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NCT04379570 · ClinicalTrials.gov registry record · Phase 3

Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy

A Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.

Active
Registry status
Phase 3
Development phase
1,167
Enrollment target
20
Study locations

NCT04379570 is a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,167 participants, above the 291-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (301% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT04379570, a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,167 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.

Interventions

  • OTHER Questionnaire Administration
  • OTHER Best Practice
  • OTHER Educational Intervention
  • BEHAVIORAL Motivational Interviewing
  • OTHER Text Message-based Navigation Intervention

Study Locations (20)

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • UCSF Cancer Center - Berkeley - Berkeley
  • Alta Bates Summit Medical Center-Herrick Campus - Berkeley
  • Enloe Medical Center - Chico
  • Adventist Health Cancer Care Center Chico - Chico

Arizona

  • Arizona Center for Cancer Care - Gilbert - Gilbert
  • Arizona Center for Cancer Care-Peoria - Peoria
  • Cancer Center at Saint Joseph's - Phoenix
  • Arizona Center for Cancer Care - Phoenix - Phoenix
  • Arizona Center for Cancer Care - Osborn - Scottsdale
  • Arizona Center for Cancer Care - Scottsdale - Scottsdale
  • Arizona Center for Cancer Care-Surprise - Surprise

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Alaska

  • Fairbanks Memorial Hospital - Fairbanks

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith

Trial Details

FieldValue
Enrollment Target 1,167 participants
Start Date 2021-02-15
Est. Completion 2026-08-31
Phase Phase 3

What the Registry Record Tells You About NCT04379570

The ClinicalTrials.gov registry entry for NCT04379570 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,167 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 291-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (301% higher). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Questionnaire Administration is the first listed.

NCT04379570 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT04379570 about?

NCT04379570 is a clinical study titled "Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy". This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take th...

What is the current status of trial NCT04379570?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,167 participants. The study started on 2021-02-15. Estimated completion is 2026-08-31.

What conditions does trial NCT04379570 study?

This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma, HER2-Negative Breast Carcinoma.

What interventions are being tested in trial NCT04379570?

The interventions under investigation include: Questionnaire Administration (OTHER), Best Practice (OTHER), Educational Intervention (OTHER), Motivational Interviewing (BEHAVIORAL), Text Message-based Navigation Intervention (OTHER).

Who is sponsoring clinical trial NCT04379570?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04379570 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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