Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia

NCT05176405 | Completed

• 2 other identifiers: MCC-21-18633HM20022255
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Behavior

Keywords

Mammogram; Prevention

Outcome Measures

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.

  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 Outcomes (7)

• Measure the Theory of Planned Behavior (TPB) construct attitude, to predict Saudi females' intention to perform breast cancer early screening via mammogram

  1 Day

• Measure the TPB construct, subject norm, to predict Saudi females' intention to perform breast cancer early screening via mammogram

  1 day

• Measure the TPB construct perceived behavioral control, to predict Saudi females' intention to perform breast cancer early screening via mammogram

  1 day

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

  1 Day

• Compare the differences between EE viewers and none EE viewers in terms of attitude.

  1 Day

Study Arms (3)

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.

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.

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.

Interventions

You-Tube Video: Elissa's EE song BEHAVIORAL

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

Elissa's EE Song

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).

Standard of Care

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Saudi Arabian
• female

You may not qualify if:

• Females 39 or younger
• females above age 69 years
• females who have had breast cancer
• females that have had risk-reducing bilateral mastectomies

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeanine Guidry, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: January 4, 2022
• Study Start: February 10, 2022
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)