An interventional study of Information about hypothetical mammography screening without benefits in Breast Neoplasm Female, Mammography Screening and Decision Making, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to female participants aged 44 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by University of Aarhus · Not applicable, Interventional, and Health services research
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 768 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
Behavioral: Information about hypothetical mammography screening without benefits
Behavioral: Information about hypothetical mammography screening without benefits
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.
Irrational preference
Willingness to participate in mammography screening with no benefits on morbidity or mortality, only harms. Investigated by sending out questionnaire once to all women.
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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Not allowed by authorities.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus