Breast Cancer FemaleNCT05444725
Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context
A study testing Stage of Decision Making, Choice framing and Opportunity Framing in people with Breast Cancer Female and Mammography Screening, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 44 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Mammography Screening, Decision Making
- What is being tested?
- Stage of Decision Making, Choice framing and Opportunity Framing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jun 2022to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women living in Denmark in this age group
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Breast Cancer Female, Mammography Screening, Decision Making, Information Seeking Behavior
- Being tested
- Stage of Decision Making, Choice framing, Opportunity Framing
- Medical subject headings
- Information Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage of Decision MakingOther
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 framingOther
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 FramingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage of decision making | Other | 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. Receives: Other: Stage of Decision Making |
| Choice framing | Other | 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. Receives: Other: Choice framing |
| Opportunity framing | Other | 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. Receives: Other: Opportunity Framing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: 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.
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.
Measured: 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).
This will be investigated with different statements about preferences regarding who should make the screening decision (the individual women or health authorities).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start22 Jun 2022
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Self administered questionnaire
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444725
- Sponsor's protocol ID
- 2016-051-000001, 2563
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by authorities.
Publications
Rossell EL, Bekker HL, Schonberg MA, Sonbo Kristiansen I, Borgquist S, Stovring H. Danish Women Make Decisions about Participation in Breast Cancer Screening prior to Invitation Information: An Online Survey Using Experimental Methods. Med Decis Making. 2024 Aug;44(6):674-688. doi: 10.1177/0272989X241248142. Epub 2024 May 4.
PubMed 38703097
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Barriers for Decision Making in a Danish Breast Cancer Screening Context
- ClinicalTrials.gov ID
- NCT05444725
- Acronym / sponsor ID
- 2016-051-000001, 2563
- Conditions
- Breast Cancer Female, Mammography Screening, Decision Making, Information Seeking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Self administered questionnaire
| Arm | Type | Receives |
|---|---|---|
| Stage of decision making | Other | Other: Stage of Decision MakingSame 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. |
| Choice framing | Other | Other: Choice framingSame 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. |
| Opportunity framing | Other | Other: Opportunity FramingSame 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. |
Who may qualify
- Ages
- 44 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women living in Denmark in this age group
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage 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. | Other | Stage of decision making |
| Choice 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. | Other | Choice framing |
| Opportunity 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. | Other | Opportunity framing |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 38703097Rossell EL, Bekker HL, Schonberg MA, Sonbo Kristiansen I, Borgquist S, Stovring H. Danish Women Make Decisions about Participation in Breast Cancer Screening prior to Invitation Information: An Online Survey Using Experimental Methods. Med Decis Making. 2024 Aug;44(6):674-688. doi: 10.1177/0272989X241248142. Epub 2024 May 4.
- Individual participant dataSharing planned: No. Not allowed by authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stage of Decision Making, Choice framing and Opportunity Framing in people with Breast Cancer Female and Mammography Screening, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.