Clinical trial NCT03097653: Decision-aid on Breast Cancer Screening
Official title: New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer screening
mammography
decision-aid
informed choice
National Cancer Screening Program
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 1001
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

* None

Primary outcomes:
measure: Number of Participants With Adequate Knowledge
timeFrame: 7-10 days
measure: Attitude
timeFrame: 7-10 days
measure: Intention
timeFrame: 7-10 days
Secondary outcomes:
measure: Participation Rate to the Breast Cancer Screening Programme
timeFrame: 15-60 days
measure: Satisfaction With the Information Measured Using 8 Items With Three Points Scale
timeFrame: 7-10 days
measure: Number of Click on the Homepage
timeFrame: Through study completion, an average of 10 days
measure: Number of Times Web Platforms Were Accessed
timeFrame: Through study completion, an average of 10 days
measure: Number of Pages Visited on the Web Platforms
timeFrame: Through study completion, an average of 10 days
measure: Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Screening Unit, Cancer Prevention and Research Institute - ISPO
city: Milan
country: Italy
facility: UOC Medicina Preventiva delle Comunità - Screening
city: Milan
country: Italy
facility: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri
city: Palermo
country: Italy
facility: U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo
city: Reggio Emilia
country: Italy
facility: Centro Screeening - AUSL Reggio Emilia
city: Torino
country: Italy
facility: CPO Piemonte
city: Torino
country: Italy
facility: SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza
Study officials:
References:
citation: Roberto A, Colombo C, Candiani G, Giordano L, Mantellini P, Paci E, Satolli R, Valenza M, Mosconi P. Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial. BMC Cancer. 2017 Jun 19;17(1):429. doi: 10.1186/s12885-017-3428-9.
citation: Roberto A, Colombo C, Candiani G, Satolli R, Giordano L, Jaramillo L, Castagno R, Mantellini P, Falini P, Carnesciali E, Valenza M, Costa L, Campari C, Caroli S, Faggiano RC, Orione L, Belmessieri B, Marchio V, Deandrea S, Silvestri A, Luciano D, Paci E, Mosconi P. A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy. Br J Cancer. 2020 Sep;123(5):714-721. doi: 10.1038/s41416-020-0935-2. Epub 2020 Jun 17.