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

January 2, 2008
September 10, 2008
September 2005
July 2007   (final data collection date for primary outcome measure)
A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort [ Designated as safety issue: No ]
A Pre-Mammography Survey and Post-Mammography Survey [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00594282 on ClinicalTrials.gov Archive Site
Pre-Mammography Survey, Post-Mammography Survey to assess barriers [ Designated as safety issue: No ]
Pre-Mammography Survey, Post-Mammography Survey [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Use of a Radiolucent Pad to Reduce Mammography Among African Americans
Use of a Radiolucent Pad to Reduce Mammography Among African Americans

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Breast Cancer
Device: Radiolucent cushion
MammoPad radiolucent breast plate cushion used during mammogram
  • 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.
    Intervention: Device: Radiolucent cushion
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
Not Provided
July 2007   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00594282
9673, POP053504
Yes
Kim K. Engelman, PhD, University of Kansas Medical Center
University of Kansas
Susan G. Komen Breast Cancer Foundation
Principal Investigator: Kim K. Engelman, PhD University of Kansas
University of Kansas
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP