Improving sleep and cognitive function in breast cancer survivors using an app
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
This study is testing whether an app that helps with sleep can improve thinking skills in breast cancer survivors who have trouble sleeping.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT06553235 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an app-based cognitive behavioral therapy for insomnia (CBT-I) in improving cognitive impairment among breast cancer survivors who experience insomnia. Participants will be randomly assigned to either the CBT-I intervention or an active control group receiving sleep hygiene education. The study will assess cognitive function and insomnia severity through standardized tests and follow participants for six months post-treatment. Additionally, it will explore potential changes in brain structure and inflammation related to the interventions.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18 and older who have completed treatment within the last 1-5 years and experience insomnia and cognitive impairment.
Not a fit: Patients with other sleep disorders, neurodegenerative or psychiatric conditions, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for breast cancer survivors by alleviating insomnia and improving cognitive function.
How similar studies have performed: Previous studies have shown promise in using cognitive behavioral therapy for insomnia, suggesting potential success for this app-based approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Ali Amidi
- Email: ali@psy.au.dk
- Phone: +4587165305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.