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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04837820
Eligibility Criteria:
Inclusion Criteria:
* English-proficient adult women with a history of stage 0, I, II, or III breast cancer
* Free of oncologic disease by clinical examination or history
* Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)
* Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 questions
* Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?
* Do you think your mind isn't as sharp now as it was before your cancer diagnosis?
* Do you feel like these problems have made it harder to function on your job or take care of things around the home?
* Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
* Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control
Exclusion Criteria:
* Metastatic breast cancer (stage IV)
* Less than 1 month since completion of surgery, chemotherapy or radiation therapy
* Greater than 10 years since most recent breast cancer diagnosis
* Use of acupuncture for sleep or cognitive symptom management within the past 3 months
* Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
* Score of \>10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135
* Primary psychiatric disorder not in remission
* As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.
* Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments
* Initiation or change in hormonal or targeted therapy within the past 4 weeks
* Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks
* Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks
* Enrolled or plans to enroll on another MSK neurocognitive study
* Unable to provide informed consent for himself/herself
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04837820
Study Brief:
Protocol Section:
NCT04837820