Sleep-4-all-2.0 Study: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia - A Prospective Real-life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 6
- 主要终点
- Evolution of the ISI score
研究概览
简要总结
Determine who can benefit from additional follow-up by a professional and what type of help is most appropriate (need and expectation of patients in terms of support by a health professional)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients,
- •With a diagnosis of localized or metastatic cancer,
- •During or after their treatment,
- •In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier Cancer Institute (Montpellier), and Léon Bérard Center (Lyon)
- •With a significative score on the self-screening Insomnia Severity Index score (ISI ≥ 8)
- •Able to readily read and understand French,
- •Able to use informatic tools confidently and with Internet access,
- •Who have signed the online consent form,
- •Affiliated to a social security system or beneficiary of the same.
排除标准
- •Patient with a visual, hearing or cognitive disability that is incompatible with the study,
- •Simultaneous participation in another study evaluating a treatment of insomnia,
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
研究组 & 干预措施
Coaching arm
干预措施: Self screening (Other)
Coaching arm
干预措施: Phone call (Other)
Coaching arm
干预措施: Online questionnaires (Other)
结局指标
主要结局
Evolution of the ISI score
时间窗: until 24 weeks after enrolment
The primary outcome is to evaluate the evolution of the ISI score of patients with score \> 8. ISI = Index de Sévérité de l'Insomnie. Score \> 8 means the patient has insomnia issue.
Adherence to the intervention
时间窗: until 24 weeks after enrolment
The frequency and the evolution of connections (A/globally, namely total number of connections per week and during all the intervention; B/potential differences in the frequency of connections throughout the weeks); * the type and proportion of components effectively consulted (videos, modules, and tools); * the duration of the use of the study web platform (total number of weeks).
Patient insomnia perception
时间窗: until 24 weeks after enrolment
Two ad-hoc items will be proposed to the participants to determine if insomnia is considered as a problem for them (outcome perception), and as a problem important to solve (outcome expectancy).
次要结局
未报告次要终点