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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: Active 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,167 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 3 |
What the registry record for NCT04379570 still lists
NCT04379570 is an interventional study that assigns participants to a tested intervention. Its 1,167 participants enrollment target places it among the larger protocols in the corpus, above the 291-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (301% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT04379570's enrollment target sits among peer trials
1,167 8th of 84 higher than 77 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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