NCT00594282

Brief Summary

The objective of this study is to assess whether use of a mammography breast plate cushion will significantly decrease the level of discomfort experienced by African American women during routine screening mammograms. The primary hypothesis is that use of the breast plate cushion will result in less mammography-related discomfort. The secondary hypotheses are that women who anticipate high levels of discomfort will experience greater reductions in discomfort when a breast plate cushion is used and participants who received mammograms using a breast plate cushion will have greater intentions to return for a routine mammogram than the control group.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable breast-cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

Enrollment Period

1.8 years

First QC Date

January 2, 2008

Last Update Submit

September 10, 2008

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort

Secondary Outcomes (1)

  • Pre-Mammography Survey, Post-Mammography Survey to assess barriers

Study Arms (2)

1

EXPERIMENTAL

Enhanced Mammography (EM) - Women who are randomized to the Enhanced Mammography (EM) condition will receive a mammogram in which a MammoPad radiolucent breast plate cushion is used.

Device: Radiolucent cushion

2

NO INTERVENTION

Routine Mammography (RM) - Women who are randomized to the Routine Mammography (RM) condition will obtain a routine, un-altered mammogram during which typical exam protocol will be followed and no radiolucent cushion is used.

Interventions

Radiolucent cushionDEVICE

MammoPad radiolucent breast plate cushion used during mammogram

1

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American women
  • years of age or older who presented for a routine screening mammogram

You may not qualify if:

  • Males
  • race other than African American
  • younger than 40 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kim K. Engelman, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Last Updated

September 12, 2008

Record last verified: 2008-09

Locations

US(1)