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Completed
NCT03981666
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
Conditions: Insomnia
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 177
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Location: Gustave Roussy Villejuif Val de Marne
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Adults outpatients at Gustave Roussy,
2. with a breast, colorectal, pulmonary or urological,
3. localized or metastatic cancer,
4. during or after their treatment,
5. able to readily read and understand French,
6. able to use informatic tools confidently and with Internet access at home,
7. who have signed a written informed consent form prior to any study specific procedures,
8. affiliated to a social security system or beneficiary of the same.
Exclusion Criteria:
1. Age \> 85 years old,
2. patient receiving a cancer diagnostic during a consultation of announcement
3. with a WHO index of 3 or 4
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)
5. simultaneous participation in another study of the same type
6. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Source: ClinicalTrials.gov (NCT03981666). StuddyBuddy aggregates publicly available trial information.