Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Other: Self screening
* Other: Phone call
* Other: Online questionnaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coaching arm<br> | Other: Self screening<br>* Score ISI (Index de Sévérité de l'Insomnie)<br>Other: Phone call<br>* Phone call at the beginning of the program and at the middle and at the end.<br>Other: Online questionnaires<br>* To be completed at week 1, 6, 12 and 24.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the ISI score | 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. | until 24 weeks after enrolment | 
| Patient insomnia perception | 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). | until 24 weeks after enrolment | 
| Adherence to the intervention | 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). | until 24 weeks after enrolment |