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Cancer Prevention Education for Breast and Cervical Cancer (SEMM2 Trial)

N/A

Recruiting

Led By Lara Savas, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Have a current or prior cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between baseline and end of study (about 9 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce breast & cervical cancer in underserved Latinas through education, navigation, screening & HPV vaccination.

Who is the study for?

This trial is for Latina women in certain Texas counties who are over 40 with no mammogram in the last 2 years, aged 21-65 with no Pap test in the past 3 years, or aged 18-26 (up to age 45 if recommended) needing HPV vaccination. Pregnant women or those with a current/past cancer diagnosis cannot join.

What is being tested?

The study aims to improve early detection and prevention of breast and cervical cancer among underserved Latinas through educational programs and helping them navigate healthcare services to get screened for cancer and receive HPV vaccinations.

What are the potential side effects?

Since this trial focuses on education and navigation assistance rather than medical treatments, there are no direct side effects from interventions like drugs or surgery. However, participants may experience stress or anxiety related to screening procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with cancer before or currently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between baseline and end of study (about 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between baseline and end of study (about 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and between baseline and end of study (about 9 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of women 18-26 years who initiate (complete first dose) of the HPV vaccine

Number of women 21-65 years who complete Pap test screening

Number of women 40 and older who complete mammogram screening

Secondary study objectives

Number of women 18-26 years who receive dose 2 of HPV vaccine

Number of women 18-26 years who receive dose 3 of HPV vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Zoom Delivered Breast and Cervical Cancer Behavioral InterventionExperimental Treatment2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Group II: Telephone Delivered Breast and Cervical Cancer Behavioral InterventionExperimental Treatment2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Group III: In-Person Delivered Breast and Cervical Cancer Behavioral InterventionExperimental Treatment2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Education

2017

N/A

~4790

Navigation to clinic

2016

N/A

~8270