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

Study acronym: ICANSLEEP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial arms changed: 3 → 2
    • Eligibility criteria expanded, about 35 words
    • Publications: details revised at 2 of 2 entries
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Minor Eligibility criteria revisedv4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Oct 2022 to Mar 20, 2023
    • Primary completion date: Oct 2026 to Mar 2027
    • Study completion date: Jun 2027 to Sep 2027
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Jun 2022 to Oct 2022v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05414357
Lead Sponsor Centre Francois Baclesse
Collaborators: UMR_S 1077 Inserm-EPHE-Normandie Université
Conditions
(from sponsor)
Breast Cancer, Sleep, Quality of Life
Related terms Breast Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov