGVHD.
Secondary Objectives:
- To develop a detailed description of the experience of having cGVHD.
- To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD.
- To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education.
- To develop a detailed description of caring for a patient with cGVHD.
详细描述
For Patient:
If you agree to take part in this study, you will be asked to take part in 1 interview. During the interview, you will be asked to describe what it has been like for you to have chronic GVHD. In addition, if you agree to take part in this study, your family caregiver, if you have one, will be approached to take part in the study.
For Caregiver:
If you agree to take part in this study, you will be asked to take part in 1 interview. During the interview, you will be asked to describe what it has been like for you to help care for a family member with chronic GVHD.
Both Parties:
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Ability to speak and read English
- •Clinical or histological diagnosis of active cGVHD or at least 3 months post allogeneic BMT without a diagnosis of active GVHD (PATIENT ONLY)
- •Identification as the single primary family caregiver by a patient with cGVHD (CAREGIVER ONLY)
- •Physician or nurse with at least 5 years experience caring for patients with cGHVD (PROFESSIONAL EXPERT ONLY)
- •At least one publication in the last 5 years dealing with cGVHD (PHYSICIAN PROFESSIONAL EXPERT ONLY)
- •Consent to participate
排除标准
- •Inability to understand the intent of the study
- •Medical condition that would preclude participation in an interview lasting 30 minutes (PHASE 1 OF STUDY ONLY)
- •Diagnosis of active psychosis or severe cognitive impairment
- •Bone marrow or stem cell donor for patient (CAREGIVER ONLY)
- •Disease for which BMT was performed not in remission (PATIENT ONLY)
结局指标
主要结局
Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD
时间窗: At time of treatment, duration approximately 30 minutes
次要结局
未报告次要终点