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

May 10, 2023 updated by: University of Aarhus
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Henrik Støvring, DrMedSci, PhD, MSc
  • Phone Number: +45 8716 7991
  • Email: stovring@ph.au.dk

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Public Health, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

44 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All women living in Denmark in this age group

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
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.
Other: 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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of women who have made the decision about screening participation prior to screening invitation.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of women not taking the presented screening information into account when making their decision about participation.
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.
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.
Prevalence of women not thinking of the screening participation as an actual (individual) choice but something to comply with when invited.
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.
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.
Prevalence of women not wanting to make an informed decision about their own health (and be responsible for their own health).
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-051-000001, 2563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not allowed by authorities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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