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

Insomnia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981666
• Other study ID #: 2018-A00260-55
• Secondary ID: 2017/2659
• Status: Completed
• Phase: N/A
• Start date: May 4, 2018
• Est. completion date: February 10, 2019

Study information

• Verified date: June 2019
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: February 10, 2019
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance rate of self-screening for insomnia		Up to 8 weeks