Improving sleep and cognitive function in breast cancer survivors using an app

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting

Study contacts

• Study coordinator: Ali Amidi
• Email: ali@psy.au.dk
• Phone: +4587165305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.