Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Cancer Screening, Decision Support, Navigation
Brief summary
This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.
Interventions
BEHAVIORALDecision Support & Navigation
BEHAVIORALStandard
Sponsors
Lehigh Valley Hospital
Fox Chase Cancer Center
Patient-Centered Outcomes Research Institute
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or Female * Self-identifies as being Hispanic or Latino * 50 to 75 years of age
Exclusion criteria
* Previous diagnosis of CRC * Up to date with CRC screening guidelines. * Personal history of inflammatory bowel disease * Personal history of polyps * Family history of CRC diagnosed before the age of 60 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Screening Adherence | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Screening Decision Stage | 6 months | 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. |
| Test Specific Screening Adherence | 12 Months | 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. |
| Screening Knowledge and Perceptions | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
2,720 study invitation letters sent to subjects from 5 practices that appeared to meet eligibility criteria based on medical records.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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.
Standard | 203 |
| 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.
Decision Support & Navigation | 197 |
| Total | 400 |
Baseline characteristics
| Characteristic | Standard | Decision Support & Navigation | Total |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 6.5 | 57.2 years STANDARD_DEVIATION 6.4 | 57.3 years STANDARD_DEVIATION 6.5 |
| Age, Customized Age (years) 50-59 | 140 Participants | 137 Participants | 277 Participants |
| Age, Customized Age (years) 60-69 | 47 Participants | 48 Participants | 95 Participants |
| Age, Customized Age (years) 70-79 | 16 Participants | 12 Participants | 28 Participants |
| CRC screening decision stage Decided not to do | 2 Participants | 2 Participants | 4 Participants |
| CRC screening decision stage Decided to do | 174 Participants | 166 Participants | 340 Participants |
| CRC screening decision stage Haven't decided | 20 Participants | 27 Participants | 47 Participants |
| CRC screening decision stage Not considering | 7 Participants | 2 Participants | 9 Participants |
| Education 2-yr Associates | 16 Participants | 19 Participants | 35 Participants |
| Education College Degree and above | 26 Participants | 17 Participants | 43 Participants |
| Education Completed Non-College/Business/Trade/Tech | 13 Participants | 8 Participants | 21 Participants |
| Education HS/GED | 58 Participants | 51 Participants | 109 Participants |
| Education Less than HS | 90 Participants | 102 Participants | 192 Participants |
| Employment Status Keeping House | 45 Participants | 45 Participants | 90 Participants |
| Employment Status Retired | 20 Participants | 14 Participants | 34 Participants |
| Employment Status Unable to Work/Disability | 53 Participants | 62 Participants | 115 Participants |
| Employment Status Working full-time | 44 Participants | 41 Participants | 85 Participants |
| Employment Status Working part-time | 41 Participants | 35 Participants | 76 Participants |
| Family Income $15,000-$29,000 | 37 Participants | 45 Participants | 82 Participants |
| Family Income $30,000-$45,999 | 18 Participants | 12 Participants | 30 Participants |
| Family Income $46,000-$59,999 | 3 Participants | 4 Participants | 7 Participants |
| Family Income Under $14,999 | 144 Participants | 136 Participants | 280 Participants |
| Family Income Unknown/Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Help Reading Materials from Doctor Always | 37 Participants | 32 Participants | 69 Participants |
| Help Reading Materials from Doctor Never | 94 Participants | 96 Participants | 190 Participants |
| Help Reading Materials from Doctor Often | 11 Participants | 10 Participants | 21 Participants |
| Help Reading Materials from Doctor Rarely | 16 Participants | 15 Participants | 31 Participants |
| Help Reading Materials from Doctor Sometimes | 45 Participants | 44 Participants | 89 Participants |
| Insurance Status Insured | 140 Participants | 141 Participants | 281 Participants |
| Insurance Status Uninsured | 58 Participants | 53 Participants | 111 Participants |
| Insurance Status Unknown/Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Language Most Spoken at Home Both | 26 Participants | 15 Participants | 41 Participants |
| Language Most Spoken at Home English | 14 Participants | 14 Participants | 28 Participants |
| Language Most Spoken at Home Spanish | 163 Participants | 168 Participants | 331 Participants |
| Language Score | 4.28 units on a scale STANDARD_DEVIATION 1.05 | 4.38 units on a scale STANDARD_DEVIATION 1 | 4.33 units on a scale STANDARD_DEVIATION 1.02 |
| Marital Status Divorced | 25 Participants | 26 Participants | 51 Participants |
| Marital Status Living as marreid | 10 Participants | 10 Participants | 20 Participants |
| Marital Status Married | 94 Participants | 78 Participants | 172 Participants |
| Marital Status Never married | 47 Participants | 53 Participants | 100 Participants |
| Marital Status Separated | 20 Participants | 13 Participants | 33 Participants |
| Marital Status Widowed | 7 Participants | 17 Participants | 24 Participants |
| Practice AIDS Activity Office | 10 Participants | 10 Participants | 20 Participants |
| Practice Centro de Salud | 40 Participants | 43 Participants | 83 Participants |
| Practice Lehigh Valley Family Health Center | 47 Participants | 45 Participants | 92 Participants |
| Practice Lehigh Valley Physician's Practice | 76 Participants | 74 Participants | 150 Participants |
| Practice Neighborhood Health Center of the Lehigh Valley | 30 Participants | 25 Participants | 55 Participants |
| Preferred CRC screening test Colonoscopy | 17 Participants | 22 Participants | 39 Participants |
| Preferred CRC screening test Even | 133 Participants | 142 Participants | 275 Participants |
| Preferred CRC screening test Stool Blood Test | 53 Participants | 33 Participants | 86 Participants |
