Clinical trial NCT00594282: Use of a Radiolucent Pad to Reduce Mammography Among African Americans
Official title: Use of a Radiolucent Pad to Reduce Mammography Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2008-01-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort
Secondary outcomes:
measure: Pre-Mammography Survey, Post-Mammography Survey to assess barriers
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kim K. Engelman, PhD
role: PRINCIPAL_INVESTIGATOR
References: