Investigating Public Enthusiasm for Mammography Screening in Denmark

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT04509063
Collaborator
(none)
768
1
2
1.9
396.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Information about hypothetical mammography screening without benefits
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
768 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
Self administered questionnaire
Primary Purpose:
Health Services Research
Official Title:
Investigating Public Enthusiasm for Mammography Screening in Denmark
Actual Study Start Date :
Nov 6, 2020
Actual Primary Completion Date :
Jan 4, 2021
Actual Study Completion Date :
Jan 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Detailed information about screening harms

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.

Other: Non-detailed information about screening harms

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.

Outcome Measures

Primary Outcome Measures

  1. Irrational preference [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
44 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Residence: Central Denmark Region
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Public Health, Aarhus University Aarhus Denmark 8000

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04509063
Other Study ID Numbers:
  • 2016-051-000001, 1835
First Posted:
Aug 11, 2020
Last Update Posted:
Jan 14, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2021