Colorectal Carcinoma
Conditions
Brief summary
This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.
Detailed description
PRIMARY OBJECTIVES: I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients. II. Develop an algorithm for predicting CRC screening outcomes following intervention services. OUTLINE: Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests. After completion of study, patients are followed up periodically.
Interventions
Receive Witness CARES services
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years) * Medicaid or Medicaid/Medicare subscribers * Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program
Exclusion criteria
* Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded * Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening * Participants symptomatic for CRC will be excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Screening Metrics | Up to 12 months | After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program. Below are responses to basic follow-up questions. |
| Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors | Up to 12 months | A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening. The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome. The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of Which CRC Screening Test is Most Acceptable | Up to 12 months | Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Services Research (Witness CARES Services) Intervention Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.
Community Health Service: Receive Witness CARES services
Survey Administration: Ancillary studies | 183 |
| Total | 183 |
Baseline characteristics
| Characteristic | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 5.1 |
| Insurance Status Medicare/Medicaid | 183 Participants |
| Insurance Status non Medicare/Medicaid | 0 Participants |
| Insurance Status Uninsured | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 183 participants |
| Screening Eligibility Eligible | 183 Participants |
| Screening Eligibility non-Eligible | 0 Participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 183 |
| other Total, other adverse events | 0 / 183 |
| serious Total, serious adverse events | 0 / 183 |
Outcome results
Primary
Change in Screening Metrics
After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program. Below are responses to basic follow-up questions.
Time frame: Up to 12 months
Population: There were a total of n=56 patients that received screening, of those patients, n=50 completed satisfaction surveys.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Definitely helped me complete my CRC screening | Yes | 42 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Definitely helped me complete my CRC screening | No | 8 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Education or Help with At Home Test | Yes | 37 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Education or Help with At Home Test | No | 13 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Reminder Calls | Yes | 33 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Reminder Calls | No | 17 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Help understanding CRC Screening Tests | Yes | 31 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Needed Help understanding CRC Screening Tests | No | 19 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Likely to Refer a Friend to Witness Cares Services | Yes | 45 Participants |
| Health Services Research (Witness CARES Services) Intervention | Change in Screening Metrics | Likely to Refer a Friend to Witness Cares Services | No | 5 Participants |
Primary
Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening. The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome. The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions).
Time frame: Up to 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Witness CARES Services) Intervention | Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors | Screened | 56 Participants |
| Health Services Research (Witness CARES Services) Intervention | Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors | Not Screened | 127 Participants |
Secondary
Prediction of Which CRC Screening Test is Most Acceptable
Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable
Time frame: Up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services Research (Witness CARES Services) Intervention | Prediction of Which CRC Screening Test is Most Acceptable | High Intent to Get Fit Test | 112 Participants |
| Health Services Research (Witness CARES Services) Intervention | Prediction of Which CRC Screening Test is Most Acceptable | Low Intent to get Fit Test | 71 Participants |
| Health Services Research (Witness CARES Services) Intervention | Prediction of Which CRC Screening Test is Most Acceptable | Unknown | 2 Participants |
Comparison: Evaluating factors associated with high intent of getting a Fit test.