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Trial Title:
Optimization of an Online Stepwise Therapeutic Device Based on a Cognitive-behavioral Approach for Cancer Patients With Insomnia
NCT ID:
NCT05977062
Condition:
Cancer
Insomnia
Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Self screening
Description:
Score ISI (Index de Sévérité de l'Insomnie)
Arm group label:
Coaching arm
Intervention type:
Other
Intervention name:
Phone call
Description:
Phone call at the beginning of the program and at the middle and at the end.
Arm group label:
Coaching arm
Intervention type:
Other
Intervention name:
Online questionnaires
Description:
To be completed at week 1, 6, 12 and 24.
Arm group label:
Coaching arm
Summary:
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)
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Institut de Cancérologie de Montpellier
Address:
City:
Montpellier
Zip:
34090
Country:
France
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Start date:
February 25, 2022
Completion date:
October 13, 2024
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977062
