Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
研究概览
简要总结
Monocentric, prospective cohort pilot study evaluating the feasibility of a online remote monitoring tool during the care of patients over 65 years of age being medically treated for cancer.
详细描述
Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required).
In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.
At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years of age and over.
- •Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
- •Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
- •Informed consent dated and signed.
- •Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health).
排除标准
- •Life expectancy less than 12 months.
- •Patient declining to use a tablet, computer, mobile phone or the Internet.
- •Patient not knowing how to read and understand French.
- •Technical impossibility of connecting to the Internet in the patient's living area.
- •5. Patient already included in this study or in another study evaluating a remote monitoring system.
研究组 & 干预措施
Remote monitoring for elderly patients with cancer
干预措施: Remote monitoring (Other)
结局指标
主要结局
Proportion of Patients Who Completed at Least All of 9 Questionnaires at 3 Months
时间窗: 3 months
The primary endpoint is the proportion of patients who completed at least all of the following questionnaires at 3 months (9 questionnaires in total): * 6 weekly questionnaires on toxicities and clinical symptoms completed within 3 months of the start of treatment: Toxicities and clinical symptoms will be assessed through 20 questions selected and adapted from the French version of the PRO (patient-reported outcomes) of the CTCAE (Common Terminology Criteria for Adverse Events); * 2 questionnaires assessing the health-related quality of life, completed before the start of treatment and at 3 months: Quality of life will be assessed using the EORTC QLQ-C30 questionnaire comprising 30 items. The targeted dimensions of the QLQ-C30 will be the five functional scales (physical, daily activity, emotional, cognitive and social) and the overall quality of life scale; * The questionnaire evaluating the perceived benefit of the treatment at 3 months.
次要结局
- Number of Toxicities and Clinical Symptoms Reported by Patients Triggering a "Red" Alert.(Weekly during 6 months)
- Rate of Patients With Perceived Benefit of Treatment.(3 months and 6 months)
- Rate of Patients With Satisfaction With the Use of the Remote Monitoring Tool(3 months and 6 months)
- Quality of Life (EORTC QLQ-C30)(3 months and 6 months)
- Depression and Anxiety Using the HAD Questionnaire(3 months and 6 months)
- Number of Unscheduled Hospitalizations> 24 Hours and Emergency Room Visits(6-month follow-up)