Examining how sleep disturbances affect cognition and quality of life in breast cancer patients
Official title: Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer
Run by Centre Francois Baclesse · NCT05414357 · Data updated 2026-11-12
This study is testing how sleep problems affect thinking and overall well-being in breast cancer patients who have had surgery and are between 39 and 69 years old.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 65 Years |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Caen and 1 other locations) |
| Status | Recruiting |
| Started | March 20, 2023 |
| Main results expected | March 2027 |
| Study ends | September 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT05414357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients aged 39 to 69 with localized breast cancer who are experiencing sleep complaints and have no pre-existing cognitive impairments.
✕Probably not a fit
Patients with metastatic cancer, primary cancers other than breast cancer, or significant neurological or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of sleep disturbances, particularly insomnia, on cognition and quality of life among patients treated for localized breast cancer. It aims to gather objective data on sleep patterns using functional magnetic resonance imaging (fMRI) during rest and while performing attentional tasks. The study will include patients aged 39 to 69 who have undergone surgery for breast cancer and are experiencing sleep complaints. By understanding these relationships, the research seeks to provide insights into the cognitive effects of sleep issues in this population.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for sleep disturbances in breast cancer patients, enhancing their overall quality of life.
How similar studies have gone: While previous studies have explored sleep disturbances in cancer patients, this study's specific focus on breast cancer and the use of fMRI for objective assessment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 39 to 69 years * A patient with localized breast cancer who has undergone surgery and may or may not be about to begin adjuvant treatment with chemotherapy or radiation therapy * Patient with education level 3 "end of primary education" * Patient with a good command of the French language * Patient with access to the Internet from a computer at home * Patient having signed the consent to participate in the study * Patient with no pre-existing cognitive impairment at the time of cancer diagnosis * Patient with a sleep complaint (ISI \> 7) Exclusion Criteria: * Patient with metastatic cancer * A patient with a primary cancer other than breast cancer and/or a history of treated cancer * Patient with a history of neurological damage * Patient with treated sleep apnea * Patient with drug use or alcohol abuse (≥3 drinks/day on average and/or \>10 drinks/week) * Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics) * Patient with a personality disorder and/or an evolving psychiatric pathology * Patient with a contraindication to MRI (claustrophobia, metallic objects in the body) * Patient with an uncorrected vision problem
Where it's running
-
Centre François Baclesse
Caen, France Recruiting -
Inserm-Ephe-Unicaen U1077
Caen, France Not yet recruiting
Study contacts
- Study coordinator: Carine SEGURA-DJEZZAR, MD
- Email: c.segura.djezzar@baclesse.unicancer.fr
- Phone: +33 2 31 45 50 02
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.