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

Not Applicable

Completed

• Conditions: Breast Cancer Screening
• Interventions: Other: Decision aid for breast cancer screening; Other: Standard leaflet

• Registration Number: NCT03046004
• Lead Sponsor: Institut de Recerca Biomèdica de Lleida

Brief 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.

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-04
• Study First Posted: 2017-02-08
• Primary Completion: 2017-09-14
• Study Completion: 2018-06-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands.
• Women with low health literacy will be included

Exclusion Criteria

• Previous history of breast cancer
• Difficulty speaking Spanish or Catalan
• Cognitive impairment to understand or complete the materials based on the interviewer judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid	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).
Control	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.

Primary Outcome Measures

Name	Time	Method
Informed choice	Two weeks after the intervention	The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.

Secondary Outcome Measures

Name	Time	Method
Breast screening attitudes	Two weeks after the intervention	According to Hersch 2015
Breast screening intention	Two weeks after the intervention and after being invited to be screened	According to Hersch 2015
Decisional conflict	Two weeks after the intervention	According to Hersch 2015
Confidence in the decision made	Two weeks after the intervention	According to Hersch 2015
Anxiety about screening participation	Two weeks after the intervention	According to Hersch 2015
Worry about breast cancer	Two weeks after the intervention	According to Hersch 2015
Anticipated regret	Two weeks after the intervention	According to Hersch 2015
Time perspective	Two weeks after the intervention	According to Hersch 2015
Perceived importance of benefit/harms of screening	Two weeks after the intervention	According to Hersch 2015
Perceived risk of breast cancer	Two weeks after the intervention	According to Hersch 2015

Trial Locations

Locations (1)

Lleida Biomedical Research Institute (IRBLLEIDA); 🇪🇸 Lleida, Spain