Investigating Public Enthusiasm for Mammography Screening in Denmark
Primary Purpose
Breast Neoplasm Female, Mammography Screening, Decision Making
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Information about hypothetical mammography screening without benefits
Sponsored by
About this trial
This is an interventional health services research trial for Breast Neoplasm Female focused on measuring Breast cancer, Mammography screening, Decision Making, Information Seeking Behavior
Eligibility Criteria
Inclusion Criteria:
- Residence: Central Denmark Region
Exclusion Criteria:
-
Sites / Locations
- Department of Public Health, Aarhus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Detailed information about screening harms
Non-detailed information about screening harms
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509063
Brief Title
Investigating Public Enthusiasm for Mammography Screening in Denmark
Official Title
Investigating Public Enthusiasm for Mammography Screening in Denmark
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
January 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Mammography Screening, Decision Making, Information Seeking Behavior
Keywords
Breast cancer, Mammography screening, Decision Making, Information Seeking Behavior
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Self administered questionnaire
Allocation
Randomized
Enrollment
768 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Detailed information about screening harms
Arm Type
Other
Arm Title
Non-detailed information about screening harms
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Information about hypothetical mammography screening without benefits
Intervention Description
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 Outcome Measure Information:
Title
Irrational preference
Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Residence: Central Denmark Region
Exclusion Criteria:
-
Facility Information:
Facility Name
Department of Public Health, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not allowed by authorities.
Citations:
PubMed Identifier
30024212
Citation
Scherer LD, Valentine KD, Patel N, Baker SG, Fagerlin A. A bias for action in cancer screening? J Exp Psychol Appl. 2019 Jun;25(2):149-161. doi: 10.1037/xap0000177. Epub 2018 Jul 19.
Results Reference
background
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Investigating Public Enthusiasm for Mammography Screening in Denmark
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