- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05176405
Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
August 30, 2022 updated by: Virginia Commonwealth University
Using Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
This clinical trial aims to test if Elissa's Entertainment-Education (EE) song can influence Saudi females' intention to perform breast cancer early screening via mammogram.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will be guided by a scarcely applied theoretical model that integrates the issue involvement concept into the Theory of Planned Behavior (TPB) to test the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among Saudi females after exposure to EE message.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- 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 Locations
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Virginia
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Richmond, Virginia, United States, 23284
- Virginia Commonwealth University
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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
Ages Eligible for Study
40 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Saudi Arabian
- female
Exclusion Criteria:
- Females 39 or younger
- females above age 69 years
- females who have had breast cancer
- females that have had risk-reducing bilateral mastectomies
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elissa's EE Song
Participants will have to click on the watch button to start the YouTube video as it is without manipulation.
Right after exposure, the first and second arms will be asked if they have seen either of the presented materials before.
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Watch You-Tube video utilizing Entertainment-Education communication strategy.
|
Active Comparator: Standard of Care
Participants will be assigned to read general infographic messages adopted from the Saudi Ministry of Health (MOH) in the breast cancer early screening context in Arabic/English.
Right after exposure, the first and second arms will be asked if they have seen either of the presented materials before.
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Reading materials containing information about early breast cancer screening in the form of infographics.
Information is adopted from the Saudi Ministry of Health (MOH).
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No Intervention: Control Group
The third arm of this trial is the control group who will not be exposed to any preventative messages.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among Saudi females after exposure to EE message.
Time Frame: 1 Day
|
Right after exposure to the intervention, the first and second arms will be asked if they have seen either of the presented materials before.
During the statistical analysis, the researcher will control for those who indicate seeing either of these materials.
The three arms will be given one validated questionnaire that measures issue involvement (INV) and Theory of Planned Behaviors (TPB's) constructs.
Issue involvement will be measured using a personal involvement inventory scale.
Issue involvement will be answered on a 7-point Likert scale ranging from 1 (Not at all) to 7 (Very much) with six items: important, relevant, interesting, means a lot to me, valuable, and involving.
The minimum value is 6 and the maximum value is 42.
High scores mean a high level of involvement with mammography.
|
1 Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the Theory of Planned Behavior (TPB) construct attitude, to predict Saudi females' intention to perform breast cancer early screening via mammogram
Time Frame: 1 Day
|
Attitude toward mammography will be measured directly by asking participants to indicate their level of agreement with the following three statements 1) Getting a mammogram in the next two years would be good; 2) Getting a mammogram in the next two years would be useful; and 3) Getting a mammogram in the next two years would be safe.
The scores will be added together to measure Saudi females' attitudes toward mammography The minimum value is 3, and the maximum value is 15.
A high score indicates a more positive attitude towards mammography.
|
1 Day
|
Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram
Time Frame: 1 day
|
Subject norms will be measured utilizing the Theory of Planned Behavior Questionnaire.
Subjective norms will be measured directly by asking participants to indicate their level of agreement with the following three statements 1) Most people who are important to me think I should get a mammogram in the next two years; 2) Most people who are important to me expect me to get a mammogram in the next two years; and 3) Most people who are important to me would approve of me getting a mammogram in the next two years The minimum value is 3 and the maximum value is 15.
A high score indicates a more positive attitude towards mammography.
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1 day
|
Measure the TPB construct perceived behavioral control, to predict Saudi females' intention to perform breast cancer early screening via mammogram
Time Frame: 1 day
|
Perceived behavioral control will be measured directly by asking participants to indicate their level of agreement with the following three statements: 1) Whether or not I get a mammogram in the next two years is entirely up to me; 2) I believe it is feasible to get a mammogram in the next two years; and 3) I am confident that if I wanted I would be able to get a mammogram in the next two years.
The scores will be added together to measure how much control do Saudi females have to perform mammography in the next two years.
The expected minimum value is 3, while the maximum value is 15.
A high score implies higher behavioral control toward mammography.
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1 day
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Compare the differences between EE viewers and non EE viewers in terms of issue involvement
Time Frame: 1 Day
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Involvement is measured utilizing the results from the personal involvement inventory scale (PII) scale.
Issue involvement will be answered on a 7-point Likert scale ranging from 1 (Not at all) to 7 (Very much) with six items: important, relevant, interesting, means a lot to me, valuable, and involving.
The expected minimum value is 6, while the maximum value of 42 with high scores implies a high level of involvement with the mammography.
|
1 Day
|
Compare the differences between EE viewers and none EE viewers in terms of attitude.
Time Frame: 1 Day
|
Attitude is measured directly by asking participants to indicate their level of agreement with the following three statements 1) Getting a mammogram in the next two years would be good; 2) Getting a mammogram in the next two years would be useful; and 3) Getting a mammogram in the next two years would be safe.
The scores will be added together to measure Saudi females' attitudes toward mammography.
The expected minimum value is 3, while the maximum value is 15.
A high score means a more positive attitude toward mammography
|
1 Day
|
Compare the differences between EE viewers and none EE viewers in terms of perceived behavioral control.
Time Frame: 1 Day
|
Perceived behavioral control will be measured directly by asking participants to indicate their level of agreement with the following three statements: 1) Whether or not I get a mammogram in the next two years is entirely up to me; 2) I believe it is feasible to get a mammogram in the next two years; and 3) I am confident that if I wanted I would be able to get a mammogram in the next two years.
The scores will be added together to measure how much control do Saudi females have to perform mammography in the next two years.
The expected minimum value is 3, while the maximum value is 15.
A high score implies higher behavioral control toward mammography.
|
1 Day
|
Measure intention toward mammography
Time Frame: 1 Day
|
Intention toward mammography will be measured directly by asking participants to indicate their level of agreement with the following three statements 1) I plan to get a mammogram in the next two years; 2) I want to get a mammogram in the next two years; 3) I will try to get a mammogram in the next two years.
The scores will be added together to measure Saudi females' intention to perform mammography in the next two years.
The expected minimum value is 3, while the maximum value is 15.
A high score reflects stronger intentions toward mammography
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeanine Guidry, PhD, Virginia Commonwealth University
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)
February 10, 2022
Primary Completion (Actual)
March 14, 2022
Study Completion (Actual)
March 14, 2022
Study Registration Dates
First Submitted
October 29, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
January 4, 2022
Study Record Updates
Last Update Posted (Actual)
September 2, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MCC-21-18633
- HM20022255 (Other Identifier: Virginia Commonwealth University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Currently there are no plans to make individual participant data (IPD) available to other researchers.
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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