Trial Outcomes & Findings for Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening (NCT NCT04607291)

NCT ID: NCT04607291

Last Updated: 2021-08-12

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 183 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2021-08-12

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	183
Overall Study COMPLETED	183
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Health Services Research (Witness CARES Services) Intervention n=183 Participants 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
Age, Continuous	60.0 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	71 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants
Insurance Status Medicare/Medicaid	183 Participants n=5 Participants
Insurance Status non Medicare/Medicaid	0 Participants n=5 Participants
Insurance Status Uninsured	0 Participants n=5 Participants
Screening Eligibility Eligible	183 Participants n=5 Participants
Screening Eligibility non-Eligible	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

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

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.

Outcome measures

Measure	Health Services Research (Witness CARES Services) Intervention n=50 Participants 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
Change in Screening Metrics Definitely helped me complete my CRC screening · Yes	42 Participants
Change in Screening Metrics Definitely helped me complete my CRC screening · No	8 Participants
Change in Screening Metrics Needed Education or Help with At Home Test · Yes	37 Participants
Change in Screening Metrics Needed Education or Help with At Home Test · No	13 Participants
Change in Screening Metrics Needed Reminder Calls · Yes	33 Participants
Change in Screening Metrics Needed Reminder Calls · No	17 Participants
Change in Screening Metrics Needed Help understanding CRC Screening Tests · Yes	31 Participants
Change in Screening Metrics Needed Help understanding CRC Screening Tests · No	19 Participants
Change in Screening Metrics Likely to Refer a Friend to Witness Cares Services · Yes	45 Participants
Change in Screening Metrics Likely to Refer a Friend to Witness Cares Services · No	5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Health Services Research (Witness CARES Services) Intervention n=183 Participants 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
Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors Screened	56 Participants
Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors Not Screened	127 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Health Services Research (Witness CARES Services) Intervention n=183 Participants 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
Prediction of Which CRC Screening Test is Most Acceptable High Intent to Get Fit Test	112 Participants
Prediction of Which CRC Screening Test is Most Acceptable Low Intent to get Fit Test	71 Participants
Prediction of Which CRC Screening Test is Most Acceptable Unknown	2 Participants

Adverse Events

Health Services Research (Witness CARES Services) Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-1300

Email: Kris.Attwood@roswellpark.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place