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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Cervical Cancer, Breast Cancer

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Navigation to clinic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Person Delivered Breast and Cervical Cancer Behavioral Intervention<br>Community health worker deliver behavioral education and referrals to low-cost services. Deliver in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. | Behavioral: Education<br>* 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).<br>Behavioral: Navigation to clinic<br>* 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.<br>|
| Experimental: Telephone Delivered Breast and Cervical Cancer Behavioral Intervention<br>Community health worker deliver behavioral education and referrals to low-cost services. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics. | Behavioral: Education<br>* 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).<br>Behavioral: Navigation to clinic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer prevention, Breast cancer detection, HPV vaccination