Clinical Trials Directory

Trials / Completed

CompletedNCT05444725

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3,000 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
Female
Age
44 Years – 49 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERStage of Decision MakingInvestigating 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.
OTHERChoice framingInvestigating 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.
OTHEROpportunity FramingInvestigating 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.

Timeline

Start date
2022-06-22
Primary completion
2022-09-05
Completion
2022-09-05
First posted
2022-07-06
Last updated
2023-05-11

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05444725. Inclusion in this directory is not an endorsement.