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

Recruiting now · Not applicable

Conditions studied: Insomnia, Cognitive Impairment, Breast Cancer

In brief

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.

Key facts

Study ID

NCT06553235

Run by

Aarhus University Hospital

People needed

84

Starts

2024-12-06

Expected to finish

2030-03-28

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aarhus University Hospital — Aarhus N, Denmark (enrolling)

Full record on ClinicalTrials.gov

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