Back to resultsVideo-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors (SLEEP-4-ALL)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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.
Sites / Locations
- Gustave Roussy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with insomnia
Arm Description
adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer
Outcomes
Primary Outcome Measures
Acceptance rate of self-screening for insomnia
Secondary Outcome Measures
Full Information
NCT ID
NCT03981666
First Posted
June 7, 2019
Last Updated
June 7, 2019
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT03981666
Brief Title
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
Acronym
SLEEP-4-ALL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2018 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
February 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with insomnia
Arm Type
Experimental
Arm Description
adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptance rate of self-screening for insomnia
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
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