Decision-aid on Breast Cancer Screening
- Conditions
- Breast Cancer
- Interventions
- Other: Decision-aidOther: Standard information
- Registration Number
- NCT03097653
- Lead Sponsor
- Mario Negri Institute for Pharmacological Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1001
- Women aged 45-69, according to the target age of the screening centres involved;
- New invited women in mammography screening programme.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision-aid Decision-aid - Standard information Standard information -
- Primary Outcome Measures
Name Time Method Number of Participants With Adequate Knowledge 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 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 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 Outcome Measures
Name Time Method Participation Rate to the Breast Cancer Screening Programme 15-60 days Participation rate to the breast cancer screening programme will be assessed as a percentage of participants who actually participate, both in intervention and in the control group.
Satisfaction With the Information Measured Using 8 Items With Three Points Scale 7-10 days Satisfaction with the given information will be measured using 8 items with three points scale.
Number of Click on the Homepage Through study completion, an average of 10 days Number of click on the Homepage will be assessed trough Pickwick software.
Number of Times Web Platforms Were Accessed Through study completion, an average of 10 days Number of Times Web Platforms were Accessed assessed trough Pickwick software
Number of Pages Visited on the Web Platforms Through study completion, an average of 10 days Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software.
Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version 7-10 days Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.
Trial Locations
- Locations (7)
Screening Unit, Cancer Prevention and Research Institute - ISPO
🇮🇹Firenze, Italy
UOC Medicina Preventiva delle Comunità - Screening
🇮🇹Milan, Italy
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri
🇮🇹Milan, Italy
U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo
🇮🇹Palermo, Italy
Centro Screeening - AUSL Reggio Emilia
🇮🇹Reggio Emilia, Italy
CPO Piemonte
🇮🇹Torino, Italy
SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza
🇮🇹Torino, Italy