InsomniaSLEEP-4-ALLNCT03981666
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors
A study testing Questionnaires in people with Insomnia, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2018to 10 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Questionnaires
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with insomnia | Experimental | adult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of self-screening for insomnia
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start4 May 2018
- Primary completion29 Jun 2018
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981666
- Sponsor's protocol ID
- 2018-A00260-55
- Other IDs
- 2017/2659
- Acronym
- SLEEP-4-ALL
- Status last verified
- Aug 2026
- First submitted
- 7 Jun 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03981666
- Acronym / sponsor ID
- SLEEP-4-ALL / 2018-A00260-55
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with insomnia | Experimental | Other: Questionnairesadult outpatients with a localized or metastatic breast, colorectal, pulmonary or urological cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesTo 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. | Other | Patients with insomnia |
Primary outcome
Acceptance rate of self-screening for insomnia
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Results publication: PubMed 33761001Boinon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Insomnia, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate of self-screening for insomnia (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.