NCT05444725

Brief Summary

The aim is to investigate potential barriers to informed decision making in a breast cancer screening context. This is a necessary step prior to developing and investigating improved information or decision aids in a Danish breast cancer screening context.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

June 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

May 11, 2023

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 3, 2022

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of women who have made the decision about screening participation prior to screening invitation.

    The main hypothesis for this study is that 80% of Danish women have already made their decision about screening participation when presented to the opportunity framing and 70% when presented to the choice framing. Further, a question about being more or less willing to participate after reading screening information will also provide information for this hypothesis.

    The outcome is assessed when women answer the questionnaire sent out in late June 2022. It will take 5-10 minutes to answer the questionnaire. The questionnaire will be closed after 1.5-2 months.

Secondary Outcomes (3)

  • Prevalence of women not taking the presented screening information into account when making their decision about participation.

    The outcome is assessed when women answer the questionnaire sent out in late June 2022. It will take 5-10 minutes to answer the questionnaire. The questionnaire will be closed after 1.5-2 months.

  • Prevalence of women not thinking of the screening participation as an actual (individual) choice but something to comply with when invited.

    The outcome is assessed when women answer the questionnaire sent out in late June 2022. It will take 5-10 minutes to answer the questionnaire. The questionnaire will be closed after 1.5-2 months.

  • Prevalence of women not wanting to make an informed decision about their own health (and be responsible for their own health).

    The outcome is assessed when women answer the questionnaire sent out in late June 2022. It will take 5-10 minutes to answer the questionnaire. The questionnaire will be closed after 1.5-2 months.

Study Arms (3)

Stage of decision making

OTHER

Same questionnaire for all three arms except validated question "Stage of decision making" followed by question about participation in screening or not when invited at age 50. This is not an intervention but a survey study with three different versions of the questionnaire.

Other: Stage of Decision Making

Choice framing

OTHER

Same questionnaire for all three arms except text and question presenting breast cancer screening as a choice (between screening and alternative of no screening) followed by question about participation in screening or not when invited at age 50. This is not an intervention but a survey study with three different versions of the questionnaire.

Other: Choice framing

Opportunity framing

OTHER

Same questionnaire for all three arms except text and question presenting breast cancer screening as an opportunity (no presentation of alternative) followed by question about participation in screening or not when invited at age 50. This is not an intervention but a survey study with three different versions of the questionnaire.

Other: Opportunity Framing

Interventions

Investigating preferences and attitudes towards breast cancer screening information, invitation, and decision making as well as barriers for breast cancer decision making. This will be done by using different framing of information (choice framing vs. opportunity framing), question about stage of decision making, and general questions about screening information and invitation.

Stage of decision making

Investigating preferences and attitudes towards breast cancer screening information, invitation, and decision making as well as barriers for breast cancer decision making. This will be done by using different framing of information (choice framing vs. opportunity framing), question about stage of decision making, and general questions about screening information and invitation.

Choice framing

Investigating preferences and attitudes towards breast cancer screening information, invitation, and decision making as well as barriers for breast cancer decision making. This will be done by using different framing of information (choice framing vs. opportunity framing), question about stage of decision making, and general questions about screening information and invitation.

Opportunity framing

Eligibility Criteria

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

You may qualify if:

  • All women living in Denmark in this age group

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Rossell EL, Bekker HL, Schonberg MA, Sonbo Kristiansen I, Borgquist S, Stovring H. Danish Women Make Decisions about Participation in Breast Cancer Screening prior to Invitation Information: An Online Survey Using Experimental Methods. Med Decis Making. 2024 Aug;44(6):674-688. doi: 10.1177/0272989X241248142. Epub 2024 May 4.

MeSH Terms

Conditions

Information Seeking Behavior

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Self administered questionnaire
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2022

First Posted

July 6, 2022

Study Start

June 22, 2022

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

May 11, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Not allowed by authorities.

Locations