Breast CancerNCT05176405
Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
A study testing You-Tube Video: Elissa's EE song in people with Breast Cancer and Behavior, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Behavior
- What is being tested?
- You-Tube Video: Elissa's EE song
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 14 Mar 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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Saudi Arabian
- female
Who cannot join
- Females 39 or younger
- females above age 69 years
- females who have had breast cancer
- females that have had risk-reducing bilateral mastectomies
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Behavior
- Being tested
- You-Tube Video: Elissa's EE song, Active Comparator: Standard of Care
- Keywords
- Mammogram, Prevention
- Medical subject headings
- Breast Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
You-Tube Video: Elissa's EE songBehavioural
Watch You-Tube video utilizing Entertainment-Education communication strategy.
Active Comparator: Standard of CareBehavioural
Reading materials containing information about early breast cancer screening in the form of infographics. Information is adopted from the Saudi Ministry of Health (MOH).
| Study group | Role | What they receive |
|---|---|---|
| Elissa's EE Song | Experimental | 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. Receives: Behavioral: You-Tube Video: Elissa's EE song |
| Standard of Care | Active comparator | 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. Receives: Behavioral: Active Comparator: Standard of Care |
| Control Group | No intervention | The third arm of this trial is the control group who will not be exposed to any preventative messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 1 Day
Secondary outcomes (7)
Measure the Theory of Planned Behavior (TPB) construct attitude, to predict Saudi females' intention to perform breast cancer early screening via mammogram
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.
Measured: 1 Day
Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram
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.
Measured: 1 day
Measure the TPB construct perceived behavioral control, to predict Saudi females' intention to perform breast cancer early screening via mammogram
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.
Measured: 1 day
Compare the differences between EE viewers and non EE viewers in terms of issue involvement
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.
Measured: 1 Day
Compare the differences between EE viewers and none EE viewers in terms of attitude.
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
Measured: 1 Day
Compare the differences between EE viewers and none EE viewers in terms of perceived behavioral control.
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.
Measured: 1 Day
Measure intention toward mammography
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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start10 Feb 2022
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
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.
- More trials run by Virginia Commonwealth UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanine Guidry, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176405
- Sponsor's protocol ID
- MCC-21-18633
- Other IDs
- HM20022255
- Status last verified
- Aug 2022
- First submitted
- 29 Oct 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there are no plans to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
- ClinicalTrials.gov ID
- NCT05176405
- Acronym / sponsor ID
- MCC-21-18633
- Conditions
- Breast Cancer, Behavior
- Keywords
- Mammogram, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 4 Jan 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elissa's EE Song | Experimental | Behavioral: You-Tube Video: Elissa's EE songParticipants 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. |
| Standard of Care | Active comparator | Behavioral: Active Comparator: Standard of CareParticipants 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. |
| Control Group | No intervention | –The third arm of this trial is the control group who will not be exposed to any preventative messages. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Saudi Arabian
- female
Key exclusion criteria (4 listed)
- Females 39 or younger
- females above age 69 years
- females who have had breast cancer
- females that have had risk-reducing bilateral mastectomies
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 |
|---|---|---|
| You-Tube Video: Elissa's EE songWatch You-Tube video utilizing Entertainment-Education communication strategy. | Behavioural | Elissa's EE Song |
| Active Comparator: Standard of CareReading materials containing information about early breast cancer screening in the form of infographics. Information is adopted from the Saudi Ministry of Health (MOH). | Behavioural | Standard of Care |
Primary outcome
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.
7 secondary outcomes
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
Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram
Time frame: 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
Compare the differences between EE viewers and non EE viewers in terms of issue involvement
Time frame: 1 Day
Compare the differences between EE viewers and none EE viewers in terms of attitude.
Time frame: 1 Day
Compare the differences between EE viewers and none EE viewers in terms of perceived behavioral control.
Time frame: 1 Day
Measure intention toward mammography
Time frame: 1 Day
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 2 Sep 2022.
- Individual participant dataSharing planned: No. Currently there are no plans to make individual participant data (IPD) available to other researchers.
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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.
Jeanine Guidry, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing You-Tube Video: Elissa's EE song in people with Breast Cancer and Behavior, run by Virginia Commonwealth University at 1 site in United States.
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 2 inclusion and 4 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 2 Sep 2022. 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 United States. 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?
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). 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 2 Sep 2022.