Status:
RECRUITING
Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
UMR_S 1077 Inserm-EPHE-Normandie Université
Conditions:
Breast Cancer
Sleep
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalenc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05414357
Start Date
March 20 2023
End Date
September 1 2027
Last Update
September 22 2025
Active Locations (2)
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1
Centre François Baclesse
Caen, France, 14000
2
Inserm-Ephe-Unicaen U1077
Caen, France, 14000