We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Decision-aid on Breast Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03097653
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Decision-aid Other: Standard information Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1001 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : April 20, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. 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".

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097653

Layout table for location information
Screening Unit, Cancer Prevention and Research Institute - ISPO
Firenze, Italy
UOC Medicina Preventiva delle Comunità - Screening
Milan, Italy, 20122
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri
Milan, Italy, 20156
U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo
Palermo, Italy
Centro Screeening - AUSL Reggio Emilia
Reggio Emilia, Italy, 42122
CPO Piemonte
Torino, Italy
SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza
Torino, Italy
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
  Study Documents (Full-Text)

Documents provided by Mario Negri Institute for Pharmacological Research:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03097653    
Other Study ID Numbers: IRFMN-AIRC-6901
First Posted: March 31, 2017    Key Record Dates
Results First Posted: March 24, 2021
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Negri Institute for Pharmacological Research:
breast cancer screening
informed choice
National Cancer Screening Program
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases