Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors

Study Overview
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Brief Summary
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SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients. The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at Gustave Roussy.

Official Title
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Systematic Self-screening of Insomnia and Proposition of a Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors: A Pilot Study

Conditions
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Insomnia

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults outpatients at Gustave Roussy, with a breast, colorectal, pulmonary or urological, localized or metastatic cancer, during or after their treatment, able to readily read and understand French, able to use informatic tools confidently and with Internet access at home, who have signed a written informed consent form prior to any study specific procedures, affiliated to a social security system or beneficiary of the same. Exclusion Criteria: Age > 85 years old, patient receiving a cancer diagnostic during a consultation of announcement with a WHO index of 3 or 4 severe cognitive impairements or psychiatric disorders which are incompatible with the conditions and the conduct of the study (understanding of the objectives, completion of the questionnaires) simultaneous participation in another study of the same type patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with insomnia<br>adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer | Other: Questionnaires<br>* To patients who have given their consent for the self-screening, the research assistant will propose 3 questionnaires, which will be completed in the waiting room and returned the same day: Ad hoc questionnaire for demographics and medical data; Insomnia Severity Index (ISI, 7 items, Savard et al., 2005); Edmonton Symptom Assessment System (ESAS, 10 items, Visual Analogue Scale, Bruera et al. 1991) assessing comorbidities as pain, dyspnea, anxiety or depression... The ISI scoring will be realized by the research assistant (in the research office) immediately after its completion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance rate of self-screening for insomnia |  | Up to 8 weeks |