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NCT02810236 · ClinicalTrials.gov registry record · NA
Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
A NA study of Anxiety and Breast Diseases, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02810236: Completed NA study of Anxiety and Breast Diseases, sponsored by Duke University.
NCT02810236 is a NA study of Anxiety and Breast Diseases that has completed, run by Duke University. The registered enrollment target is 12 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02810236, a NA study of Anxiety and Breast Diseases, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 - 7/1/2018 will be selected and randomized to three groups using a block randomization technique. All study participants will complete a survey assessing psychosocial factors, then receive a digital mammogram. Patients with a negative mammogram will continue on with the study and will either have a conversation about their negative mammogram with a radiologist or receive a directed ultrasound. A second survey will be conducted assessing psychosocial factors. All study participants who did not receive an ultrasound will receive an ultrasound so that all study participants are provided with the standard of care for focal breast pain. The results of the survey will be compared and appropriate statistical analyses such as an Analysis of Variance (ANOVA) test will be conducted to determine any statistically significant differences between the three randomized groups. The risks/safety issues of this study are believed to be minimal.
Primary Outcome
Measure change in anxiety following intervention using modified STAI
Conditions Studied
Interventions
- BEHAVIORAL Discussion
- PROCEDURE Ultrasound
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2019-11-30 |
| Phase | NA |
What the finished NCT02810236 record still lists
NCT02810236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Discussion is the first listed.
NCT02810236 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02810236 about?
NCT02810236 is a clinical study titled "Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?". The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the ...
What is the current status of trial NCT02810236?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2018-02-01. Estimated completion is 2019-11-30.
What conditions does trial NCT02810236 study?
This clinical trial studies the following conditions: Anxiety, Breast Diseases, Mastodynia.
What interventions are being tested in trial NCT02810236?
The interventions under investigation include: Discussion (BEHAVIORAL), Ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT02810236?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02810236 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02810236's enrollment target sits among peer trials
12 352nd of 364 higher than 11 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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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