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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02480218
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal female, age 65 and older
* No more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (HR+) breast cancer (BC) (i.e., Tumour size 1-2, Node status 0-1, Metastasis 0). HR+ BC defined as \>1% positive cell staining
* Prescribed either tamoxifen, letrozole, or anastrozole
* Fluent in written and spoken English; \>grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid)
* Capacity to provide informed consent
Exclusion Criteria:
* Initiated adjuvant ET more than one week before baseline assessment
* Chemotherapy (neoadjuvant or adjuvant)
* More than one treatment of radiotherapy before baseline assessment
* Hormone replacement therapy use 4 weeks prior to baseline assessment
* Previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure \>5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI); distant metastases
* History of or active known CNS disease (e.g. known diagnosis of stroke, Parkinson's), medical condition impairing cognitive function, including active treatment with medication known to affect cognition, or signs of cognitive impairment on the Memory Impairment Screen
* History or active known diagnosis of major psychiatric disorder in the last 10 years including bipolar disease, schizophrenia, major depression or self-reported hospitalization for psychiatric illness, alcoholism, or history of alcohol or drug abuse
* Life expectancy less than two years, acutely ill or delirious
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
65 Years
Study:
NCT02480218
Study Brief:
Protocol Section:
NCT02480218