Decision-aid on Breast Cancer Screening

NCT ID: NCT03097653

Last Updated: 2021-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Decision-aid

Group Type EXPERIMENTAL

Decision-aid

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Standard information

Intervention Type OTHER

Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Screening Unit, Cancer Prevention and Research Institute - ISPO

Florence, , Italy

Site Status

UOC Medicina Preventiva delle Comunità - Screening

Milan, , Italy

Site Status

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri

Milan, , Italy

Site Status

U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo

Palermo, , Italy

Site Status

Centro Screeening - AUSL Reggio Emilia

Reggio Emilia, , Italy

Site Status

CPO Piemonte

Torino, , Italy

Site Status

SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza

Torino, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 28629329 (View on PubMed)

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.

Reference Type RESULT
PMID: 32546834 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRFMN-AIRC-6901

Identifier Type: -

Identifier Source: org_study_id

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