RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Recruiting · NCT06553235 · Interventional (participants receive a specific treatment) · Lead sponsor: Aarhus University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive Behavioral Therapy for Insomnia (CBT-I)Sleep hygiene education
What this trial is about
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 can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Aarhus University Hospital - Aarhus N, Denmark