Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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).

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.

Decision aid for breast cancer screening

Standard leaflet

Montserrat Rué, PhD

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.

The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.

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

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

The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making	NCT03046004	Breast Cancer S...	Decision aid fo... Standard leafle...	49 Years - 50 Years	Institut de Recerca Biomèdica de Lleida

Spots Global Cancer Trial Database for decision aid for breast cancer screening