Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT - a Two Site Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
A two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed PROM (Lee Symptom Scale) longitudinally with a 12 month follow up in outpatient care in patients post HSCT to assess symptoms of chronic GVHD (n= 30).
详细描述
A prospective, non-randomized, feasibility study examining a systematic approach to symptom management using PROMs with 12 months of follow up in hematological outpatient clinic
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults > 18 years old
- •Approximately 3 months post HSCT (they will be included before HSCT, but the intervention will begin at 3 moths).
- •Patients included needs to be able to manage a computer to receive and respond to collect PRO data.
排除标准
- •Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
研究组 & 干预措施
Symptom management with Lee Symptom Scale
Participants will receive disease specific questionnaires electronically, cGVHD-PRO (Lee Symtpom Scale), one week prior to their scheduled visit in the outpatient clinic. The participants will be asked to answer the questionnaire from home without any involvement from clinicians. Afterwards the PRO data will be used during the scheduled clinical consultations as an instrument to discover symptoms on chronic GVHD and systematically to monitoring symptoms developing over time.
干预措施: Lee Symptom Scala (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Recruiment time frame: 12 months
Number of participants included from eligible participants
Adherence to intervention
时间窗: Intervention time frame: 12 months of follow up
Number of visits completed out of planned visits during intervention
次要结局
- Depression and Anxiety measured with the Hospital Anxiety and Depression Scale(12 months; at baseline (0 months), 6 and 12 months)
- Quality of life measured by the European Organization for Research and Treatment of Cancer - quality of life questionnaire C30 (EORTC-QLQ-C30)(12 months; at baseline (0 months), 6 and 12 months)
- MD Andersons Symptom Inventory (MDASI)(12 months; at baseline (0 months), 6 and 12 months)
- HM-PRO questionaire developed by the 'Scientific Working Group for QoL and Symptoms,' within the European Hematology Association(12 months; at baseline (0 months), 3, 6, 9 and 12 months)
研究者
Mary Jarden
Professor
Rigshospitalet, Denmark