Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer (ICANSLEEP)

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 prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Breast Cancer; Sleep
• Intervention / Treatment: Diagnostic test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carine SEGURA-DJEZZAR, MD; Phone Number: +33 2 31 45 50 02; Email: c.segura.djezzar@baclesse.unicancer.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Centre François Baclesse
    • Contact: Carine SEGURA-DJEZZAR, MD; Phone Number: +33 2 31 45 50 02; Email: c.segura.djezzar@baclesse.unicancer.fr
    • Principal Investigator: Carine SEGURA-DJEZZAR, MD
    • Sub-Investigator: Christelle LEVY, MD
    • Sub-Investigator: George EMILE, MD
    • Sub-Investigator: Adeline MOREL, MD
  • Caen, France, 14000
    • Not yet recruiting
    • Inserm-Ephe-Unicaen U1077
    • Contact: Fausto VIADER, PhD
    • Principal Investigator: Fausto VIADER, PhD
    • Sub-Investigator: Vincent DE LA SAYETTE, PhD
    • Sub-Investigator: Olivier MARTINAUD, PhD
    • Sub-Investigator: Pierre DENISE, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 45 to 65 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with chemotherapy	Diagnostic test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task; Participants complete 3 successive assessments (T1: baseline, T2: at 6 months, T3: after galvanic vestibular stimulation). Assessments include: Functional and Anatomic Magnetic Resonance Imaging at rest and in activation (only at T1 and T2).; Biological and physiological measurements; Spatial memory task; Cognitive battery; Questionnaires (sleep, quality of life); Other Names: Spatial memory task; Cognitive battery; quality of life questionnaires
Active Comparator: Patients without chemotherapy	Diagnostic test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task; Participants complete 3 successive assessments (T1: baseline, T2: at 6 months, T3: after galvanic vestibular stimulation). Assessments include: Functional and Anatomic Magnetic Resonance Imaging at rest and in activation (only at T1 and T2).; Biological and physiological measurements; Spatial memory task; Cognitive battery; Questionnaires (sleep, quality of life); Other Names: Spatial memory task; Cognitive battery; quality of life questionnaires
Active Comparator: cancer-free volunteers	Diagnostic test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task; Participants complete 3 successive assessments (T1: baseline, T2: at 6 months, T3: after galvanic vestibular stimulation). Assessments include: Functional and Anatomic Magnetic Resonance Imaging at rest and in activation (only at T1 and T2).; Biological and physiological measurements; Spatial memory task; Cognitive battery; Questionnaires (sleep, quality of life); Other Names: Spatial memory task; Cognitive battery; quality of life questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of total sleep time to time spent in bed and the number of awakenings lasting more than one minute measured by polysomnography with actimeter	At 6 months
Amplitude of activity-rest rhythm measured with actimeter	At 6 months
Acrophase of activity-rest rhythm measured with actimeter	At 6 months

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: UMR_S 1077 Inserm-EPHE-Normandie Université

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Sleep Wake Disorders; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2022-A00437-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No