A Phase 1 interventional study of Community Health Service and Survey Administration in Colorectal Carcinoma, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-12.
Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Health services research
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 183 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Community Health Service · Other: Survey Administration
Receive Witness CARES services
Ancillary studies
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
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
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
| Milestone | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Started | 183 |
| Completed | 183 |
| Not completed | 0 |
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.
| Participants | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Definitely helped me complete my CRC screening — Yes | 42 |
| Definitely helped me complete my CRC screening — No | 8 |
| Needed Education or Help with At Home Test — Yes | 37 |
| Needed Education or Help with At Home Test — No | 13 |
| Needed Reminder Calls — Yes | 33 |
| Needed Reminder Calls — No | 17 |
| Needed Help understanding CRC Screening Tests — Yes | 31 |
| Needed Help understanding CRC Screening Tests — No | 19 |
| Likely to Refer a Friend to Witness Cares Services — Yes | 45 |
| Likely to Refer a Friend to Witness Cares Services — No | 5 |
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).
| Participants | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Screened | 56 |
| Not Screened | 127 |
Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable
| Participants | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| High Intent to Get Fit Test | 112 |
| Low Intent to get Fit Test | 71 |
| Unknown | 2 |
Collected over 30 days post contact with navigator.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Services Research (Witness CARES Services) Intervention | 0/183 (0%) | 0/183 (0%) | 0/183 (0%) |
| Age, Continuous(years) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Mean | 60.0 ± 5.1 |
| Sex: Female, Male(Participants) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Female | 118 |
| Male | 65 |
| Race (NIH/OMB)(Participants) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 71 |
| White | 87 |
| More than one race | 0 |
| Unknown or Not Reported | 22 |
| Region of Enrollment(participants) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| United States | 183 |
| Insurance Status(Participants) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Medicare/Medicaid | 183 |
| non Medicare/Medicaid | 0 |
| Uninsured | 0 |
| Screening Eligibility(Participants) | Health Services Research (Witness CARES Services) Intervention |
|---|---|
| Eligible | 183 |
| non-Eligible | 0 |
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Roswell Park Cancer Institute