Examining how sleep disturbances affect cognition and quality of life in breast cancer patients
Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Centre Francois Baclesse Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Caen and 1 other locations) |
| Trial ID | NCT05414357 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 39 to 69 years * Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy * 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 * Patient with a primary cancer other than breast 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 this trial is running
Caen and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.