NCT03097653

Decision-aid on Breast Cancer Screening

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: Female
• Age: 45 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Decision-aid	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.
OTHER	Standard information	Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-04-20
• Completion: 2019-04-30
• First posted: 2017-03-31
• Last updated: 2021-03-24
• Results posted: 2021-03-24

Locations

7 sites across 1 country: Italy