search
Back to results

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

Primary Purpose

Breast Cancer, Sleep, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Magnetic Resonance Imaging at rest and in activation with attentional task
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centre François BaclesseRecruiting
  • Inserm-Ephe-Unicaen U1077

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Patients with chemotherapy

Patients without chemotherapy

cancer-free volunteers

Arm Description

Outcomes

Primary Outcome Measures

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
Amplitude of activity-rest rhythm measured with actimeter
Acrophase of activity-rest rhythm measured with actimeter

Secondary Outcome Measures

Full Information

First Posted
May 30, 2022
Last Updated
May 17, 2023
Sponsor
Centre Francois Baclesse
Collaborators
UMR_S 1077 Inserm-EPHE-Normandie Université
search

1. Study Identification

Unique Protocol Identification Number
NCT05414357
Brief Title
Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer
Acronym
ICANSLEEP
Official Title
Impact of Sleep Disturbance on Cognition and Quality of Life in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
UMR_S 1077 Inserm-EPHE-Normandie Université

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sleep, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with chemotherapy
Arm Type
Experimental
Arm Title
Patients without chemotherapy
Arm Type
Active Comparator
Arm Title
cancer-free volunteers
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional Magnetic Resonance Imaging at rest and in activation with attentional task
Other Intervention Name(s)
Spatial memory task, Cognitive battery, quality of life questionnaires
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Time Frame
At 6 months
Title
Amplitude of activity-rest rhythm measured with actimeter
Time Frame
At 6 months
Title
Acrophase of activity-rest rhythm measured with actimeter
Time Frame
At 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine SEGURA-DJEZZAR, MD
Phone
+33 2 31 45 50 02
Email
c.segura.djezzar@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine SEGURA-DJEZZAR, MD
Phone
+33 2 31 45 50 02
Email
c.segura.djezzar@baclesse.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Carine SEGURA-DJEZZAR, MD
First Name & Middle Initial & Last Name & Degree
Christelle LEVY, MD
First Name & Middle Initial & Last Name & Degree
George EMILE, MD
First Name & Middle Initial & Last Name & Degree
Adeline MOREL, MD
Facility Name
Inserm-Ephe-Unicaen U1077
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fausto VIADER, PhD
First Name & Middle Initial & Last Name & Degree
Fausto VIADER, PhD
First Name & Middle Initial & Last Name & Degree
Vincent DE LA SAYETTE, PhD
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, PhD
First Name & Middle Initial & Last Name & Degree
Pierre DENISE, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs