Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia (Sleep-4-All-2)

March 31, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre Leon Berard
      • Montpellier, France, 34090
        • Institut de Cancérologie de Montpellier
      • Villejuif, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Study Chair: Diane BOINON, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

July 8, 2025

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01891-40
  • 2021/3317 (Other Identifier: CSET number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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