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

NCT05568472 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Hormone Receptor-Positive Breast Carcinoma

Interventions

OTHER

Best Practice

Standard of care hormone therapy and standard visit with clinician

PROCEDURE

Biospecimen Collection

Undergo correlative studies

PROCEDURE

Endocrine Drug Therapy

Undergo endocrine therapy

BEHAVIORAL

Health Education

Receive list of websites

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Symptom Specific Assessment Tool

Receive a weblink via email or text message and asked 6 brief questions about symptoms

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Norah L Henry · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2027-05-01
Completion
2028-05-01

Countries

  • United States
  • Peru

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05568472 on ClinicalTrials.gov