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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06529120
Eligibility Criteria:
Inclusion Criteria:
1. stage 0-IV breast cancer diagnosis within past 12 months
2. self-report \>8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
3. \>18 years old
4. life expectancy of \>12 months per medical chart or oncologist
5. Ability to speak and read English, and intact hearing and vision
Exclusion Criteria:
1. reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam \<25;
2. serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy, severe or moderate untreated sleep apnea) indicated by self-report, medical chart, or oncologist/provider that would contraindicate safe participation;
3. engagement in behavioral insomnia (e.g., Cognitive-Behavioral Therapy for Insomnia) or symptom management (e.g., Pain Coping Skills Training) interventions within past 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06529120
Study Brief:
Protocol Section:
NCT06529120