Monitoring Symptoms to Help Young Women Take Hormone Therapy for Stage I-III Breast Cancer, ASPEN Study

Study Summary

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.

Primary Outcome

Will be assessed by the treating provider at each study visit every 12 weeks and prospectively documented on the S2010 treatment log, including any switch from the initially prescribed oral ET. Persistence with initially prescribed oral ET by intervention arm out to 72 weeks will be described using Kaplan-Meier plots. Potential differences by arm will be tested using multivariable Cox regression. Persistence with any oral ET (aromatase inhibitor \[AI\] and/or tamoxifen) at 72 weeks by arm will b

Conditions Studied

Interventions

• PROCEDURE Biospecimen Collection
• OTHER Questionnaire Administration
• OTHER Best Practice
• BEHAVIORAL Health Education
• PROCEDURE Endocrine Drug Therapy

Study Locations (20)