A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early Detection of Cancer
- Sponsor
- Andaluz Health Service
- Enrollment
- 332
- Locations
- 1
- Primary Endpoint
- Change from baseline in knowledge of women participating in the screening program
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
José Manuel Baena Cañada
MD, PhD
Andaluz Health Service
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Attitudes, intention to participate, fear and anxiety of women participating in the screening program(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)