Evidence-informed Choice for Women Participating in Mammography Screening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01335906|
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Early Detection of Cancer||Other: Information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Experimental: Evidence-based informed consent||
The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.
|No Intervention: Usual information|
- Change from baseline in knowledge of women participating in the screening program [ Time Frame: Before randomization (baseline) and one month later ]The primary outcome measure is the level of knowledge obtained in a specific questionnaire, in which there are 7 questions, of which 3 are quantitative with no assumptions and are scored with 2 points. There are also 4 qualitative questions that have 3 assumptions which are scored with 1 point. The maximum score is 10 and minimum 0. It is considered that a woman has made a choice based on adequate knowledge if she gets a score of 6 or more.
- Attitudes, intention to participate, fear and anxiety of women participating in the screening program [ Time Frame: Before randomization (baseline) and one month later. Two years later, women will be called to the follow-up mammography. At this time the real choice taken by woman will be investigated ]The investigators will investigate whether the attitudes of women towards mammography screening are positive or negative. They will respond to 4 questions that are scored from 0 to 6. To know their decision whether to participate in mammography screening they will answer "I am determined to participate" "I am determined not to participate" and "I am undecided". Effective participation will be investigated 2 years later. The level of anxiety and fear of cancer will be measured by "Hospital Anxiety and depression" scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335906
|Oncology Unit, Puerta del Mar University Hospital|
|Cádiz, Andalucía, Spain, 11009|
|Study Chair:||José M Baena-Cañada, MD, PhD||Oncology Unit, University Hospital Puerta del Mar, Cádiz|
|Study Director:||Petra Rosado, MD||Oncology Unit, University Hospital Puerta del Mar, Cádiz|
|Principal Investigator:||Inmaculada Expósito, Chemistry||Oncology Unit, University Hospital Puerta del Mar, Cádiz|
|Principal Investigator:||María del Carmen Díaz, Chemistry||Oncology Unit, University Hospital Puerta del Mar, Cádiz|
|Principal Investigator:||Juan Nieto, MD||Health District Bay of Cádiz-La Janda|