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

NCT04607291 | Completed Phase 1 Results

• 4 other identifiers: I 63518NCI-2019-06075P30CA016056R41CA232824
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Prediction of Which CRC Screening Test is Most Acceptable

  Up to 12 months

Study Arms (1)

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.

Other: Community Health Service; Other: Survey Administration

Interventions

Community Health Service OTHER

Receive Witness CARES services

Health services research (Witness CARES services) Intervention

Survey Administration OTHER

Ancillary studies

Health services research (Witness CARES services) Intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Community Health Services

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

Kris.Attwood@roswellpark.org

716-845-1300

Study Officials

• Deborah Erwin

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 29, 2020
• Study Start: September 1, 2019
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2021
• Last Updated: August 12, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-08

Locations

US (1)