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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT05030792
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age ≥18
* Stage I-III breast cancer
* Reports a negative change in cognitive function since their cancer diagnosis and rate their cognitive fatigue using a single item questions as a ≥4 on a numeric rating scale of 0-10 for 1 month or more.
* Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months but no more than 10 years prior to registration.
* May use concurrent adjuvant endocrine therapy and/or HER2-targeted therapy while on study.
* Ability to provide informed written consent.
* Ability to read and write English.
* Ability to be independent in decision making. Must respond No to "Do you have a guardian or blanket power of attorney for legal transactions?"
Exclusion Criteria:
* Other therapies intended to treat CRCI (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per criteria of 4 or more on a 0 to 10 scale).
* Antidepressants (allowed if person has been on them for 30 days prior to registration, and dose or treatment is not expected to change, and CRCI remains sufficiently uncontrolled per inclusion criteria).
* Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days).
* Psychiatric disorder such as severe depression, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
* Pain requiring opioid pain medication.
* Electronic implanted medical device (e.g. pacemaker).
* History of motion sickness within 5 years prior to enrollment will require a tolerability test at baseline.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05030792
Study Brief:
Protocol Section:
NCT05030792