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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
ct.gov registration not required
Open to Enrollment
Yes

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

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@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

Principal Investigator
Marcela Mazo Canola