Trial Title:
Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes
NCT ID:
NCT05765214
Condition:
Colorectal Cancer
Type 2 Diabetes
Conditions: Official terms:
Colorectal Neoplasms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Conditions: Keywords:
nutrition education
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Intervention Group (IG)
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)
Arm group label:
Intervention Group (IG)
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.
Criteria for 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
Gender:
All
Minimum age:
35 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Charles R. Drew University
Address:
City:
Los Angeles
Zip:
90059
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lucy Kibe, DrPH
Phone:
484-340-0793
Email:
lucykibe@cdrewu.edu
Contact backup:
Last name:
Talegria Brown, PhD
Phone:
310-343-9877
Email:
talegriabrown@cdrewu.edu
Start date:
May 1, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Charles Drew University of Medicine and Science
Agency class:
Other
Source:
Charles Drew University of Medicine and Science
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05765214
