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

Breast Cancer Screening Clinical Trial

— InforMa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046004
• Other study ID #: PI14/00113
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 20, 2018

Study information

• Verified date: April 2021
• Source: Institut de Recerca Biomèdica de Lleida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 20, 2018
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 49 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Lleida Biomedical Research Institute (IRBLLEIDA)	Lleida

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Recerca Biomèdica de Lleida	Canary Islands Health Service, Catalan Institute of Oncology, Hospital del Mar

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled — View Citation

Pérez-Lacasta MJ, Martínez-Alonso M, Garcia M, Sala M, Perestelo-Pérez L, Vidal C, Codern-Bové N, Feijoo-Cid M, Toledo-Chávarri A, Cardona À, Pons A, Carles-Lavila M, Rue M; with the InforMa Group. Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial. PLoS One. 2019 Mar 26;14(3):e0214057. doi: 10.1371/journal.pone.0214057. eCollection 2019. — View Citation

Pons-Rodríguez A, Martínez-Alonso M, Perestelo-Pérez L, Garcia M, Sala M, Rué M; en nombre del grupo InforMa; El grupo InforMa está formado por. [Informed choice in breast cancer screening: the role of education]. Gac Sanit. 2020 Mar 12. pii: S0213-9111(20)30041-8. doi: 10.1016/j.gaceta.2020.01.002. [Epub ahead of print] Spanish. — View Citation

Toledo-Chávarri A, Rué M, Codern-Bové N, Carles-Lavila M, Perestelo-Pérez L, Pérez-Lacasta MJ, Feijoo-Cid M; InforMa Study Group. A qualitative study on a decision aid for breast cancer screening: Views from women and health professionals. Eur J Cancer Care (Engl). 2017 May;26(3). doi: 10.1111/ecc.12660. Epub 2017 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Informed choice	The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). See Hersch 2015.	Two weeks after the intervention
Secondary	Breast screening attitudes	According to Hersch 2015	Two weeks after the intervention
Secondary	Breast screening intention	According to Hersch 2015	Two weeks after the intervention and after being invited to be screened
Secondary	Decisional conflict	According to Hersch 2015	Two weeks after the intervention
Secondary	Confidence in the decision made	According to Hersch 2015	Two weeks after the intervention
Secondary	Anxiety about screening participation	According to Hersch 2015	Two weeks after the intervention
Secondary	Worry about breast cancer	According to Hersch 2015	Two weeks after the intervention
Secondary	Anticipated regret	According to Hersch 2015	Two weeks after the intervention
Secondary	Time perspective	According to Hersch 2015	Two weeks after the intervention
Secondary	Perceived importance of benefit/harms of screening	According to Hersch 2015	Two weeks after the intervention
Secondary	Perceived risk of breast cancer	According to Hersch 2015	Two weeks after the intervention