Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors (SLEEP-4-ALL)

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Villejuif, Val De Marne, France, 94805
      • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with insomnia; adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acceptance rate of self-screening for insomnia	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2018
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): February 10, 2019

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2018-A00260-55; 2017/2659 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No