Decision-aid on Breast Cancer Screening

March 1, 2021 updated by: Mario Negri Institute for Pharmacological Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1001

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy
        • Screening Unit, Cancer Prevention and Research Institute - ISPO
      • Milan, Italy, 20122
        • UOC Medicina Preventiva delle Comunità - Screening
      • Milan, Italy, 20156
        • IRCCS-Istituto di Ricerche Farmacologiche Mario Negri
      • Palermo, Italy
        • U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo
      • Reggio Emilia, Italy, 42122
        • Centro Screeening - AUSL Reggio Emilia
      • Torino, Italy
        • CPO Piemonte
      • Torino, Italy
        • SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Decision-aid
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.
ACTIVE_COMPARATOR: Standard information
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation Rate to the Breast Cancer Screening Programme
Time Frame: 15-60 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.
15-60 days
Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Time Frame: 7-10 days
Satisfaction with the given information will be measured using 8 items with three points scale.
7-10 days
Number of Click on the Homepage
Time Frame: Through study completion, an average of 10 days
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
Time Frame: Through study completion, an average of 10 days
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
Time Frame: Through study completion, an average of 10 days
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
Time Frame: 7-10 days
Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

April 20, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

March 16, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (ACTUAL)

March 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRFMN-AIRC-6901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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