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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy

Villejuif, Val De Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Acceptance rate of self-screening for insomnia

Time frame: Up to 8 weeks

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: SLEEP-4-ALL

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Jun 11, 2019
Registry last updated: Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed