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Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes

Primary Purpose

Colorectal Cancer, Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group (IG)
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring nutrition education

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diabetes type 2 diagnosis Age 35-75 Any gender African American race (Hispanic or non-Hispanic) Hispanic ethnicity (any race) Have had at least one visit to KCHC in the past 2 years Have complete address and telephone number in the electronic health records. Although USPSTF and American Cancer Society screening guidelines recommend starting screening at age 45, our intervention will include patients age 35-44 due to the reported incidence of CRC at an earlier age among diabetic patients 3 Exclusion Criteria: History of colorectal cancer History of colectomy History of colonic polyps (ICD-10 Z86.010) History of radiation treatment for another cancer (abdominal prostate, skin etc) History of Crohn's disease Ulcerative colitis Cystic fibrosis <10 year life expectancy Cognitive impairment or inability to comprehend or provide consent to participate in the study Being institutionalized Participating in another diet program

Sites / Locations

  • Charles R. Drew University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (IG)

Usual Care (UC)

Arm Description

Participants randomized to the IG will receive a customized patient-centered, culturally appropriate education program. Patients randomized to the IG will participate in eight (8) education sessions. A booklet with colorectal cancer education and nutrition education will be developed and print materials given to the participants to use as a workbook.

Patients randomized to UC group will continue to receive care at the clinic without any intervention from the study team.

Outcomes

Primary Outcome Measures

CRC-KPSS change and screening uptake
Change in colorectal cancer knowledge, perceptions, self-care, and social norms; improved dietary quality and change in colorectal cancer screening uptake

