NCT04509063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
768

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

June 29, 2020

Last Update Submit

January 11, 2021

Conditions

Keywords

Breast cancerMammography screeningDecision MakingInformation Seeking Behavior

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

Detailed information about screening harms

OTHER
Behavioral: Information about hypothetical mammography screening without benefits

Non-detailed information about screening harms

OTHER
Behavioral: Information about hypothetical mammography screening without benefits

Interventions

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.

Detailed information about screening harmsNon-detailed information about screening harms

Eligibility Criteria

Age44 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Residence: Central Denmark Region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 30024212BACKGROUND
  • 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.

MeSH Terms

Conditions

Information Seeking BehaviorBreast Neoplasms

Condition Hierarchy (Ancestors)

CommunicationBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Self administered questionnaire
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

August 11, 2020

Study Start

November 6, 2020

Primary Completion

January 4, 2021

Study Completion

January 4, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Not allowed by authorities.

Locations