CClinicalTrials.gg
CompletedNCT03981666SLEEP-4-ALLUpdated Aug 19, 2026

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

An interventional study of Questionnaires in Insomnia, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2018, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
177
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

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In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 177 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
177 participants (actual)

Study arms

  • Experimental
    Patients with insomnia

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

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

    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.

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What researchers measure

Primary outcomes

  1. Acceptance rate of self-screening for insomnia

    Time frame: Up to 8 weeks

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Study locations

1 site
  • Gustave Roussy
    Villejuif, Val de Marne 94805, France
08

References and documents

Publications

  • Boinon D, Charles C, Fasse L, Journiac J, Pallubicki G, Lamore K, Ninot G, Guerdoux-Ninot E, Gouy S, Albiges L, Delaloge S, Malka D, Planchard D, Savard J, Dauchy S. Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study. Support Care Cancer. 2021 Oct;29(10):5883-5894. doi: 10.1007/s00520-021-06151-7. Epub 2021 Mar 24. PubMed 33761001 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03981666
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Jun 11, 2019
Start date
May 4, 2018
Primary completion
Jun 29, 2018
Completion
Feb 10, 2019
Last update
Aug 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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