NCT04638010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,554

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2013

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

November 16, 2020

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

EXPERIMENTAL

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)Behavioral: General referral (usual care)

General referral (usual care)

ACTIVE COMPARATOR

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)

Interventions

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.

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Fernandez ME, Savas LS, Atkinson JS, Ricks KB, Ibekwe LN, Jackson I, Castle PE, Jobe D, Vernon SW. Evaluation of a 2-1-1 Telephone Navigation Program to Increase Cancer Control Behaviors: Results From a Randomized Controlled Trial. Am J Health Promot. 2022 Sep;36(7):1083-1093. doi: 10.1177/08901171211041276. Epub 2022 May 5.

Study Officials

  • Maria E Fernandez, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Center for Health Promotion and Prevention Research

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

February 16, 2011

Primary Completion

December 6, 2013

Study Completion

December 6, 2013

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations