Trial Outcomes & Findings for Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients (NCT NCT02272244)
NCT ID: NCT02272244
Last Updated: 2025-05-04
Results Overview
The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
12 months
Results posted on
2025-05-04
Participant Flow
2,720 study invitation letters sent to subjects from 5 practices that appeared to meet eligibility criteria based on medical records.
2,320 were excluded * 98 contact not attempted (recruitment goals met or known ineligible) * 504 were determined up to date on screening * 182 were ineligible for other reasons * 256 refused * 717 were unable to be contacted * 563 were wrong numbers
Participant milestones
| Measure |
Standard
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
|
Decision Support & Navigation
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
197
|
|
Overall Study
COMPLETED
|
203
|
197
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
Baseline characteristics by cohort
| Measure |
Standard
n=203 Participants
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
Standard
|
Decision Support & Navigation
n=197 Participants
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Decision Support \& Navigation
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
57.2 years
STANDARD_DEVIATION 6.4 • n=107 Participants
|
57.3 years
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Age, Customized
Age (years) · 50-59
|
140 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
277 Participants
n=206 Participants
|
|
Age, Customized
Age (years) · 60-69
|
47 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Age, Customized
Age (years) · 70-79
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
64 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
61 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
42 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Not Reported
|
36 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Marital Status
Married
|
94 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Marital Status
Living as marreid
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Marital Status
Separated
|
20 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
7 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Marital Status
Never married
|
47 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Education
Less than HS
|
90 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Education
HS/GED
|
58 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Education
Completed Non-College/Business/Trade/Tech
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Education
2-yr Associates
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Education
College Degree and above
|
26 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Employment Status
Working full-time
|
44 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Employment Status
Working part-time
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Employment Status
Keeping House
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Employment Status
Unable to Work/Disability
|
53 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Employment Status
Retired
|
20 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Family Income
Under $14,999
|
144 Participants
n=99 Participants
|
136 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
|
Family Income
$15,000-$29,000
|
37 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Family Income
$30,000-$45,999
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Family Income
$46,000-$59,999
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Family Income
Unknown/Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Insurance Status
Insured
|
140 Participants
n=99 Participants
|
141 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Insurance Status
Uninsured
|
58 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Insurance Status
Unknown/Not Reported
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Help Reading Materials from Doctor
Never
|
94 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Help Reading Materials from Doctor
Rarely
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Help Reading Materials from Doctor
Sometimes
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Help Reading Materials from Doctor
Often
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Help Reading Materials from Doctor
Always
|
37 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Practice
Centro de Salud
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Practice
Lehigh Valley Family Health Center
|
47 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Practice
Lehigh Valley Physician's Practice
|
76 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Practice
AIDS Activity Office
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Practice
Neighborhood Health Center of the Lehigh Valley
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Years in the US
Less than 1 year
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Years in the US
1-3
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Years in the US
4-6
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Years in the US
7-10
|
11 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Years in the US
More than 10
|
145 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
277 Participants
n=206 Participants
|
|
Years in the US
Born in the US
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Years in the US
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Birth
United States
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Region of Birth
Caribbean- Puerto Rico
|
81 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Region of Birth
Caribbean- Dominican Republic and Cuba
|
65 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Region of Birth
Central America/Mexico
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Birth
South America
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Language Most Spoken at Home
Spanish
|
163 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
|
Language Most Spoken at Home
Both
|
26 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Language Most Spoken at Home
English
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Language Score
|
4.28 units on a scale
STANDARD_DEVIATION 1.05 • n=99 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 1.00 • n=107 Participants
|
4.33 units on a scale
STANDARD_DEVIATION 1.02 • n=206 Participants
|
|
Preferred CRC screening test
Stool Blood Test
|
53 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Preferred CRC screening test
Even
|
133 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
275 Participants
n=206 Participants
|
|
Preferred CRC screening test
Colonoscopy
|
17 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
CRC screening decision stage
Decided not to do
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
CRC screening decision stage
Not considering
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
CRC screening decision stage
Haven't decided
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
CRC screening decision stage
Decided to do
|
174 Participants
n=99 Participants
|
166 Participants
n=107 Participants
|
340 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.
Outcome measures
| Measure |
Standard
n=203 Participants
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
|
Decision Support & Navigation
n=197 Participants
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
|
|---|---|---|
|
Overall Screening Adherence
Screened
|
88 Participants
|
153 Participants
|
|
Overall Screening Adherence
Not Screened
|
115 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with complete baseline and endpoint survey data
At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.
Outcome measures
| Measure |
Standard
n=123 Participants
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
|
Decision Support & Navigation
n=123 Participants
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
|
|---|---|---|
|
Change in Screening Decision Stage
Forward Change
|
61 Participants
|
97 Participants
|
|
Change in Screening Decision Stage
No Change
|
52 Participants
|
23 Participants
|
|
Change in Screening Decision Stage
Backward Change
|
10 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: All randomized participants.
Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.
Outcome measures
| Measure |
Standard
n=203 Participants
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
|
Decision Support & Navigation
n=197 Participants
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
|
|---|---|---|
|
Test Specific Screening Adherence
None
|
115 Participants
|
44 Participants
|
|
Test Specific Screening Adherence
Stool Blood Test
|
76 Participants
|
113 Participants
|
|
Test Specific Screening Adherence
Colonoscopy
|
12 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with complete baseline and 6-month survey data.
Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.
Outcome measures
| Measure |
Standard
n=122 Participants
SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.
|
Decision Support & Navigation
n=123 Participants
DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
|
|---|---|---|
|
Screening Knowledge and Perceptions
Preventive Health Model (PHM)
|
3.8 units on a scale
Standard Deviation 0.5
|
3.8 units on a scale
Standard Deviation 0.6
|
|
Screening Knowledge and Perceptions
PHM: Salience
|
4.8 units on a scale
Standard Deviation 0.5
|
4.7 units on a scale
Standard Deviation 0.6
|
|
Screening Knowledge and Perceptions
PHM: Response Efficacy
|
4.5 units on a scale
Standard Deviation 0.7
|
4.5 units on a scale
Standard Deviation 0.7
|
|
Screening Knowledge and Perceptions
PHM: Susceptibility
|
2.6 units on a scale
Standard Deviation 1.0
|
2.8 units on a scale
Standard Deviation 1.0
|
|
Screening Knowledge and Perceptions
PHM: Worries and Concerns
|
3.1 units on a scale
Standard Deviation 1.1
|
3.1 units on a scale
Standard Deviation 1.1
|
|
Screening Knowledge and Perceptions
PHM: Social Support and Influence
|
4.4 units on a scale
Standard Deviation 0.8
|
4.4 units on a scale
Standard Deviation 0.9
|
|
Screening Knowledge and Perceptions
Knowledge Test
|
4.7 units on a scale
Standard Deviation 1.8
|
4.6 units on a scale
Standard Deviation 2.1
|
Adverse Events
Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Decision Support & Navigation
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
Ronald Myers(Priniciple Investigator)
Thomas Jefferson Universiy
Phone: 215-5034085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place