New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Mario Negri Institute for Pharmacological Research
- Enrollment
- 1001
- Locations
- 7
- Primary Endpoint
- Number of Participants With Adequate Knowledge
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.
Detailed Description
Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women aged 45-69, according to the target age of the screening centres involved;
- •New invited women in mammography screening programme.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Adequate Knowledge
Time Frame: 7-10 days
Knowledge will be measured using a questionnaire structured in 13 questions with multiple choice answers, with 2 to 4 options. Ten questions will be qualitative and 3 will be numerical. A score of 8 out of 13 (about 60%) or higher would be considered "adequate knowledge".
Attitude
Time Frame: 7-10 days
Attitude will be measured through a scale of 6 items with 5 response options from 1 to 5, with a total score from 6 to 30. The investigators set the threshold for a positive attitude at 24 and consequently the score \<24 point a negative attitude.
Intention
Time Frame: 7-10 days
Intention will be measured using 1 item with 5 responses: Definitely will, Likely to, Unsure, Not likely to, Definitely will not. The investigators classified "definitely will" and "likely to" as positive intentions.
Secondary Outcomes
- Participation Rate to the Breast Cancer Screening Programme(15-60 days)
- Satisfaction With the Information Measured Using 8 Items With Three Points Scale(7-10 days)
- Number of Click on the Homepage(Through study completion, an average of 10 days)
- Number of Times Web Platforms Were Accessed(Through study completion, an average of 10 days)
- Number of Pages Visited on the Web Platforms(Through study completion, an average of 10 days)
- Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version(7-10 days)