Secondary Outcome Measures

Full Information

First Posted
March 1, 2023
Last Updated
March 10, 2023
Sponsor
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT05765214
Brief Title
Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes
Official Title
Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this observation study is to deliver an education program designed to increase knowledge of colorectal cancer prevention and nutrition education in minorities with Type 2 diabetes. The main questions it aims to answer are: What factors are associated with colorectal cancer screening among patients with type 2 diabetes? Will implementing a customized patient-centered, culturally appropriate colorectal cancer education, and nutrition education program reduce the risk for colorectal cancer among patients with type 2 diabetes? What is the impact of a patient-centered, culturally appropriate colorectal cancer education, and nutrition education intervention program on colorectal cancer screening and dietary indices among patients with type 2 diabetes compared to outcomes with patients who do not receive the intervention (usual care)? Participants randomized to the intervention group will: receive a customized patient-centered, culturally appropriate education program participate in eight (8) education sessions be given booklet with colorectal cancer education and nutrition education to use as a workbook Researchers will compare colorectal cancer knowledge, perceptions, self-care, and social norms scores and dietary indices of the intervention group to the control group immediately and 6-months post intervention to see if the education program increased colorectal cancer knowledge and screenings and changes in dietary habits.
Detailed Description
Colorectal cancer (CRC) is the second leading cause of death in the United States (US)1. In 2019, over 140,000 adults were newly diagnosed with CRC and over 50,000 died.Furthermore, colorectal cancer disproportionately affects minorities and individuals with diabetes. Research has proven that interventions can increase cancer screening rates and improve lifestyle choices that put minorities at higher risk for developing colorectal cancer and diabetes. This proposal will assess the impact of a colorectal cancer and nutrition education program among minority patients with type 2 diabetes by carrying out three aims. Aim 1: Examine factors associated with colorectal cancer screening among patients with type 2 diabetes. The aim of this objective is to identify factors associated with colorectal cancer screening among patients with type 2 diabetes by comparing patients who have received screening verses those who have not. It is hypothesized that patients with type 2 diabetes who have not met colorectal cancer screening guidelines have low socioeconomic status (income 100% below poverty level, lack health insurance, speak language other than English, less education); have fewer provider visits; are not married; and have poor health and health risk factors (uncontrolled diabetes, multiple comorbidities (3+), BMI>30, depression, smoking and alcohol use history) compared to patients with type 2 diabetes who have met screening guidelines. Aim 2:Implement a customized patient-centered, culturally appropriate colorectal cancer education, and nutrition education program aimed at reducing the risk for colorectal cancer among patients with type 2 diabetes at a community health center. The aim of this objective is to deliver a customized patient-centered, culturally appropriate education program on (i) colorectal cancer (knowledge, perceptions, self-care, social norms; and colorectal cancer screening) and (ii) healthy nutrition based on dietary guidelines for colorectal cancer risk reduction and complementary to type 2 diabetes dietary guidelines, among minority patients at a community health center. Aim 3: Assess the impact of a patient-centered, culturally appropriate colorectal cancer education, and nutrition education intervention program on colorectal cancer screening and dietary indices among patients with type 2 diabetes; and compare outcomes with patients who do not receive the intervention (usual care). The first objective of this aim is to measure change in knowledge and perceptions about colorectal cancer, and colorectal cancer screening immediately and 6 months post intervention. It is hypothesized that patients in the intervention group will have (1) higher knowledge and higher perception scores compared to those receiving usual care and (2) 25% higher rate of colorectal cancer screening 12 months after the intervention, compared to those receiving usual care. The aim's second objective is to measure the change in dietary indices associated with colorectal cancer (fiber, fruits, vegetables, calcium, red meat, processed meat, fat, and alcohol consumption)and overall diet quality immediately and 6 months post intervention. It is hypothesized that patients who receive a patient-centered culturally appropriate nutrition education intervention program will be more likely to meet dietary guidelines for fiber, fruits, vegetables, calcium, red meat, processed meat, fat, and alcohol consumption and overall diet quality compared those receiving usual care. A five-phase study will be carried out at the Kedren Community Health Center (KCHC) in South Los Angeles that had a patient population of 48.4% African American and 47.5% Hispanic in 2020. Surveys and electronic health record will be used to recruit patients and provide study data. The impact of an education program will be assessed by comparing an intervention verses a control group, and change in knowledge, perceptions, and behaviors related to nutrition and colorectal cancer screening over time. A major anticipated outcome is increasing the rate of colorectal cancer screening among diabetic patients at KCHC. Another outcome is improving dietary choices among study participants. One or more manuscripts will be prepared for publication and findings will be presented at professional conferences and community forums.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Type 2 Diabetes
Keywords
nutrition education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Participants randomized to the IG will receive a customized patient-centered, culturally appropriate education program. Patients randomized to the IG will participate in eight (8) education sessions. A booklet with colorectal cancer education and nutrition education will be developed and print materials given to the participants to use as a workbook.
Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
Patients randomized to UC group will continue to receive care at the clinic without any intervention from the study team.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Intervention Description
In general, the education will cover: (i) Colorectal cancer - knowledge, perceptions, self-care, and social norms (CRC-KPSS): Knowledge; Perceptions (perceived susceptibility, perceived severity, perceived benefits, perceived barriers); Self-care; and Social norms; and information on colorectal cancer screening (ii) Healthy nutrition colorectal for cancer risk reduction and complementary to diabetes guideline (increasing consumption of fiber, fruits, vegetables, whole grains, and calcium; reducing red and processed meat, fat, added sugars and alcohol)
Primary Outcome Measure Information:
Title
CRC-KPSS change and screening uptake
Description
Change in colorectal cancer knowledge, perceptions, self-care, and social norms; improved dietary quality and change in colorectal cancer screening uptake
Time Frame
immediately and 6-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diabetes type 2 diagnosis Age 35-75 Any gender African American race (Hispanic or non-Hispanic) Hispanic ethnicity (any race) Have had at least one visit to KCHC in the past 2 years Have complete address and telephone number in the electronic health records. Although USPSTF and American Cancer Society screening guidelines recommend starting screening at age 45, our intervention will include patients age 35-44 due to the reported incidence of CRC at an earlier age among diabetic patients 3 Exclusion Criteria: History of colorectal cancer History of colectomy History of colonic polyps (ICD-10 Z86.010) History of radiation treatment for another cancer (abdominal prostate, skin etc) History of Crohn's disease Ulcerative colitis Cystic fibrosis <10 year life expectancy Cognitive impairment or inability to comprehend or provide consent to participate in the study Being institutionalized Participating in another diet program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy Kibe, DrPH
Phone
484-340-0793
Email
lucykibe@cdrewu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Talegria Brown, PhD
Phone
310-343-9877
Email
talegriabrown@cdrewu.edu
Facility Information:
Facility Name
Charles R. Drew University
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Kibe, DrPH
Phone
484-340-0793
Email
lucykibe@cdrewu.edu
First Name & Middle Initial & Last Name & Degree
Talegria Brown, PhD
Phone
310-343-9877
Email
talegriabrown@cdrewu.edu

12. IPD Sharing Statement

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Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes

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