Investigating Public Enthusiasm for Mammography Screening in Denmark

NCT ID: NCT04509063

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-06

Study Completion Date

2021-01-04

Brief Summary

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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

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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.

Conditions

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Breast Neoplasm Female Mammography Screening Decision Making Information Seeking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Self administered questionnaire

Study Groups

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Detailed information about screening harms

Group Type OTHER

Information about hypothetical mammography screening without benefits

Intervention Type 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.

Non-detailed information about screening harms

Group Type OTHER

Information about hypothetical mammography screening without benefits

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Residence: Central Denmark Region

Exclusion Criteria

\-
Minimum Eligible Age

44 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Public Health, Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 30024212 (View on PubMed)

Rossell EL, Bo A, Gronborg TK, Kristiansen IS, Borgquist S, Scherer LD, Stovring H. Danish Women Want to Participate in a Hypothetical Breast Cancer Screening with Harms and No Reduction in Mortality: A Cross-Sectional Survey. Med Decis Making. 2023 May;43(4):403-416. doi: 10.1177/0272989X231152830. Epub 2023 Feb 3.

Reference Type DERIVED
PMID: 36734154 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-051-000001, 1835

Identifier Type: -

Identifier Source: org_study_id

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