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
- 1
- 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
- •Older than 18 years
- •Speaking, understanding and writing Dutch fluently
- •Mentally competent
- •Recently underwent a operation for breast cancer (invasive or in situ)
- •Takes AET for maximum two months
- •Consultation planned within 4-5 month
- •Home access of a computer with internet connection
排除标准
- •Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
- •Metastatic disease
- •Inclusion Criteria health care professionals:
- •Contact with patient(s) included in the trial
- •Exclusion Criteria health care professionals:
- •Included in panels
- •Member of the research team
研究组 & 干预措施
Control group
Standard of care:
- a short overview of the physician on adjuvant endocrine therapy
- a brochure on adjuvant endocrine therapy
- a voluntary group session on adjuvant endocrine therapy
and a monthly questionnaire on the patient reported outcomes
Intervention group
Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes.
The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation.
干预措施: Co'moon (online website to support women with AET) (Device)
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
- Time-spend on Co'moon(up to 3 months)
- 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)