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NCT02707471 · ClinicalTrials.gov registry record · NA
Improving Well-Being for Breast Cancer Patients
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 312
- Enrollment target
NCT02707471 is a NA study that has completed, run by Duke University. The registered enrollment target is 312 participants.
The verdict
NCT02707471, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 312 participants
- Enrollment target
Study Summary
Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in our preliminary work, 65% of breast cancer patients taking AET reported one or more non-adherent medication taking behaviors (e.g., skipped dose, forgot, adjusted dose) in the past month. Symptoms (e.g., arthralgia, vasomotor symptoms) associated with AET are strongly related to non-adherence and early discontinuation of treatment. Poor adherence to AET due to symptoms may compromise the effectiveness of AET. Prior to conducting a clinical trial, we will conduct user testing of the self-management intervention protocol with 20 women. In the proposed randomized clinical trial, 400 women who are taking AET for breast cancer will be randomly assigned to one of two conditions: 1) a self-management intervention for improving adherence and symptom management, or 2) a general health education control condition. The self-management intervention integrates three key theory-based strategies for improving adherence to AET: coping skills training for managing symptoms (e.g., arthralgia, vasomotor symptoms), behavioral strategies for improving medication adherence, and symptom and medication education. The intervention addresses the specific symptoms a woman is experiencing and is designed to meet the needs of women who are at high risk for non-adherence to AET (e.g., low socioeconomic status, low literacy). The self-management intervention is administered by a nurse via the telephone, and combines the use of phone calls and tailored interactive voice messaging based on information exchanged during phone sessions and real-time adherence data obtained from smart medication bottles. Women randomly assigned to the control condition will receive a general health education intervention that is delivered by a nurse via
Interventions
- BEHAVIORAL SM-AET
- BEHAVIORAL general health education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2023-11-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02707471
The ClinicalTrials.gov registry entry for NCT02707471 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SM-AET is the first listed.
NCT02707471 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02707471 about?
NCT02707471 is a clinical study titled "Improving Well-Being for Breast Cancer Patients". Adjuvant endocrine therapy (AET) is a crucial component of treatment used to prevent recurrence and reduce breast cancer-related mortality for breast cancer patients with hormone receptor positive disease. Studies report low rates of adherence to AET (38% to 86%) and in our preliminary work, 65% of ...
What is the current status of trial NCT02707471?
This trial is currently completed. It is a NA study. The enrollment target is 312 participants. The study started on 2017-03-14. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT02707471?
The interventions under investigation include: SM-AET (BEHAVIORAL), general health education (BEHAVIORAL).
Who is sponsoring clinical trial NCT02707471?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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