Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
Public ClinicalTrials.gov record NCT03949270. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
BETA-Text: Evaluating the Efficacy of a Novel, Interactive, Bidirectional Text-messaging Application to Increase Persistence to Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
1. The primary objective is to compare rates of persistence (continuation) of any endocrine therapy (ET) between patients assigned to standard of care follow-up (control arm) versus standard of care plus a bi-directional text messaging intervention (intervention arm) 2. The secondary objectives are: (i) To assess time to permanent discontinuation of ET (switching from an aromatase inhibitor to another ET is permitted). The investigators will also account for treatment breaks. (ii) To assess QOL at baseline, and at 6 and 12 months after initiation of ET (FACT-ES1, Brief Pain Inventory2, Overall Treatment Burden3,4, individual symptom LASA scales4) and compare between arms (iii) To assess adherence self-efficacy (SEAMS5 tool, Voils Extent of Non-Adherence Scale6), financial burden (COST tool7,8), beliefs about medications (modified BMQ tool9,10), and perceived ability to communicate with one's physician (PEPPI11 tool) and compare between arms (iv) To compare the time to endocrine therapy discontinuation in both the intervention and control arms (v) To characterize factors (including clinicopathologic features, socioeconomic status, and comorbidities) associated with non-adherence in both the intervention arm and the control arm, which may enable us to identify women who are at particularly high risk of non-adherence. (vi) To assess adherence to medication as reported through the BETA-Text intervention (vii) To collect the time to onset and trend of severity of side effects in women assigned to the text messaging intervention.
Study identification
- NCT ID
- NCT03949270
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2019
- Primary completion
- Apr 20, 2023
- Completion
- Oct 31, 2023
- Last update posted
- Nov 27, 2023
2019 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06511 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03949270, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03949270 live on ClinicalTrials.gov.