Colorectal Cancer Screening
Conditions
Brief summary
This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.
Interventions
BEHAVIORALCommunity Health Advisor
Intervention arm participants will receive one 45-minute face-to-face meeting followed by two phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These educational activities will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. Community Health Advisors will take notes following each interaction to document the call length and call details. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text yes to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will include short messages about the benefits of colorectal cancer screening.
BEHAVIORALUsual care
Control arm participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Florida A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Participant will complete surveys and receive mailings and not know if they are in control arm or intervention arm.
Intervention model description
Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about colorectal cancer screening plus a resource list but no Community Health Advisor counseling support or cellphone / text contact like in the TUNE-UP Community Health Advisor intervention group.
Eligibility
Sex/Gender
ALL
Age
45 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. are 45 years to 64 years of age 2. self-identify as African American 3. have a working cellphone or telephone 4. are a resident of Florida 5. are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests \> 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years) 6. have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Exclusion criteria
1. under 45 years or over 64 years of age 2. do not self-identify as African American 3. do not have a working cellphone or telephone 4. not a resident of Florida 5. are adherent with colorectal cancer screening guidelines (i.e., stool-based tests \< 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or 6. have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Up to Date on Colorectal Cancer Screening | 12 months | The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (\> 1 year but \< 2 years ago; \> 2 years but not more than 5 years ago; or \> 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; \> 1 year but \< 5 years ago; \> 5 years but not more than 10 years ago; or \> 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a a year ago or less for the most recent stool blood test and less than 10 years ago for most recent colonoscopy are considered up to date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer Screening Knowledge Measure | 12 months | Participants are asked four multiple choice questions and 10 True/False questions to test knowledge about colorectal cancer and colorectal cancer screening. The range of the scale is 0-14. Each answer is scored as correct or incorrect. A score of 11 to 14 is considered high. A score of 7 to 10 is considered average. A score less than 7 is considered low. |
| Colorectal Cancer Screening Self-Efficacy Scale | 12 months | A validated 4-item measure of colorectal cancer screening self-efficacy (alpha = 0.82) asks participants to respond using a Likert scale about colorectal cancer screening test difficulty, finding time, ease of completing the test, and scheduling the test. Total scale scores range from 1 to 4. A score of 3 to 4 is considered low self-efficacy and a score of 1 to 2 is considered high self-efficacy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Community Health Advisor Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention
Community Health Advisor: Intervention arm participants will receive one 45-minute face-to-face meeting followed by two Community Health Advisor phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These colorectal cancer educational activities delivered by the Community Health Advisors will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer educational brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. Community Health Advisors will take notes following each interaction to document the call length, deviations from the script, and tone of the call. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text yes to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will have positive tones and include short messages about the benefits of colorectal cancer screening. | 58 |
| Usual Care Control group participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.
Usual care: Control arm participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing. | 57 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 9 |
Baseline characteristics
| Characteristic | Usual Care | Total | Community Health Advisor |
|---|---|---|---|
| Age, Continuous | 55.07 years STANDARD_DEVIATION 5.03 | 54.73 years STANDARD_DEVIATION 5.42 | 54.38 years STANDARD_DEVIATION 5.82 |
| Colorectal Cancer Screening Knowledge Measure | 9.79 units on a scale STANDARD_DEVIATION 2.09 | 9.41 units on a scale STANDARD_DEVIATION 2.21 | 9.03 units on a scale STANDARD_DEVIATION 2.27 |
| Colorectal Cancer Screening Self-Efficacy Scale | 1.92 units on a scale STANDARD_DEVIATION 0.55 | 1.95 units on a scale STANDARD_DEVIATION 0.55 | 1.99 units on a scale STANDARD_DEVIATION 0.54 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants | 115 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 57 participants | 115 participants | 58 participants |
| Sex: Female, Male Female | 26 Participants | 63 Participants | 37 Participants |
| Sex: Female, Male Male | 31 Participants | 52 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Up to Date on Colorectal Cancer Screening
The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (\> 1 year but \< 2 years ago; \> 2 years but not more than 5 years ago; or \> 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; \> 1 year but \< 5 years ago; \> 5 years but not more than 10 years ago; or \> 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a a year ago or less for the most recent stool blood test and less than 10 years ago for most recent colonoscopy are considered up to date.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Advisor | Number of Participants Up to Date on Colorectal Cancer Screening | 29 Participants |
| Usual Care | Number of Participants Up to Date on Colorectal Cancer Screening | 31 Participants |
Comparison: For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.p-value: <0.05Chi-squared
Secondary
Colorectal Cancer Screening Knowledge Measure
Participants are asked four multiple choice questions and 10 True/False questions to test knowledge about colorectal cancer and colorectal cancer screening. The range of the scale is 0-14. Each answer is scored as correct or incorrect. A score of 11 to 14 is considered high. A score of 7 to 10 is considered average. A score less than 7 is considered low.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Advisor | Colorectal Cancer Screening Knowledge Measure | 10.42 score on a scale | Standard Deviation 2.01 |
| Usual Care | Colorectal Cancer Screening Knowledge Measure | 9.88 score on a scale | Standard Deviation 1.61 |
Comparison: Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.p-value: <0.05t-test, 2 sided
Secondary
Colorectal Cancer Screening Self-Efficacy Scale
A validated 4-item measure of colorectal cancer screening self-efficacy (alpha = 0.82) asks participants to respond using a Likert scale about colorectal cancer screening test difficulty, finding time, ease of completing the test, and scheduling the test. Total scale scores range from 1 to 4. A score of 3 to 4 is considered low self-efficacy and a score of 1 to 2 is considered high self-efficacy.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Community Health Advisor | Colorectal Cancer Screening Self-Efficacy Scale | 1.86 score on a scale | Standard Deviation 0.56 |
| Usual Care | Colorectal Cancer Screening Self-Efficacy Scale | 1.98 score on a scale | Standard Deviation 0.61 |
Comparison: Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.p-value: <0.05t-test, 2 sided