Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Primary Purpose
Colorectal Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Fecal Immunochemical Test
Patient Navigation
Questionnaire Administration
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Age 45 years of age or older
- No prior history of colorectal cancer or colon polyps
- No first-degree family history of colorectal cancer who were diagnosed under age 60
- No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)
- Have not undergone a colonoscopy in the last 5 years
- Have not had a fecal immunochemical test (FIT) test within the last year
- Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area
Sites / Locations
- Mayo Clinic in ArizonaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening (FIT, education, questionnaire, patient navigation)
Arm Description
Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.
Outcomes
Primary Outcome Measures
Colorectal cancer disparities seen in people of color and minority populations
Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447923
Brief Title
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Official Title
Colorectal Cancer Screening in Black and Underserved Communities in the Phoenix Metro Area: Addressing Disparities in Cancer Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial studies disparities involving colorectal cancer prevention and screening in Black and underserved communities in the Phoenix metropolitan area. The Black community is disproportionately impacted by colorectal cancer, with the highest rate of any racial/ethnic group in the United States. There are complex reasons behind these disparities, largely related to socioeconomic factors and healthcare access. Providing access to free, home-based fecal immunochemical testing (FIT), colorectal screening education, and appropriate follow-up to predominantly Black community-based organizations and underserved communities may help to close this gap.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program for this community in Phoenix.
OUTLINE:
Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.
After completion of screening, participants with a positive FIT test are followed up at 2 and 4 weeks after initial outreach to assure participants have received adequate follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening (FIT, education, questionnaire, patient navigation)
Arm Type
Experimental
Arm Description
Participants receive free FIT tests in conjunction with education on colorectal cancer screening. Participants undergo self-collect FIT and mail the sample to Mayo Clinic Lab for processing. Participants also complete a questionnaire about colorectal cancer screening and healthcare. Participants receive FIT test results through Mayo Clinic nursing support and participants with a positive test are followed up by a patient navigator to discuss next steps and consultation with a gastroenterologist to review their results.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Undergo education for colorectal cancer screening
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test
Other Intervention Name(s)
FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test
Intervention Description
Undergo FIT testing
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Undergo patient navigation for positive FIT results
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire about colorectal cancer screening and healthcare
Primary Outcome Measure Information:
Title
Colorectal cancer disparities seen in people of color and minority populations
Description
Evaluate patient navigation to address colorectal cancer disparities seen in people of color, minority populations, and establish an ongoing colorectal cancer screening outreach program.
Time Frame
Up to study completion, up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 45 years of age or older
No prior history of colorectal cancer or colon polyps
No first-degree family history of colorectal cancer who were diagnosed under age 60
No current gastrointestinal (GI) or rectal symptoms (such as rectal bleeding)
Have not undergone a colonoscopy in the last 5 years
Have not had a fecal immunochemical test (FIT) test within the last year
Participants that attend 4 predominantly African American churches within the Phoenix Community and extend the study opportunity as feasible to other underserved communities in the Phoenix Metro area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana M Kling
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Juliana M. Kling, M.D.
12. IPD Sharing Statement
Learn more about this trial
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
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