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

NCT03981666 | Completed

• 2 other identifiers: 2018-A00260-552017/2659
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Acceptance rate of self-screening for insomnia

  Up to 8 weeks

Study Arms (1)

Patients with insomnia

EXPERIMENTAL

adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

Patients with insomnia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: May 4, 2018
• Primary Completion: June 29, 2018
• Study Completion: February 10, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

FR (1)