Testing Video Information About Mammography Screening

Breast Cancer Clinical Trial

Official title:

Testing Video Information About Mammography Screening in a Randomized Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424758
• Other study ID #: 2204MDJ
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: July 2020
• Source: University of Copenhagen
• Contact: Manja Jensen, MD
• Phone: 0045-35333123
• Email: madj[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants eligible for the study includes all men and women age 18-75.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Video information about mammography screening
A video informing about mammography screening
• Video information about smart energy systems
A video informing about smart energy systems

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Section of General Practice	Copenhagen	Capital

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One month
Secondary	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.	One month
Secondary	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.	One month