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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Radiolucent cushion

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Pre-Mammography Survey, Post-Mammography Survey to assess barriers

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: Susan G. Komen Breast Cancer Foundation
• Investigators: Principal Investigator: Kim K. Engelman, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 14, 2008
• First Posted (Estimate): January 15, 2008

Study Record Updates

• Last Update Posted (Estimate): September 12, 2008
• Last Update Submitted That Met QC Criteria: September 10, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: 9673 (Other Identifier: CTEP); POP053504