Cancer, Insomnia
Conditions
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)
Interventions
OTHERSelf screening
Score ISI (Index de Sévérité de l'Insomnie)
OTHERPhone call
Phone call at the beginning of the program and at the middle and at the end.
To be completed at week 1, 6, 12 and 24.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Contacts
STUDY_CHAIRDiane BOINON, MD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed