NCT02810236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

May 23, 2016

Last Update Submit

December 28, 2022

Conditions

Breast DiseasesMastodyniaAnxiety

Keywords

Focal breast painDirected UltrasoundReassuranceAnxiety

Outcome Measures

Primary Outcomes (1)

  • Change in anxiety using modified STAI questionnaire

    Measure change in anxiety following intervention using modified STAI

    baseline, day 1

Study Arms (2)

No ultrasound

ACTIVE COMPARATOR

No ultrasound recommended. Discussion with radiologist.

Behavioral: Discussion

Ultrasound

ACTIVE COMPARATOR

Ultrasound recommended.

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

Ultrasound will be performed.

Ultrasound
DiscussionBEHAVIORAL

Radiologist will discuss with the patient the findings on mammogram.

No ultrasound

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women
  • over the age of 30
  • primary focal breast pain, i.e. pain localizable by the patient to within one breast quadrant without other associated symptoms.

You may not qualify if:

  • diffuse, radiating, or axillary pain
  • associated palpable findings at the site of pain
  • skin changes (erythema, thickening)
  • nipple changes (discharge, retraction)
  • currently pregnant or breast-feeding
  • history of recent trauma or infection of the affected breast
  • history of ipsilateral breast cancer will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (18)

  • Masroor I, Afzal S, Sakhawat S, Khan N, Beg MA, Kawal D. Negative predictive value of mammography and sonography in mastalgia with negative physical findings. J Pak Med Assoc. 2009 Sep;59(9):598-601.

    PMID: 19750852BACKGROUND

  • Mansel RE. ABC of breast diseases. Breast pain. BMJ. 1994 Oct 1;309(6958):866-8. doi: 10.1136/bmj.309.6958.866. No abstract available.

    PMID: 7950621BACKGROUND

  • Howard MB, Battaglia T, Prout M, Freund K. The effect of imaging on the clinical management of breast pain. J Gen Intern Med. 2012 Jul;27(7):817-24. doi: 10.1007/s11606-011-1982-4. Epub 2012 Jan 31.

    PMID: 22331398BACKGROUND

  • Morrow M. The evaluation of common breast problems. Am Fam Physician. 2000 Apr 15;61(8):2371-8, 2385.

    PMID: 10794579BACKGROUND

  • Jokich P, Newell MS, Bailey L, et al. ACR Appropriateness Criteria® breast pain. Available at http://www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/ BreastPain.pdf. American College of Radiology. Accessed June 20, 2015.

    BACKGROUND

  • Barton MB, Elmore JG, Fletcher SW. Breast symptoms among women enrolled in a health maintenance organization: frequency, evaluation, and outcome. Ann Intern Med. 1999 Apr 20;130(8):651-7. doi: 10.7326/0003-4819-130-8-199904200-00005.

    PMID: 10215561BACKGROUND

  • Preece PE, Mansel RE, Bolton PM, Hughes LM, Baum M, Gravelle IH. Clinical syndromes of mastalgia. Lancet. 1976 Sep 25;2(7987):670-3. doi: 10.1016/s0140-6736(76)92477-6.

    PMID: 60528BACKGROUND

  • Srivastava A, Mansel RE, Arvind N, Prasad K, Dhar A, Chabra A. Evidence-based management of Mastalgia: a meta-analysis of randomised trials. Breast. 2007 Oct;16(5):503-12. doi: 10.1016/j.breast.2007.03.003. Epub 2007 May 16.

    PMID: 17509880BACKGROUND

  • Harvey JA, Mahoney MC, Newell MS, Bailey L, Barke LD, D'Orsi C, Hayes MK, Jokich PM, Lee SJ, Lehman CD, Mainiero MB, Mankoff DA, Patel SB, Reynolds HE, Sutherland ML, Haffty BG. ACR appropriateness criteria palpable breast masses. J Am Coll Radiol. 2013 Oct;10(10):742-9.e1-3. doi: 10.1016/j.jacr.2013.06.013.

    PMID: 24091044BACKGROUND

  • Vaidyanathan L, Barnard K, Elnicki DM. Benign breast disease: when to treat, when to reassure, when to refer. Cleve Clin J Med. 2002 May;69(5):425-32. doi: 10.3949/ccjm.69.5.425.

    PMID: 12022387BACKGROUND

  • Noroozian M, Stein LF, Gaetke-Udager K, Helvie MA. Long-term clinical outcomes in women with breast pain in the absence of additional clinical findings: mammography remains indicated. Breast Cancer Res Treat. 2015 Jan;149(2):417-24. doi: 10.1007/s10549-014-3257-3. Epub 2015 Jan 6.

    PMID: 25556516BACKGROUND

  • Olcucuoglu E, Yilmaz G. Mastodynia: is imaging necessary in young patients? Ulus Cerrahi Derg. 2013 Mar 1;29(1):17-9. doi: 10.5152/UCD.2013.04. eCollection 2013.

    PMID: 25931836BACKGROUND

  • Tumyan L, Hoyt AC, Bassett LW. Negative predictive value of sonography and mammography in patients with focal breast pain. Breast J. 2005 Sep-Oct;11(5):333-7. doi: 10.1111/j.1075-122X.2005.00018.x.

    PMID: 16174154BACKGROUND

  • Leddy R, Irshad A, Zerwas E, Mayes N, Armeson K, Abid M, Cluver A, Campbell A, Ackerman S, Lewis M. Role of breast ultrasound and mammography in evaluating patients presenting with focal breast pain in the absence of a palpable lump. Breast J. 2013 Nov-Dec;19(6):582-9. doi: 10.1111/tbj.12178. Epub 2013 Sep 9.

    PMID: 24011215BACKGROUND

  • Leung JW, Kornguth PJ, Gotway MB. Utility of targeted sonography in the evaluation of focal breast pain. J Ultrasound Med. 2002 May;21(5):521-6; quiz 528-9. doi: 10.7863/jum.2002.21.5.521.

    PMID: 12008815BACKGROUND

  • Duijm LE, Guit GL, Hendriks JH, Zaat JO, Mali WP. Value of breast imaging in women with painful breasts: observational follow up study. BMJ. 1998 Nov 28;317(7171):1492-5. doi: 10.1136/bmj.317.7171.1492.

    PMID: 9831579BACKGROUND

  • Preece PE, Mansel RE, Hughes LE. Mastalgia: psychoneurosis or organic disease? Br Med J. 1978 Jan 7;1(6104):29-30. doi: 10.1136/bmj.1.6104.29.

    PMID: 620138BACKGROUND

  • Spielberger CD. Manual for the State-Trait Anxiety Inventory (Form Y). Palo Alto, CA: Mind Garden; 1983.

    BACKGROUND

MeSH Terms

Conditions

Breast DiseasesMastodyniaAnxiety Disorders

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Michael Taylor-Cho, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Lars Grimm, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 22, 2016

Study Start

February 1, 2018

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

December 30, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)