Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT06553235
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06553235
Study Brief:
Protocol Section:
NCT06553235