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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education

BEHAVIORAL

Sleep hygiene education

\- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.

Locations (1)

Aarhus University Hospital
Aarhus N, Denmark