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

Primary Purpose

Cancer Prevention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cancer control navigation (CNN)
General referral (usual care)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cancer control navigation (CNN) plus General referral (usual care)

General referral (usual care)

Arm Description

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.

Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
November 16, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT04638010
Brief Title
Increasing Breast, Cervical, and Colorectal Cancer Screening and HPV Vaccination Among Underserved Texans
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 16, 2011 (Actual)
Primary Completion Date
December 6, 2013 (Actual)
Study Completion Date
December 6, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Cancer Prevention Research Institute of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cancer control navigation (CNN) plus General referral (usual care)
Arm Type
Experimental
Arm Description
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.
Arm Title
General referral (usual care)
Arm Type
Active Comparator
Arm Description
Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
Intervention Type
Behavioral
Intervention Name(s)
Cancer control navigation (CNN)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General referral (usual care)
Intervention Description
Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
Primary Outcome Measure Information:
Title
Number of participants who complete needed cancer screening and prevention services
Description
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
Time Frame
one month after referral
Title
Number of participants who complete needed cancer screening and prevention services
Description
Cancer screening and prevention services include mammogram, Pap test, HPV vaccine, and/or colorectal cancer screening.
Time Frame
three months after referral

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Fernandez, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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