| Race/Ethnicity, Customized Race Black/African American | 61 Participants | 57 Participants | 118 Participants |
| Race/Ethnicity, Customized Race Other | 42 Participants | 49 Participants | 91 Participants |
| Race/Ethnicity, Customized Race Unknown/Not Reported | 36 Participants | 22 Participants | 58 Participants |
| Race/Ethnicity, Customized Race White/Caucasian | 64 Participants | 69 Participants | 133 Participants |
| Region of Birth Caribbean- Dominican Republic and Cuba | 65 Participants | 63 Participants | 128 Participants |
| Region of Birth Caribbean- Puerto Rico | 81 Participants | 79 Participants | 160 Participants |
| Region of Birth Central America/Mexico | 19 Participants | 18 Participants | 37 Participants |
| Region of Birth South America | 14 Participants | 15 Participants | 29 Participants |
| Region of Birth United States | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Female | 118 Participants | 117 Participants | 235 Participants |
| Sex: Female, Male Male | 85 Participants | 80 Participants | 165 Participants |
| Years in the US 1-3 | 9 Participants | 12 Participants | 21 Participants |
| Years in the US 4-6 | 12 Participants | 13 Participants | 25 Participants |
| Years in the US 7-10 | 11 Participants | 18 Participants | 29 Participants |
| Years in the US Born in the US | 24 Participants | 22 Participants | 46 Participants |
| Years in the US Less than 1 year | 1 Participants | 0 Participants | 1 Participants |
| Years in the US More than 10 | 145 Participants | 132 Participants | 277 Participants |
| Years in the US Unknown | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 197 |
| other Total, other adverse events | 0 / 203 | 0 / 197 |
| serious Total, serious adverse events | 0 / 203 | 0 / 197 |
Outcome results
Primary
Overall Screening Adherence
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.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard | Overall Screening Adherence | Screened | 88 Participants |
| Standard | Overall Screening Adherence | Not Screened | 115 Participants |
| Decision Support & Navigation | Overall Screening Adherence | Not Screened | 44 Participants |
| Decision Support & Navigation | Overall Screening Adherence | Screened | 153 Participants |
p-value: <0.00195% CI: [3.08, 7.58]Regression, Logistic
Secondary
Change in Screening Decision Stage
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.
Time frame: 6 months
Population: Participants with complete baseline and endpoint survey data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard | Change in Screening Decision Stage | Forward Change | 61 Participants |
| Standard | Change in Screening Decision Stage | No Change | 52 Participants |
| Standard | Change in Screening Decision Stage | Backward Change | 10 Participants |
| Decision Support & Navigation | Change in Screening Decision Stage | Forward Change | 97 Participants |
| Decision Support & Navigation | Change in Screening Decision Stage | No Change | 23 Participants |
| Decision Support & Navigation | Change in Screening Decision Stage | Backward Change | 3 Participants |
p-value: <0.00195% CI: [2.55, 9.47]Regression, Logistic
Secondary
Screening Knowledge and Perceptions
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.
Time frame: 6 months
Population: Participants with complete baseline and 6-month survey data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard | Screening Knowledge and Perceptions | PHM: Response Efficacy | 4.5 units on a scale | Standard Deviation 0.7 |
| Standard | Screening Knowledge and Perceptions | PHM: Worries and Concerns | 3.1 units on a scale | Standard Deviation 1.1 |
| Standard | Screening Knowledge and Perceptions | PHM: Salience | 4.8 units on a scale | Standard Deviation 0.5 |
| Standard | Screening Knowledge and Perceptions | PHM: Social Support and Influence | 4.4 units on a scale | Standard Deviation 0.8 |
| Standard | Screening Knowledge and Perceptions | PHM: Susceptibility | 2.6 units on a scale | Standard Deviation 1 |
| Standard | Screening Knowledge and Perceptions | Knowledge Test | 4.7 units on a scale | Standard Deviation 1.8 |
| Standard | Screening Knowledge and Perceptions | Preventive Health Model (PHM) | 3.8 units on a scale | Standard Deviation 0.5 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | Knowledge Test | 4.6 units on a scale | Standard Deviation 2.1 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | Preventive Health Model (PHM) | 3.8 units on a scale | Standard Deviation 0.6 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | PHM: Salience | 4.7 units on a scale | Standard Deviation 0.6 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | PHM: Response Efficacy | 4.5 units on a scale | Standard Deviation 0.7 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | PHM: Susceptibility | 2.8 units on a scale | Standard Deviation 1 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | PHM: Worries and Concerns | 3.1 units on a scale | Standard Deviation 1.1 |
| Decision Support & Navigation | Screening Knowledge and Perceptions | PHM: Social Support and Influence | 4.4 units on a scale | Standard Deviation 0.9 |
p-value: 0.86295% CI: [-0.15, 0.13]Regression, Linear
p-value: 0.8895% CI: [-0.47, 0.55]Regression, Linear
Secondary
Test Specific Screening Adherence
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.
Time frame: 12 Months
Population: All randomized participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard | Test Specific Screening Adherence | None | 115 Participants |
| Standard | Test Specific Screening Adherence | Stool Blood Test | 76 Participants |
| Standard | Test Specific Screening Adherence | Colonoscopy | 12 Participants |
| Decision Support & Navigation | Test Specific Screening Adherence | None | 44 Participants |
| Decision Support & Navigation | Test Specific Screening Adherence | Stool Blood Test | 113 Participants |
| Decision Support & Navigation | Test Specific Screening Adherence | Colonoscopy | 40 Participants |
p-value: <0.001Regression, Multinomial
p-value: 0.00195% CI: [2.63, 6.7]Odds Ratio (OR)
p-value: 0.00195% CI: [4.13, 18.74]Odds Ratio (OR)