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Decision-aid on Breast Cancer Screening

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Other: Decision-aid
Other: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Decision-aidDecision-aid-
Standard informationStandard information-
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adequate Knowledge7-10 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".

Attitude7-10 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.

Intention7-10 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
NameTimeMethod
Participation Rate to the Breast Cancer Screening Programme15-60 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 Scale7-10 days

Satisfaction with the given information will be measured using 8 items with three points scale.

Number of Click on the HomepageThrough 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 AccessedThrough 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 PlatformsThrough 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 Version7-10 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

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