Clinical trial · Interventional
Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tailored navigation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tailored Navigation
- description
- 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.
- interventionNames
- Behavioral: Tailored navigation
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
Primary outcomes (1)
- measure
- Primary Outcome is Clinic Attendance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: • 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.
References
Publications (3)
- BACKGROUNDKim 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
- DERIVEDHerman 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
- DERIVEDMenon 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