NCT03046004

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Institut de Recerca Biomèdica de Lleida · Academic / Other
• Sex: Female
• Age: 49 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer Screening

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-09-14
• Completion: 2018-06-20
• First posted: 2017-02-08
• Last updated: 2021-04-06

Locations

1 site across 1 country: Spain