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Phase 4
30 Years
N/A
Not Enrolling
Female
Breast Pain

Thank you

Trial Information


Breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its
early stages. Mammography is the key component to early detection, yet it remains
underutilized due to cost, access, and factors such as fear of pain.

Multiple studies have shown that most women find mammography uncomfortable, even painful.
Yet, little research has been done to find methods to reduce mammography-related discomfort.
In an unpublished Master’s thesis, this investigator found that women who expected
discomfort > 40 on a visual analog scale (VAS) who were pre-medicated with 1000 mg of
acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but
the sample size was too small to reach statistical significance. Further study on the
effects of pre-medication is needed.

Pain should not be associated with a potentially lifesaving procedure. A more comfortable
and positive experience with mammography may increase the number of women who participate in
regular mammography screening, and, thereby, increase early detection and reduce the
mortality rate, costs, and emotional trauma associated with breast cancer.


Inclusion Criteria:



- Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer
Detection Center

- Expect discomfort of 40 or greater on a scale of 0-100

- Willing to arrive 1 hour early for appointment to enroll in study

Exclusion Criteria:

Women who:

- expect discomfort from their mammogram to be < 40 on a scale of 0-100

- cannot understand or read English or who are unable to complete the consent process
or questionnaire for reasons such as hearing impairment or other physical or mental
disabilities

- have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine

- have significant liver or kidney dysfunction

- are breast-feeding

- cannot arrive a minimum of 60 minutes earlier than their appointment time

- have taken any pain relief medications within 24 hours of their mammogram
appointment, including over-the-counter medications.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram

Principal Investigator

Colleen K. Lambertz, MSN, FNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mountain States Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

MSTMRI - 001

NCT ID:

NCT00382083

Start Date:

March 2006

Completion Date:

June 2006

Related Keywords:

  • Breast Pain
  • Mammogram
  • Pain
  • Discomfort
  • Breast
  • Pre-medication

Name

Location

St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center Boise, Idaho  83712