Use of a Radiolucent Pad to Reduce Mammography Among African Americans

Breast Cancer Clinical Trial

Official title:

Use of a Radiolucent Pad to Reduce Mammography Among African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594282
• Other study ID #: 9673
• Secondary ID: POP053504
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: September 10, 2008
• Start date: September 2005

Study information

• Verified date: September 2008
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Radiolucent cushion
MammoPad radiolucent breast plate cushion used during mammogram

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort			No
Secondary	Pre-Mammography Survey, Post-Mammography Survey to assess barriers			No