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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05444725
• Other study ID #: 2016-051-000001, 2563
• Status: Completed
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: June 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 44 Years to 49 Years

Eligibility

Inclusion Criteria:

• All women living in Denmark in this age group

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Decision Making
• Information Seeking Behavior
• Mammography Screening

Intervention

Other:
• 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
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.

Locations

Country	Name	City	State
Denmark	Department of Public Health, Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of women not taking the presented screening information into account when making their decision about participation.	This will be investigated by comparing the choice vs. opportunity framing, with questions about reading health information in general and about having read the information about breast cancer screening in this questionnaire. In addition, this will be investigated with questions about being more or less positive/negative about screening and more or less willing to participate after reading the screening information.	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	Prevalence of women not thinking of the screening participation as an actual (individual) choice but something to comply with when invited.	This will be investigated using two statements about seeing the participation as an individual choice or as a recommendation from health authorities to comply with.	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	Prevalence of women not wanting to make an informed decision about their own health (and be responsible for their own health).	This will be investigated with different statements about preferences regarding who should make the screening decision (the individual women or health authorities).	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.