Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations

NCT01853774 | Completed Results

• 2 other identifiers: 5R01CA162393-021207008010
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness of a two-phase intervention using "community-to-clinic navigators" to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, to track effects of the intervention on completion of colorectal cancer (CRC) screening in clinics. A cost-effectiveness analysis will lay the foundation for further implementation and dissemination research. Aim 1: Test effectiveness of community group education + tailored navigation versus community group education only in increasing clinic attendance among low-income, multicultural Arizona residents, aged 50 to 75 yrs. Hypothesis 1: Individuals receiving group education classes + tailored navigation will show higher rates of clinic attendance than those receiving only group education. \* As a separate critical step for those who make clinic appointments, the investigators will examine the effect on follow through to screening, using initial group assignment as a control variable in analysis. Patients making clinic appointments will receive referral for screening and tailored navigation as usual care. Aim 2: Track outcomes of the Phase I intervention on CRC screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic. Hypothesis 2: Individuals receiving group classes and tailored navigation during Phase I will have higher rates of CRC screening test completion than those receiving classes only, (however this outcome will be primarily due to clinic attendance). Aim 3: Determine the cost-effectiveness of each phase of the interventions on increasing CRC screening completion among low-income, multicultural Arizona residents aged 50 to 75 years. Exploratory Aim 4: Examine the levels of program dissemination from community to clinic to final screenings using the RE-AIM model. Research Question 2: What is the degree of Reach, Efficacy, Adoption, Implementation, and Maintenance of the community-to-clinic navigation, and clinic-to-screening outcomes?

Conditions

Colorectal Cancer

Keywords

Tailored navigation; Tailored messages

Outcome Measures

Primary Outcomes (1)

• Primary Outcome is Clinic Attendance

  Track outcomes of the Phase I intervention on colorectal cancer (CRC) screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.

  Attendance at the community educational class and 8 weeks beyond to attendance at a clinic.

Secondary Outcomes (1)

• The Secondary Outcome is Participant Completion of a CRC Screening Test.

  At 3- and 6-months post clinic visit, we will collect screening data from patient self-report and medical chart reviews.

Study Arms (2)

Tailored Navigation

EXPERIMENTAL

Participants will receive tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol will be used to guide individuals from an especially hard-to-reach, multicultural, and underinsured population into primary care clinics and, subsequently, track the effects of this intervention through a clinic navigation program to complete Colorectal cancer screening.

Behavioral: Tailored navigation

Control

NO INTERVENTION

Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages

Interventions

Tailored navigation BEHAVIORAL

Also known as: Tailored messages

Tailored Navigation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants will be aged 50-75,
• speak either English or Spanish,
• live in low-income neighborhoods (including a range of race and ethnicity),
• are due for CRC screening,
• may be at average or high risk for CRC,
• either will not identify a regular clinic they attend or will be registered (or identify) with one of the clinic systems engaged in our study. Those who do identify a clinic home, however, will also be encouraged to join the study as long as they are due for screening.

You may not qualify if:

• Individuals who are compliant with CRC screening guidelines will not be eligible.
• While we will not intentionally exclude any specific racial/ethnic group, our study materials are offered in Spanish and English. As such, anyone who does cannot speak, read, and write English or Spanish will not be eligible to participate in the study.

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator
• University of Arizona: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85048, United States

Location

Related Publications (3)

• Kim JH, Menon U. Pre- and postintervention differences in acculturation, knowledge, beliefs, and stages of readiness for mammograms among Korean American women. Oncol Nurs Forum. 2009 Mar;36(2):E80-92. doi: 10.1188/09.onf.e80-e92.

  PMID: 19273397 BACKGROUND

• Herman PM, Bucho-Gonzalez J, Menon U, Szalacha LA, Larkey L. Cost-Effectiveness of Community-to-Clinic Tailored Navigation for Colorectal Cancer Screening in an Underserved Population: Economic Evaluation Alongside a Group-Randomized Trial. Am J Health Promot. 2022 May;36(4):678-686. doi: 10.1177/08901171211068454. Epub 2022 Jan 27.

  PMID: 35081762 DERIVED

• Menon U, Szalacha LA, Kue J, Herman PM, Bucho-Gonzalez J, Lance P, Larkey L. Effects of a Community-to-Clinic Navigation Intervention on Colorectal Cancer Screening Among Underserved People. Ann Behav Med. 2020 Apr 20;54(5):308-319. doi: 10.1093/abm/kaz049.

  PMID: 31676898 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Professor, College of Nursing and Health Innovation
• Organization: Arizona State University

linda.larkey@asu.edu

6024960740

Study Officials

• LInda K Larkey, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: March 31, 2017
• Last Updated: May 11, 2021
• Results First Posted: January 18, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)