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Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

NCT03046004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-04-06

No results posted yet for this study

Summary

The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.

Conditions

  • Breast Cancer Screening

Interventions

OTHER

Decision aid for breast cancer screening

Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).

OTHER

Standard leaflet

Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.

Sponsors & Collaborators

  • Hospital del Mar

    collaborator OTHER

  • Canary Islands Health Service

    collaborator UNKNOWN

  • Institut Català d'Oncologia

    collaborator OTHER

  • Institut de Recerca Biomèdica de Lleida

    lead OTHER

Principal Investigators

  • Montserrat Rué, PhD · Universitat de Lleida-IRBLLEIDA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
49 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-09-14
Completion
2018-06-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046004 on ClinicalTrials.gov