search
Back to results

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

Primary Purpose

Breast Cancer Female, Mammography Screening, Decision Making

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Stage of Decision Making
Choice framing
Opportunity Framing
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Female

Eligibility Criteria

44 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • All women living in Denmark in this age group

Exclusion Criteria:

  • None

Sites / Locations

  • Department of Public Health, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Stage of decision making

Choice framing

Opportunity framing

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
June 3, 2022
Last Updated
May 10, 2023
Sponsor
University of Aarhus
search

1. Study Identification

Unique Protocol Identification Number
NCT05444725
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Mammography Screening, Decision Making, Information Seeking Behavior

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Self administered questionnaire
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage of decision making
Arm Type
Other
Arm Description
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.
Arm Title
Choice framing
Arm Type
Other
Arm Description
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.
Arm Title
Opportunity framing
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stage of Decision Making
Intervention Description
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
Intervention Name(s)
Choice framing
Intervention Description
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
Intervention Name(s)
Opportunity Framing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of women who have made the decision about screening participation prior to screening invitation.
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Prevalence of women not taking the presented screening information into account when making their decision about participation.
Description
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.
Time Frame
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.
Title
Prevalence of women not thinking of the screening participation as an actual (individual) choice but something to comply with when invited.
Description
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.
Time Frame
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.
Title
Prevalence of women not wanting to make an informed decision about their own health (and be responsible for their own health).
Description
This will be investigated with different statements about preferences regarding who should make the screening decision (the individual women or health authorities).
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All women living in Denmark in this age group Exclusion Criteria: None
Facility Information:
Facility Name
Department of Public Health, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not allowed by authorities.

Learn more about this trial

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

We'll reach out to this number within 24 hrs