Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change in quality of Life - FACT-ES - B5 - H18
研究概览
简要总结
The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.
详细描述
The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.
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
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in quality of Life - FACT-ES - B5 - H18
时间窗: monthly after two months of AET; up to 3 months
Total score of Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires of endocrine symptoms (FACT-ES) combined with additional questions B5 and H18. A validated questionnaire with a 5-point Likert scale and a total score of 180 (high QoL).
Change in self-efficacy
时间窗: month 3 and 6 or 7 after the start with AET
patient reported impact on the side effects of AET
Therapy adherence
时间窗: monthly after two months of AET; up to 3 months
patient reported intentional or accidental forgot the medication
Questionnaire on patients experience with the patient-physician relationship
时间窗: month 6 or 7 after the start with AET
patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire
Questionnaire on change in patient-relative communication over a period of +/- 3 months
时间窗: month 3 and 6 or 7 after the start with AET
patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire
次要结局
- Patient reported outcomes(Monthly after two months of AET; up to 3 months)
- Questionnaire on the experience of the healthcare professional regarding the summary of PRO's(month 6 or 7 after the start of AET)
- Time-spend on Co'moon(up to 3 months)