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Completed

NCT Number: NCT04509063

Investigating Public Enthusiasm for Mammography Screening in Denmark

Based on an American study by Scherer et al., it is hypothesized that some women will make irrational choices regarding their participation in mammography screening. Therefore, the aim is to estimate the prevalence of Danish women having an irrational preference for mammography screening even when it confers no benefits, but only harms.

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Key information

Age range

44 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

About this study

The prevalence of women making an irrational decision will be compared to the participation rate in the Danish screening program. The study population will consist of a random sample of women aged 44-49. Similar to the American study, two types of information will be compared (detailed vs. non-detailed information about the harms of screening). Participants will be randomised to one of two information groups. Based on the American study, it is assumed that the willingness to participate in the hypothetical screening program will be 40 percent. To achieve the desired precision in this study, a standard error of 2.5 percent is required corresponding to a confidence interval spanning approximately 35-45 percent. This will require 384 women in each group, corresponding to a total study population of 768. The survey will be sent electronically (using "e-Boks") with a link to access the online survey trial. The survey will consist of screening and cancer related questions as well as questions on age, education, and health literacy. Five questions on appraisal of health information from the Health Literacy Questionnaire will also be included. After the data collection, data will be linked to data on income, residence, civil status, education, breast cancer diagnosis, and information on whether a participant is immigrant, descendent or of Danish origin.

The original plan for the main analysis was to compare the two groups of women randomized to different information groups (detailed vs. non-detailed information about the harms of screening). However, due to lower participation rate and therefore smaller sample size than expected, information group was disregarded in the main analysis. The two groups will still be compared in a secondary analysis. This decision was made before getting access to data from the questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residence: Central Denmark Region

Exclusion criteria

-

Treatment and study plan

Information about hypothetical mammography screening without benefits

Behavioral

We will present an online questionnaire with two types of information on the harms of screening. Then we will compare the prevalence of irrational decisions in the two arms.

Primary outcomes

  1. Irrational preference

    Time frame: The outcome is assessed when women answer the questionnaire which is sent out at the same time to all women. The invited women will have 2 months to answer the questionnaire (it should only take around 15 minutes to answer). Planned from November 2020.

    Willingness to participate in mammography screening with no benefits on morbidity or mortality, only harms. Investigated by sending out questionnaire once to all women.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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