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

Gustave Roussy, Cancer Campus, Grand Paris322 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

322

Conditions

Cancer Insomnia

Interventions

Self screeningOTHER

Score ISI (Index de Sévérité de l'Insomnie)

Phone callOTHER

Phone call at the beginning of the program and at the middle and at the end.

Online questionnairesOTHER

To be completed at week 1, 6, 12 and 24.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Centre Léon Bérard

Lyon, France

Institut de Cancérologie de Montpellier

Montpellier, France

Gustave Roussy

Villejuif, France

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: until 24 weeks after enrolment

Data from ClinicalTrials.gov

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