Use of a Radiolucent Pad to Reduce Mammography Among African Americans

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00594282
First received: January 2, 2008
Last updated: September 10, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Breast Cancer
Device: Radiolucent cushion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Use of a Radiolucent Pad to Reduce Mammography Among African Americans

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-Mammography Survey, Post-Mammography Survey to assess barriers [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: September 2005
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
MammoPad radiolucent breast plate cushion used during mammogram
No Intervention: 2
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.

Detailed Description:

Despite improvements over the past decade, routine mammography screening rates among African American women remain suboptimal. This is especially troubling in light of the fact that African American women have higher breast cancer mortality rates than White and Hispanic women. Multiple studies have revealed that women experience varying levels of pain during mammography, however, African American women report higher levels of mammography-related pain than their White counterparts. In fact, the fear of pain associated with mammography is so prominent that it prevents some women from undergoing routine screenings or follow-ups. Since pain is a major barrier for many African American women in the screening process, studies to assess methods to reduce mammography-related pain are imperative. An FDA-approved radiolucent breast plate cushion has been developed for use during mammography to increase comfort during the exam. The purpose of this study is to evaluate whether use of this radiolucent cushion will decrease the level of pain experienced by African American women undergoing routine screening mammography, positively impact routine mammography screening intentions, and result in greater mammography satisfaction among African American women. 304 women scheduled for mammograms at three community metropolitan mammography facilities participated in this study. One-half of the women were randomized to an Enhanced Mammography (EM) condition in which a radiolucent cushion was used during mammograms. The other half were randomized to a Routine Mammography (RM) condition during which typical exam protocol is followed and no radiolucent cushion was used. Pre- and post-exam surveys assessed anticipated and experienced exam-related pain and discomfort, intentions to return for a future routine mammogram, and general visit satisfaction. A follow-up telephone interview will be conducted with study participants to determine whether they received a follow-up routine screening mammogram 12 to 18 months after they were enrolled in the study (at the time of their last routine screening mammogram) and where they received their mammogram (e.g. did they return to the same facility). If they did not obtain an on-time routine screening mammogram barriers were assessed. The RM and EM groups will be compared for differences.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Males
  • race other than African American
  • younger than 40 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594282

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Kim K. Engelman, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Kim K. Engelman, PhD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00594282     History of Changes
Other Study ID Numbers: 9673, POP053504
Study First Received: January 2, 2008
Last Updated: September 10, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014