Women's Mammography Study To Improve Comfort During Mammography
The purpose of this study is to determine in a randomized trial whether it is possible to decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a scripted, supportive text informing patients about mammography.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45|
- Measure of discomfort of mammography [ Time Frame: 3 years ] [ Designated as safety issue: No ]The Primary outcome measure will be the response to question 1 of the post-mammogram questionnaire: 'How painful was today's mammogram?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst]. The response to question 2, 'Was the amount of pain you experienced something that might make you reluctant to return for your next mammogram?' [yes, no] will be of secondary interest. The response to question 5 of the pre-mammogram questionnaire: 'How painful do you expect today's mammogram to be?' [O-no hurt, 1-hurts a little bit, 2-hurts a little more, 3-hurts even more, 4-hurts a whole lot, 5-hurts worst] will be used for statistical adjustment and to compute a change score as described in the protocol.
|Study Start Date:||July 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Ibuprofen
Pfizer 200 mg caplets (Advil)
Placebo Comparator: Placebo
This study is designed to evaluate two methods of reducing pain and discomfort caused by mammography, one of the barriers to the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716052
|United States, Texas|
|Cancer Therapy and Research Center at UTHSCSA|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Kenneth Kist, MD||University of Texas|