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RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention

RecruitingNAAges 18 Years - anyFemaleAarhus University Hospital
NCT06553235 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed) * Insomnia: a score of \>10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder * Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or \<54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale Exclusion Criteria: * Other sleep disorders than insomnia that may confound sleep and/or cognitive function * Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed) * Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function * Shift work * Pregnancy or maternity leave * Recurrence of BC or new cancer * Insufficient Danish proficiency * Substance abuse that may confound sleep and/or cognitive function * Previous experience with CBT-I * Other cancer than breast cancer
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What it tests

  • Cognitive Behavioral Therapy for Insomnia (CBT-I)
  • Sleep hygiene education
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Where

1 site
Aarhus University Hospital
Aarhus N, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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