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

Institut de Recerca Biomèdica de Lleida

Status: Completed

Conditions: Breast Cancer Screening

Treatments: Other: Standard leaflet; Other: Decision aid for breast cancer screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03046004

PI14/00113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: Female

Ages: 49 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Decision aid

Experimental group

Description:

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).

Treatment:

Other: Decision aid for breast cancer screening

Control

Active Comparator group

Description:

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.

Treatment:

Other: Standard leaflet