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Completed

NCT Number: NCT05176405

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.

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Key information

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

You-Tube Video: Elissa's EE song

Behavioral

Watch You-Tube video utilizing Entertainment-Education communication strategy.

Active Comparator: Standard of Care

Behavioral

Reading materials containing information about early breast cancer screening in the form of infographics. Information is adopted from the Saudi Ministry of Health (MOH).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Compare the differences between EE viewers and non EE viewers in terms of issue involvement

    Time frame: 1 Day

    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.

  5. 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

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Using Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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