Decision-aid on Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097653
• Other study ID #: IRFMN-AIRC-6901
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2021
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: April 30, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Screening Unit, Cancer Prevention and Research Institute - ISPO	Firenze
Italy	IRCCS-Istituto di Ricerche Farmacologiche Mario Negri	Milan
Italy	UOC Medicina Preventiva delle Comunità - Screening	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

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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, Marchiò V, Deandrea S, Silvestri A, Luciano D, Paci E, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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