Clinical trial NCT05444725: Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context
Official title: Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Mammography Screening
Decision Making
Information Seeking Behavior
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 44
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self administered questionnaire
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* All women living in Denmark in this age group

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of women who have made the decision about screening participation prior to screening invitation.
timeFrame: 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:
measure: Prevalence of women not taking the presented screening information into account when making their decision about participation.
timeFrame: 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.
measure: Prevalence of women not thinking of the screening participation as an actual (individual) choice but something to comply with when invited.
timeFrame: 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.
measure: Prevalence of women not wanting to make an informed decision about their own health (and be responsible for their own health).
timeFrame: 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.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Public Health, Aarhus University
Study officials:
References: