Breast CancerNCT04424758
Testing Video Information About Mammography Screening
A study testing Video information about mammography screening and Video information about smart energy systems in people with Breast Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Video information about mammography screening and Video information about smart energy systems
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jun 2020to 30 Jul 2020
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants eligible for the study includes all men and women age 18-75.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen, Section of General Practice
Copenhagen, Capital, 1014
Manja D Jensen, MD, 0045-35333123, madj@sund.ku.dk
John Brodersen, MD, phd, jobr@sund.ku.dk
About this study
Official title: Testing Video Information About Mammography Screening in a Randomized Design
This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.
Read the detailed description
This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.
The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.
Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.
- Conditions
- Breast Cancer
- Being tested
- Video information about mammography screening, Video information about smart energy systems
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video information about mammography screeningOther
A video informing about mammography screening
Video information about smart energy systemsOther
A video informing about smart energy systems
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence. Receives: Other: Video information about mammography screening |
| Control group | Placebo comparator | Receives information about energy systems through a video. The video does not contain any information related to mammography screening. Receives: Other: Video information about smart energy systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice: proportion of participants in favor of mammography screening
The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.
Measured: One month
Secondary outcomes (2)
Response duration: time
Response duration is registered for all participants in the online survey. Mean response duration will be calculated in both the intervention arm and control arm.
Measured: One month
Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start16 Jun 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- See protocol
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manja Dahl Jensen, University of Copenhagen
- Investigators
- Manja Jensen, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424758
- Sponsor's protocol ID
- 2204MDJ
- Status last verified
- Jul 2020
- First submitted
- 28 May 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is completed, access to study data will be provided by the PI on request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Video Information About Mammography Screening in a Randomized Design
- ClinicalTrials.gov ID
- NCT04424758
- Acronym / sponsor ID
- 2204MDJ
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 11 Jun 2020 (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.
This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.
Detailed description
This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.
The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.
Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- See protocol
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Video information about mammography screeningReceives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence. |
| Control group | Placebo comparator | Other: Video information about smart energy systemsReceives information about energy systems through a video. The video does not contain any information related to mammography screening. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants eligible for the study includes all men and women age 18-75.
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 |
|---|---|---|
| Video information about mammography screeningA video informing about mammography screening | Other | Intervention group |
| Video information about smart energy systemsA video informing about smart energy systems | Other | Control group |
Primary outcome
Choice: proportion of participants in favor of mammography screening
Time frame: One month
The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.
2 secondary outcomes
Response duration: time
Time frame: One month
Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: Yes. When the study is completed, access to study data will be provided by the PI on request.
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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.
Manja Jensen, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video information about mammography screening and Video information about smart energy systems in people with Breast Cancer, run by University of Copenhagen 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manja Jensen, MD (0045-35333123, madj@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice: proportion of participants in favor of mammography screening (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.