Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
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|ClinicalTrials.gov Identifier: NCT01853774|
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : January 18, 2020
Last Update Posted : May 11, 2021
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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?
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Tailored navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations|
|Actual Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Tailored Navigation
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
Other Name: Tailored messages
No Intervention: Control
Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
- Primary Outcome is Clinic Attendance [ Time Frame: Attendance at the community educational class and 8 weeks beyond to attendance at a clinic. ]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.
- The Secondary Outcome is Participant Completion of a CRC Screening Test. [ Time Frame: At 3- and 6-months post clinic visit, we will collect screening data from patient self-report and medical chart reviews. ]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).
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|Ages Eligible for Study:||50 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
Phase I Inclusion criteria:
- 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.
Phase II Inclusion criteria:
• Participants who keep their clinic appointment from Phase I will be enrolled in the study by clinic navigators and the Phase I inclusion criteria (above) will be re-confirmed.
• 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853774
|United States, Arizona|
|Arizona State University|
|Phoenix, Arizona, United States, 85048|
|Principal Investigator:||LInda K Larkey, PhD||Arizona State University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Arizona State University|
|Other Study ID Numbers:||
5R01CA162393-02 ( U.S. NIH Grant/Contract )
1207008010 ( Other Identifier: Arizona State University IRB )
|First Posted:||May 15, 2013 Key Record Dates|
|Results First Posted:||January 18, 2020|
|Last Update Posted:||May 11, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases