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NCT03949270 · ClinicalTrials.gov registry record · NA
Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT03949270 is a NA study that has completed, run by Yale University. The registered enrollment target is 400 participants.
The verdict
NCT03949270, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL BETA-Text text messaging intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2023-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03949270
The ClinicalTrials.gov registry entry for NCT03949270 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BETA-Text text messaging intervention is the first listed.
NCT03949270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03949270 about?
NCT03949270 is a clinical study titled "Text Messaging in Patients on Adjuvant Endocrine Therapy for Breast Cancer". 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:...
What is the current status of trial NCT03949270?
This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2019-07-22. Estimated completion is 2023-11-01.
What interventions are being tested in trial NCT03949270?
The interventions under investigation include: BETA-Text text messaging intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03949270?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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