Salud en Mis Manos - Breast and Cervical Cancer Prevention and Early Detection - Expansion 1

Breast Cancer Clinical Trial

— SEMM1  

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: Completed

Administrative data

• NCT number: NCT06082505
• Other study ID #: HSC-SPH-16-0159
• Secondary ID: PP160047
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: May 29, 2019

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate implementation of a community-based prevention project aimed at increasing 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 Salud en Mis Manos community health worker-delivered breast and cervical cancer screening promotion 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 (March 2017 - May 2019). The investigators also describe the implementation of the program during a longer time period (November 2016 - May 2019).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8262
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Self identifies as Hispanic or Latina

• Lives in Texas

• Breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older

• Cervical cancer screening group: have not had a Pap test in the past 3 years and are 21 years of age and older

• HPV vaccination group: are women 21-26 years of age, and have not initiated the HPV vaccine series

• Age limit for breast cancer screening group: 40 years and older

• Age limit for cervical cancer screening group (Pap test): 21 years and older

• Age limit for HPV vaccination group: 21-26 years

Exclusion Criteria:

• Current pregnancy

• 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 1 hour breast and cervical cancer prevention education session delivered with support of electronic presentations. For phone education, trained project staff or Community Health Workers (CHWs) will deliver telephone-based education as an alternative to group education session for women who missed scheduled session twice (education materials would be printed and mailed).
• Navigation to clinic
Continue telephone based navigation tailored to participants' barriers using the 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 years and older who complete mammogram screening	Among women 40 years and older that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.	Between baseline and end of study (about 9 months)
Primary	Number of women 21-65 years old who complete Pap test screening	Among women 21 - 65 years old that have not had a Pap test in the past three years, enrolled in the program and completed baseline and follow-up surveys.	Between baseline and end of study (about 9 months)
Primary	Number of women 21-26 years old who initiate their HPV vaccination series.	Among women 21-26 years old that have not yet initiated their HPV vaccination series, enrolled in the program and completed baseline and follow-up surveys.	between baseline and end of study (about 9 months)
Secondary	Number of participants who received the second dose of HPV vaccine	Among women that have not had their second HPV vaccination dose, enrolled in the program and completed baseline and follow-up surveys.	between baseline and end of study (about 9 months)
Secondary	Number of participants who received the third dose of HPV vaccine	Among women 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)
Secondary	Number of participants who received a clinical breast exam	Among women that have not had a mammogram in the past two years, enrolled in the program and completed baseline and follow-up surveys.	between baseline and end of study (about 9 months)