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

Cancer Clinical Trial

— Sleep-4-All-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05977062
• Other study ID #: 2021-A01891-40
• Secondary ID: 2021/3317
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: October 13, 2024

Study information

• Verified date: July 2023
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 322
• Est. completion date: October 13, 2024
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Self screening
Score ISI (Index de Sévérité de l'Insomnie)
• Phone call
Phone call at the beginning of the program and at the middle and at the end.
• Online questionnaires
To be completed at week 1, 6, 12 and 24.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon
France	Institut de Cancérologie de Montpellier	Montpellier
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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