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|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 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.
|United States, Texas|
|Cancer Therapy and Research Center at UTHSCSA|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Kenneth Kist, MD||University of Texas|