A Prospective Randomized Trial of Interactive Telemonitoring in the Follow-up of Patients Treated for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 765
- 主要终点
- Patient preference for follow-up modality
研究概览
简要总结
Patients with early breast cancer were randomized at the final visit of adjuvant radiotherapy to surveillance by phone calls or by mobile Noona software. After six months the groups were crossed over to the other arm. At 12 months the patients were asked their preference which was the primary end-point. At baseline, 6 months and 12 months the patients answered the other questionnaires.
详细描述
Patients with early breast cancer were randomized at the final visit of adjuvant radiotherapy to surveillance by phone calls or by mobile Noona software. After six months the groups were crossed over to the other arm.
The primary end point was to find out patient preference for the modality of surveillance. Secondary endpoints were patient satisfaction, symptoms, quality of life and cost of follow-up during surveillance modalities.
At 12 months the patients were asked their preference for the follow-up modality of early breast cancer. At baseline, 6 months and 12 months the patients answered the other questionnaires on quality of life, symptoms, patient satisfaction and use of other health-care services. Information on the cost of follow-up was gathered from the hospital and other registries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Adult patients with early breast cancer after primary treatment including also radiotherapy (the patients were randomized at the final visit of radiotherapy)
排除标准
- •not able to use a computer
- •another malignancy
研究组 & 干预措施
Mobile software
Patient with early breast cancer were followed-up by mobile software for the first six months. At six months they crossed-over to be followed-up by telephone calls for the next six months.
干预措施: Mobile software for follow-up of early breast cancer (Device)
Telephone calls
Patient with early breast cancer were followed-up by telephone calls for the first six months. At six months they crossed-over to be followed-up by mobile software for the next six months.
干预措施: Mobile software for follow-up of early breast cancer (Device)
结局指标
主要结局
Patient preference for follow-up modality
时间窗: At 12 months during follow-up of early breast cancer
Questionnaire of patient preference
次要结局
- Quality of life during follow-up modality(At baseline, 6 months and 12 months)
- Patient satisfaction(At 6 months and 12 months)
- Symptoms(At baseline, 6 months and 12 months)
- Use of other healthcare services(At 6 months and 12 months)
研究者
Johanna Mattson
Physician-in-Chief
Helsinki University Central Hospital