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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Other: Questionnaires

• Registration Number: NCT03981666
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-04
• Primary Completion: 2018-06-29
• Study Completion: 2019-02-10
• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-07
• Last Update Submitted: 2019-06-07
• Study First Posted: 2019-06-11
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with insomnia	Questionnaires	adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer

Primary Outcome Measures

Name	Time	Method
Acceptance rate of self-screening for insomnia	Up to 8 weeks

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France