Promise Women Project

Cervical Cancer Clinical Trial

Official title:

PROMIS WOMAN Education Program : ImProving ceRvical Cancer preventiOn Methods Among Muslim AmerIcans WOMEN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862844
• Other study ID #: HM20024502_VCU
• Secondary ID: 3P30CA177558-10S
• Status: Completed
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: November 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to develop and test an intervention program to improve cervical cancer prevention among Muslim American women. The main questions the investigators aim to answer are: - Will the religiously tailored and culturally appropriate intervention program improve participants' knowledge and acceptance of cervical cancer prevention? - Is the intervention program feasible to conduct and acceptable to participants? Participants will be asked to: - Attend focus group sessions to provide input on the development of educational materials. - Complete pre- and post-intervention surveys to measure changes in knowledge and acceptance of cervical cancer prevention. - Engage in the intervention program, which includes education and experiential practice/communication skills training. - Provide feedback through satisfaction surveys. Researchers will compare participant outcomes before and after the intervention to assess its effectiveness. Additionally, the program's feasibility and acceptability will be evaluated based on enrollment rates, successful implementation, participant engagement, retention, and satisfaction.

Description:

This project involves creating special educational materials for Muslim women to learn about cervical cancer prevention. The investigators will engage in discussions with 10 Muslim women during dedicated group sessions to ensure the suitability of the materials. They will also seek input from Muslim religious leaders. Subsequently, they will conduct surveys before and after the program to assess the effectiveness of the materials in facilitating women's learning and comprehension of cervical cancer prevention. To determine its efficacy and acceptability, the investigators will implement the program with an additional 20 women and gather their feedback. The goal of this project is to promote the health and well-being of Muslim women by providing them with culturally and religiously sensitive information regarding cervical cancer prevention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria:
• Female Muslim individuals above 18 years old.
• Able to speak and understand English.
• Have not had a hysterectomy.
• Have not had a cervical cancer diagnosis.
• Willing to participate in the educational program and undergo cervical cancer screening.
• Physically well, able to give consent form.

Exclusion Criteria:

• Under age 18
• Not Muslim
• Unable to provide consent
• Participated in a pilot study

Related Conditions & MeSH terms

• Cervical Cancer
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Promise women project (Promote Cervical Cancer Prevention Methods Among Muslim Women in Virginia )
The Intervention Arm involves a 90-minute educational session tailored to Muslim women. They will learn about HPV infection risks, cervical cancer risks, and benefits of early screening and HPV vaccination. Discussions cover transmission, consequences, risk factors (behaviors, infections, family history), and importance of early detection. The session provides information on screening methods, check-ups, and HPV vaccine safety. Participants actively engage in discussions, ask questions, and share thoughts. The session empowers women with knowledge to make informed decisions about their health, promoting cervical cancer prevention.

Locations

Country	Name	City	State
United States	the Islamic center of Hampton	Hampton	Virginia
United States	the Peninsula Islamic Community Center	Hampton	Virginia
United States	Islamic center of Henrico-Alfalah	Henrico	Virginia
United States	the Islamic center of Richmond	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Mark Dignan, PhD	National Cancer Institute (NCI), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of women that attend the education session	Test the intervention program's acceptability as evidenced by session attendance	1 year
Primary	Number of women who undergo cervical cancer screening.	measured by tracking the number of women who schedule and attend	1 year
Secondary	Number of women enrolled	Test the intervention program's feasibility as evidenced by meeting enrollment targets	1 year