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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT03046004
• Date of registration: 04/02/2017
• Prospective Registration: No
• Primary sponsor: Institut de Recerca Biomèdica de Lleida
• Public title: Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making InforMa
• Scientific title: The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making
• Date of first enrolment: July 1, 2016
• Target sample size: 400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03046004
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Montserrat Rué, PhD
• Affiliation: Universitat de Lleida-IRBLLEIDA

Key inclusion & exclusion criteria

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



Age minimum: 49 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer Screening

Intervention(s)

Other: Decision aid for breast cancer screening

Other: Standard leaflet

Primary Outcome(s)

Informed choice [Time Frame: Two weeks after the intervention]

Secondary Outcome(s)

Confidence in the decision made [Time Frame: Two weeks after the intervention]

Perceived risk of breast cancer [Time Frame: Two weeks after the intervention]

Anxiety about screening participation [Time Frame: Two weeks after the intervention]

Breast screening intention [Time Frame: Two weeks after the intervention and after being invited to be screened]

Breast screening attitudes [Time Frame: Two weeks after the intervention]

Perceived importance of benefit/harms of screening [Time Frame: Two weeks after the intervention]

Time perspective [Time Frame: Two weeks after the intervention]

Anticipated regret [Time Frame: Two weeks after the intervention]

Decisional conflict [Time Frame: Two weeks after the intervention]

Worry about breast cancer [Time Frame: Two weeks after the intervention]

Secondary ID(s)

PI14/00113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital del Mar

Catalan Institute of Oncology

Canary Islands Health Service