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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06075 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 63518 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| R41CA232824 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (Witness CARES services) Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Service | Other | Receive Witness CARES services |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Erwin | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | There were a total of n=56 patients that received screening, of those patients, n=50 completed satisfaction surveys. | Posted | Count of Participants | Participants | Up to 12 months |
|
30 days post contact with navigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 716-845-1300 | Kris.Attwood@roswellpark.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2019 | Jul 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003153 | Community Health Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Survey Administration | Other | Ancillary studies |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Insurance Status | Count of Participants | Participants |
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| Screening Eligibility | Does the participant meet the requirements/guidelines for CRC screening? | Count of Participants | 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). | Posted | Count of Participants | Participants | Up to 12 months |
|
|
|
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| 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 | Posted | Count of Participants | Participants | Up to 12 months |
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| 0 |
| 183 |
| 0 |
| 183 |
| 0 |
| 183 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Title | Measurements |
|---|---|
|