S2010, A RANDOMIZED PHASE III TRIAL COMPARING ACTIVE SYMPTOM MONITORING PLUS PATIENT EDUCATION VERSUS PATIENT EDUCATION ALONE TO IMPROVE PERSISTENCE WITH ENDOCRINE THERAPY IN YOUNG WOMEN WITH STAGE I-III BREAST CANCER (ASPEN)
Lay Description
This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines
Category
- Cancers and Other Neoplasms
- Womens Health
- Breast
- IRB Number
- 20230088HU
- NCT Number
- NCT # not yet entered
Eligibility
- Eligible Ages
- Above 18
- Eligible Genders
- Female
- Accepts Healthy Volunteers
Inclusion Criteria
a. Participants must be female and have Stage I, II, or III hormone receptor positive breast cancer based on clinical or pathologic evaluation (See Section 4.0).
b. Participants must have been pre- or peri-menopausal at the time of breast cancer diagnosis by satisfying one of the following:
1. had a menstrual period (by self-report) within the 12 months before breast cancer diagnosis, or
2. had a serum or plasma estradiol and/or FSH concentration consistent with premenopausal status (based on institutional standards) within the 12 months before breast cancer diagnosis or when checked after breast cancer diagnosis.
c. Participants must not have distant metastatic breast cancer.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Jessica Villarreal
villarreal24@uthscsa.edu
Principal Investigator
Marcela Mazo Canola