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

Not Applicable

Active, not recruiting

• Conditions: Insomnia; Cancer
• Interventions: Other: Self screening; Other: Phone call; Other: Online questionnaires

• Registration Number: NCT05977062
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Study First Submitted: 2023-05-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2023-10-13
• Study Completion: 2024-10-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 322

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coaching arm	Self screening	-
Coaching arm	Phone call	-
Coaching arm	Online questionnaires	-

Primary Outcome Measures

Name	Time	Method
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.
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).
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).

Trial Locations

Locations (3)

Gustave Roussy; 🇫🇷 Villejuif, France

Institut de Cancérologie de Montpellier; 🇫🇷 Montpellier, France

Centre Léon Bérard; 🇫🇷 Lyon, France