Clinical trial · Interventional
Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia
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
NCT05977062CI-TRIAL-00107339Sleep-4-All-2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Online questionnaires | Other | — | UNRESOLVED |
| Phone call | Other | — | UNRESOLVED |
| Self screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Coaching arm
- interventionNames
- Other: Self screening
- Other: Phone call
- Other: Online questionnaires
Primary outcomes (3)
- measure
- Evolution of the ISI score
- timeFrame
- until 24 weeks after enrolment
- description
- 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.
- measure
- Patient insomnia perception
- timeFrame
- until 24 weeks after enrolment
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.