Know Cancer

or
forgot password

Use of a Radiolucent Pad to Reduce Mammography Among African Americans


N/A
40 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Kim K. Engelman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9673

NCT ID:

NCT00594282

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of Kansas Medical Center Kansas City, Kansas  66160-7353