Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 2

Breast Cancer Clinical Trial

— SEMM2  

Official title:

A Community Based Program to Increase Breast and Cervical Cancer Screening and HPV Vaccination to Reduce the Impact of Breast and Cervical Cancer Among Latinas.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082882
• Other study ID #: HSC-SPH-19-0775
• Secondary ID: PP190061
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Lara Savas, PhD
• Phone: 713-500-9638
• Email: lara.staub[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.

Description:

This is an evaluation of the implementation of the Salud en Mis Manos program. The investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and HPV vaccination using a one-group pre-post study design (2022-2024). The investigators also describe the implementation of the program during a longer time period (2020-.2024).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: July 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Primarily residing in the Gulf Coast & Lower Rio Grande Valley county areas (or other counties in Texas)
• Women 40 years of age and older with no mammogram in the past 2 years
• Women 21-65 years, with no Pap test in the past 3 years
• Women aged 18-26 years, who have not initiated or completed the HPV vaccine series, and through age 45 years if Advisory Committee on Immunization Practices (ACIP) recommends the FDA-approved age expansion for HPV vaccination for older individuals.

Exclusion Criteria:

• Current pregnancy
• Have a current or prior cancer diagnosis

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Education
Education will be delivered in person in a group education setting or individually by phone. Group education will include a ~1-hour breast and cervical cancer prevention education session delivered with the support of electronic presentations (e.g. PowerPoint presentation ) which will include updated prevention recommendations, such as HPV vaccination recommendations for young adults. For phone education, trained project staff or CHWs will deliver telephone-based education as an alternative to group education sessions for women who missed a scheduled session twice (education materials would be printed and mailed).
• Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the SEMM Cancer Prevention Plan of Action to support, problem solve, assist, and provide reminders to increase utilization of clinic services.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women 40 and older who complete mammogram screening	Among women 40 and older enrolled in the program who have not had a mammogram in the past 2 years at baseline and who self-report mammogram screening completed on follow-up surveys	Between baseline and end of study (about 9 months)
Primary	Number of women 21-65 years who complete Pap test screening	Among women 21-65 years enrolled in the program who have not had a Pap test screening in the past three years at baseline, and who self-report Pap or HPV screening on follow-up surveys.	Between baseline and end of study (about 9 months)
Primary	Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine	Among women 18-26 years that have not had any HPV vaccination at baseline, enrolled in the program and self-report first HPV vaccine completed on follow-up surveys.	Between baseline and end of study (about 9 months)
Secondary	Number of women 18-26 years who receive dose 2 of HPV vaccine	Among women 18-26 years that have not had their second HPV vaccination dose at baseline, enrolled in the program and self-report completed 2 doses on follow-up surveys.	between baseline and end of study (about 9 months)
Secondary	Number of women 18-26 years who receive dose 3 of HPV vaccine	Among women 18-26 years that have not had their third HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.	between baseline and end of study (about 9 months)