Decision-aid on Breast Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Decision-aid
* Other: Standard information


Participation Criteria
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Eligibility Criteria
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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: None

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision-aid<br> | Other: Decision-aid<br>* Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.<br>|
| Active Comparator: Standard information<br> | Other: Standard information<br>* Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adequate Knowledge | 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. | 7-10 days | 
| Attitude | 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. | 7-10 days | 
| Intention | 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. | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation Rate to the Breast Cancer Screening Programme | 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. | 15-60 days | 
| Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Satisfaction with the given information will be measured using 8 items with three points scale. | 7-10 days | 
| Number of Click on the Homepage | Number of click on the Homepage will be assessed trough Pickwick software. | Through study completion, an average of 10 days | 
| Number of Times Web Platforms Were Accessed | Number of Times Web Platforms were Accessed assessed trough Pickwick software | Through study completion, an average of 10 days | 
| Number of Pages Visited on the Web Platforms | Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software. | Through study completion, an average of 10 days | 
| Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale. | 7-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer screening, mammography, decision-aid, informed choice, National Cancer Screening Program