Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
NCT03981666 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177
Last updated 2019-06-11
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.
Conditions
Interventions
- OTHER
-
Questionnaires
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.
Sponsors & Collaborators
-
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-04
- Primary Completion
- 2018-06-29
- Completion
- 2019-02-10
Countries
- France
Study Locations
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