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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT04638010
• Collaborator: Cancer Prevention Research Institute of Texas (Other)
• Enrollment: 1,554
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 46.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Prevention	Behavioral: Cancer control navigation (CNN); Behavioral: General referral (usual care)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1554 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans: A Collaboration With the United Way's 2-1-1 Program
• Actual Study Start Date: Feb 16, 2011
• Actual Primary Completion Date: Dec 6, 2013
• Actual Study Completion Date: Dec 6, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of participants who complete needed cancer screening and prevention services [one month after referral]

   Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.

2. Number of participants who complete needed cancer screening and prevention services [three months after referral]

   Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• Cancer Prevention Research Institute of Texas

Investigators

• Principal Investigator: Maria E Fernandez, PhD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria E Fernandez, Professor and Director, Center for Health Promotion and Prevention Research, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04638010
• Other Study ID Numbers: HSC-SPH-10-0241
• First Posted: Nov 20, 2020
• Last Update Posted: Nov 20, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Nov 20, 2020