Use of a Radiolucent Pad to Reduce Mammography Among African Americans
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort
No
Kim K. Engelman, PhD
Principal Investigator
University of Kansas
United States: Institutional Review Board
9673
NCT00594282
September 2005
Name | Location |
---|---|
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |