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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 348
- Locations
- 6
- Primary Endpoint
- Evolution of the ISI score
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Coaching arm
Intervention: Self screening (Other)
Coaching arm
Intervention: Phone call (Other)
Coaching arm
Intervention: Online questionnaires (Other)
Outcomes
Primary Outcomes
Evolution of the ISI score
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported