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NCT03435380 · ClinicalTrials.gov registry record · NA
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 314
- Enrollment target
NCT03435380 is a NA study that has completed, run by Duke University. The registered enrollment target is 314 participants.
The verdict
NCT03435380, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 314 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial using a smartphone intervention with data being collected at baseline and 18-months through patient and provider surveys and medical record review. Eligible women treated for a childhood cancer with chest RT will be randomly sampled from the Childhood Cancer Survivor Study (CCSS) and randomly selected to one of three groups: control, patient activation (PA) using a smartphone-based intervention, or patient activation + primary care provider activation (PA+PCP) which will include physician materials about breast cancer risk in this population along with guidelines for breast cancer surveillance. Participants in all groups will receive mailed targeted print materials as an educational resource about their previous chest radiation and breast cancer screening recommendations. The primary outcome is a medical record confirmed breast MRI and mammogram with the goal of increasing the rate of women completing the national guideline-based recommended combination of breast MRI and mammogram. This study will test the hypothesis that women in the PA and PA+PCP groups will have significantly higher rates of breast cancer surveillance (breast MRI and mammogram) than women in the control group. In addition, the hypothesis that women in the PA+PCP group will have significantly higher rates of breast cancer surveillance than women in the PA group will also be tested.
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Patient activation
- BEHAVIORAL Primary care physician activation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2019-05-07 |
| Est. Completion | 2023-02-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03435380
The ClinicalTrials.gov registry entry for NCT03435380 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 314 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 3 interventions - of which Control is the first listed.
NCT03435380 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03435380 about?
NCT03435380 is a clinical study titled "Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer". The primary purpose of this study is to determine the impact of maximizing patient and primary care provider (PCP) activation on breast cancer surveillance rates among women previously treated with chest radiotherapy (RT) for a childhood cancer. This is an 18-month, 3-arm randomized controlled trial...
What is the current status of trial NCT03435380?
This trial is currently completed. It is a NA study. The enrollment target is 314 participants. The study started on 2019-05-07. Estimated completion is 2023-02-27.
What interventions are being tested in trial NCT03435380?
The interventions under investigation include: Control (BEHAVIORAL), Patient activation (BEHAVIORAL), Primary care physician activation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03435380?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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