Trial Outcomes & Findings for Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations (NCT NCT01853774)
NCT ID: NCT01853774
Last Updated: 2021-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
419 participants
Primary outcome timeframe
Attendance at the community educational class and 8 weeks beyond to attendance at a clinic.
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
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.
Tailored navigation
|
Control
Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
162
|
|
Overall Study
COMPLETED
|
211
|
134
|
|
Overall Study
NOT COMPLETED
|
46
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Navigation From Community to Clinic to Promote CRC Screening in Underserved Populations
Baseline characteristics by cohort
| Measure |
Tailored Navigation
n=211 Participants
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.
Tailored navigation
|
Control
n=134 Participants
Participants in the control arm will receive phone calls to support data collection and tracking, but not receive tailored messages
|
Total
n=345 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
158 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
137 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
211 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Tailored Navigation
n=211 Participants
Tailored Navigation participants received tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol was used to guide individuals community sites into primary care clinics.
|
Control
n=134 Participants
Control group:participants received phone calls to support data collection and tracking, but not tailored messages, to check if they attended a clinic appointment.
|
|---|---|---|
|
Primary Outcome is Clinic Attendance
|
64 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Tailored Navigation
n=64 Participants
Tailored Navigation participants received tailored navigation phone calls to assist them with barriers in making a clinic appointment or attending the clinic. The tailored navigation intervention protocol was used to guide individuals community sites into primary care clinics.
|
Control
n=17 Participants
Control group:participants received phone calls to support data collection and tracking, but not tailored messages, to check if they attended a clinic appointment.
|
|---|---|---|
|
The Secondary Outcome is Participant Completion of a CRC Screening Test.
|
56 Participants
|
14 Participants
|
Adverse Events
Tailored Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor, College of Nursing and Health Innovation
Arizona State University
Phone: 6024960740
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place