Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05765214 |
| Other study ID # |
G003CSG1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2023 |
| Est. completion date |
June 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Charles Drew University of Medicine and Science |
| Contact |
Lucy Kibe, DrPH |
| Phone |
484-340-0793 |
| Email |
lucykibe[@]cdrewu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
