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临床试验/NCT03959774
NCT03959774Unknown不适用

Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment

Institut Paoli-Calmettes4 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2020年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
119
试验地点
4
主要终点
demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.

研究概览

简要总结

adherence of digital follow-up in a population of elderly patients.

详细描述

The use of digital self-questionnaires adapted to elderly patients but also to BrC and Bac could detect the toxicities of chemotherapy and we formulate the hypothesis that the continuous monitoring of these different variables in elderly patients treated with chemotherapy is possible and acceptable to this population.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 70 years,
  • •Patient with an indication of adjuvant chemotherapy showing:
  • •Breast cancer
  • •Colorectal cancer
  • •lung cancer
  • •WHO ≤ 3 (WHO index - World Health Organization)
  • •Estimated life expectancy> 6 months
  • •patients with a smartphone or tablet with an internet connection. It can also be offered to patients whose primary caregiver or the person of trust (including the partner) has a smartphone, an internet connection or a tablet provided that he or she is present more than three times during the week. during chemotherapy to ensure smooth weekly data transfer and filling of questionnaires
  • •Signed consent to participation
  • •Affiliation to, or beneficiary of, a social security scheme

排除标准

  • •Person in emergency situation, person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his / her consent
  • •Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
  • •Contraindications to the procedure of the study: patient or caregiver living with a patient who does not have a smartphone with an internet connection (patient or caregiver living with a patient)
  • •Concurrent participation in another clinical trial
  • •Patient unable to understand the quality of life survey and Patient Reported Outcome

研究组 & 干预措施

breast or colorectal or lung cancer, age 70 or older

Experimental

breast or colorectal or lung cancer, age 70 or older

干预措施: IPC NET (Device)

结局指标

主要结局

demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.

时间窗: 12 months after the last chemotherapy received by the patient

numerical follow-up compliance rate, defined as the rate of patients who observed the following three rules during the entire course of adjuvant chemotherapy: a minimum weight per week, the wearing of the bracelet for three consecutive days per week, and the weekly response to the digital self-questionnaire. Failure to comply with at least one of these rules will be considered a failure.

次要结局

未报告次要终点

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (4)

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