PRO-COM Project: Randomized-controlled Study Evaluating the Impact of Electronic Patient Reported Outcome (ePRO) Surveys on Patient-physician Communication and Quality of Life in Patients With Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Patient-physician communication
研究概览
简要总结
PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IV breast cancer
- •Start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit
- •Estimated life expectancy of minimum six months
- •Signed informed consent
- •No cognitive or speech impairments
排除标准
- 未提供
研究组 & 干预措施
Intervention Arm
Quality of life questionnaires (electronic patient reported outcomes) to be filled out by the patients at every visit. Quality of life data is fully available for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months.
干预措施: Questionnaires (Other)
Control Arm
Quality of life questionnaires (electronic patient reported outcomes) only to filled out by the patients at baseline, after three months and after six months. Quality of life data is hidden for physicians. Paper-based questionnaire (EORTC QLQ-COMU26) at baseline, after three months and after six months.
干预措施: Questionnaires (Other)
结局指标
主要结局
Patient-physician communication
时间窗: Up to six months
The communication between patient and physician will be assessed with EORTC QLQ-COMU26. Presumably some patients have privacy concerns with electronic questionnaires. The EORTC-COMU26 is the most important questionnaire in this study because it is needed for the primary endpoint. It contains sensitive questions about how the patient experiences the communication during the visit. In order to avoid patients not filling out the questionnaire due to privacy concerns or being afraid of giving an honest opinion and the physician could read it electronically, the EORTC QLQ-COMU26 is paper-based and the patients can hand them in in the study office.
次要结局
- Quality of life assessment(Arm A: at every visit for six months; Arm B: at baseline, three months, six months)
- Frequency of discontinuations of therapy(Up to six months)
- Duration of communication between physician and patient(At baseline, three months, six months in both groups)
研究者
Dr. Vera Trommet
Principal Investigator
Klinikum Wels-Grieskirchen