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Completed

NCT Number: NCT05977062

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

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)

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Key information

Conditions

Cancer Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self screening

Other

Score ISI (Index de Sévérité de l'Insomnie)

phone call

Other

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

online questionnaires

Other

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: Sleep-4-All-2

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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