Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context

NCT ID: NCT05444725

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2022-09-05

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.

Detailed Description

In this study, preferences and attitudes towards breast cancer screening, invitation, and decision making among Danish women will be investigated. The aim is to gain knowledge about barriers for (informed) decision making in a Danish breast cancer screening context. The study will be conducted by sending out an online questionnaire to women aged 44-49 in Denmark. The questionnaire will be sent out using the official digital mail system, e-Boks, with an invitation, link, and login information to access the online questionnaire. The questionnaire will consist of background questions about the participants, questions related to the current information material and invitation to the Danish breast cancer screening program, and questions about decision making and informed choice. Women will be randomized to one of three questionnaires: 1) Questionnaire with "Stage of Decision Making" to investigate women's decision making process regarding participation in screening, 2) Questionnaire with choice framing (presentation of a choice between participation in breast cancer screening or no screening), or 3) Questionnaire with opportunity framing (only presentation of screening, no alternative) to investigate decision making process and impact of different framing. 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.

1000 women will be invited to each group in this study and thus 3000 in total, as this is the minimum number satisfying the requirements for both the main hypothesis and secondary aims (not described in detail here). No similar studies were found, therefore, this sample size calculation is based on proportions of 50% to have enough power in our study. With a desired standard error no larger than 2.5%, 400 women are required (SE of a binomial random variable). Assuming 40% participation, a study population of 1000 women in each group is required.

Next, questionnaire data will be linked to register data on sociodemographic factors from Statistics Denmark.

The study is registered at Aarhus University's internal records: 2016-051-000001, 2563.

Conditions

Breast Cancer Female; Mammography Screening; Decision Making; Information Seeking Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Stage of decision making

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.

Group Type: OTHER

Stage of Decision Making

Intervention Type: OTHER

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

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.

Group Type: OTHER

Choice framing

Intervention Type: OTHER

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

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.

Group Type: OTHER

Opportunity Framing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Opportunity 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All women living in Denmark in this age group

Exclusion Criteria

• None

• Minimum Eligible Age: 44 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Public Health, Aarhus University

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 38703097 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-051-000001, 2563

Identifier Type: -

Identifier Source: org_study_id