Sleep-4-All-2: Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia
Study Details
Study Description
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Coaching arm
|
Other: Self screening
Score ISI (Index de Sévérité de l'Insomnie)
Other: Phone call
Phone call at the beginning of the program and at the middle and at the end.
Other: Online questionnaires
To be completed at week 1, 6, 12 and 24.
|
Outcome Measures
Primary Outcome Measures
- Evolution of the ISI score [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.
- Patient insomnia perception [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).
- Adherence to the intervention [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults patients,
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With a diagnosis of localized or metastatic cancer,
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During or after their treatment,
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In one of the following three cancer centres: Gustave Roussy (Villejuif), Montpellier Cancer Institute (Montpellier), and Léon Bérard Center (Lyon)
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With a significative score on the self-screening Insomnia Severity Index score (ISI ≥
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Able to readily read and understand French,
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Able to use informatic tools confidently and with Internet access,
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Who have signed the online consent form,
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Affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
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Patient with a visual, hearing or cognitive disability that is incompatible with the study,
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Simultaneous participation in another study evaluating a treatment of insomnia,
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Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Bérard | Lyon | France | 69008 | |
| 2 | Institut de Cancérologie de Montpellier | Montpellier | France | 34090 | |
| 3 | Gustave Roussy | Villejuif | France | 94805 |
Sponsors and Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
Investigators
- Study Chair: Diane BOINON, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A01891-40
- 2021/3317