Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04607291
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 183
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Carcinoma	Other: Community Health Service; Other: Survey Administration	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: May 14, 2020
• Actual Study Completion Date: May 14, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Other: Community Health Service; Receive Witness CARES services; Other: Survey Administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Deborah Erwin, Roswell Park Cancer Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 25, 2019

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT04607291
• Other Study ID Numbers: I 63518; NCI-2019-06075; I 63518; P30CA016056; R41CA232824
• First Posted: Oct 29, 2020
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
Period Title: Overall Study
STARTED	183
COMPLETED	183
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
Overall Participants	183
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (5.1)
Sex: Female, Male (Count of Participants)
Female	118 64.5%
Male	65 35.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 1.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	71 38.8%
White	87 47.5%
More than one race	0 0%
Unknown or Not Reported	22 12%
Region of Enrollment (participants) [Number]
United States	183 100%
Insurance Status (Count of Participants)
Medicare/Medicaid	183 100%
non Medicare/Medicaid	0 0%
Uninsured	0 0%
Screening Eligibility (Count of Participants)
Eligible	183 100%
non-Eligible	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Screening Metrics
Description	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

Outcome Measure Data

Analysis Population Description

There were a total of n=56 patients that received screening, of those patients, n=50 completed satisfaction surveys.

Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
Measure Participants	50
Yes	42 23%
No	8 4.4%
Yes	37 20.2%
No	13 7.1%
Yes	33 18%
No	17 9.3%
Yes	31 16.9%
No	19 10.4%
Yes	45 24.6%
No	5 2.7%

2. Primary Outcome

Title	Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
Measure Participants	183
Screened	56 30.6%
Not Screened	127 69.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Health Services Research (Witness CARES Services) Intervention
	Comments
	Type of Statistical Test	Other
	Comments	A logistic regression model was used to identify factors associated with screening.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC. Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry. AUC: 0.71

3. Secondary Outcome

Title	Prediction of Which CRC Screening Test is Most Acceptable
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
Measure Participants	183
High Intent to Get Fit Test	112 61.2%
Low Intent to get Fit Test	71 38.8%
Unknown	2 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Health Services Research (Witness CARES Services) Intervention
	Comments	Evaluating factors associated with high intent of getting a Fit test.
	Type of Statistical Test	Other
	Comments	A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC. Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score. AUC: 0.80

Adverse Events

Time Frame	30 days post contact with navigator.
Arm/Group Title	Health Services Research (Witness CARES Services) Intervention
Arm/Group Description	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
All Cause Mortality
	Health Services Research (Witness CARES Services) Intervention
	Affected / at Risk (%)	# Events
Total	0/183 (0%)
Serious Adverse Events
	Health Services Research (Witness CARES Services) Intervention
	Affected / at Risk (%)	# Events
Total	0/183 (0%)
Other (Not Including Serious) Adverse Events
	Health Services Research (Witness CARES Services) Intervention
	Affected / at Risk (%)	# Events
Total	0/183 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.