Status:
RECRUITING
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
University of Aarhus
Conditions:
Insomnia
Cognitive Impairment
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The study is a randomized controlled trial comparing the effect of app-based cognitive behavioral therapy for insomnia (CBT-I) on cognitive function and insomnia to an active control group (sleep hygi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2030
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06553235
Start Date
December 6 2024
End Date
March 28 2030
Last Update
January 8 2025
Active Locations (1)
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1
Aarhus University Hospital
Aarhus N, Denmark