Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia

Not Applicable

Completed

• Conditions: Behavior; Breast Cancer

• Registration Number: NCT05176405
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

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 Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-04
• Study Start: 2022-02-10
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
Measure the Theory of Planned Behavior (TPB) construct attitude, to predict Saudi females' intention to perform breast cancer early screening via mammogram	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.
Measure intention toward mammography	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
Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram	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.
Measure the TPB construct perceived behavioral control, to predict Saudi females' intention to perform breast cancer early screening via mammogram	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.
Compare the differences between EE viewers and non EE viewers in terms of issue involvement	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.
Compare the differences between EE viewers and none EE viewers in terms of perceived behavioral control.	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.
Compare the differences between EE viewers and none EE viewers in terms of attitude.	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States