Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans

Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans: A Collaboration With the United Way's 2-1-1 Program

This study involves a partnership between UTHealth School of Public Health and the Texas 2-1-1 service, which is a helpline connecting low-income and minority callers with a number of needed services. The purpose of this study is to evaluate the effectiveness of a prevention program in which a phone navigator intervention designed to connect 2-1-1 helpline callers to evidence-based screening and prevention services including mammography, Pap test screening, colorectal cancer screening, and HPV vaccination.

Study Overview

• Status: Completed
• Conditions: Cancer Prevention
• Intervention / Treatment: Behavioral: Cancer control navigation (CNN); Behavioral: General referral (usual care)

• Study Type: Interventional
• Enrollment (Actual): 1554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• callers to 2-1-1
• consents to participate,
• English or Spanish speaking
• not in a crisis (e.g., disaster-related 2-1-1 call or personal crisis)

Exclusion Criteria:

• not English or Spanish speaking
• in crisis (e.g., disaster-related call or personal crisis)
• calling on behalf of another client and not for self

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cancer control navigation (CNN) plus General referral (usual care); Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs. Additionally, Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only.	Behavioral: Cancer control navigation (CNN); Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only.; Behavioral: General referral (usual care); Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
Active Comparator: General referral (usual care); Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.	Behavioral: General referral (usual care); Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete needed cancer screening and prevention services	Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.	one month after referral
Number of participants who complete needed cancer screening and prevention services	Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.	three months after referral

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: Maria E Fernandez, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2011
• Primary Completion (Actual): December 6, 2013
• Study Completion (Actual): December 6, 2013

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HSC-SPH-10-0241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No