Evidence-informed Choice for Women Participating in Mammography Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
José Manuel Baena Cañada, Andaluz Health Service
ClinicalTrials.gov Identifier:
NCT01335906
First received: April 6, 2011
Last updated: June 23, 2014
Last verified: June 2014

April 6, 2011
June 23, 2014
January 2011
December 2013   (final data collection date for primary outcome measure)
Change from baseline in knowledge of women participating in the screening program [ Time Frame: Before randomization (baseline) and one month later ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01335906 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Evidence-informed Choice for Women Participating in Mammography Screening
A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening

Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and risks of mammography screening increases the women´s knowledge of it; allows women to make an informed decision on whether to stop or continue the screening program, changing the actual participation rate; anxiety and fear are not increased. Design: randomized controlled clinical trial with non-pharmacological intervention. Subjects and setting of study: women referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions: random assignment of women in two arms according to the information provided. Control arm is the standard information; it consists of receiving information normally provided to women attending the screening program for breast cancer. Intervention arm is the experimental information and consists of receiving accurate verbal and written information about the benefits and real risks of mammography screening programs by a physician investigator. Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Early Detection of Cancer
Other: Information
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.
  • Experimental: Evidence-based informed consent
    Intervention: Other: Information
  • No Intervention: Usual information
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women living in the Bay Health District Cádiz-La Janda
  • Women aged between 45 and 69 years
  • Women invited to breast screening program and who attend it
  • Qualified women to give informed consent to participate in the study

Exclusion Criteria:

  • Women with a history of breast cancer
Female
45 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01335906
PI-0315-2010
No
José Manuel Baena Cañada, Andaluz Health Service
Andaluz Health Service
Not Provided
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
Andaluz Health Service
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP