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

NCT05765214 | Active Not Recruiting

• 1 other identifier: G003CSG1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Type 2 Diabetes

Keywords

nutrition education

Outcome Measures

Primary Outcomes (1)

• 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

  immediately and 6-months post-intervention

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

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.

Behavioral: Intervention Group (IG)

Usual Care (UC)

NO INTERVENTION

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

Interventions

Intervention Group (IG) BEHAVIORAL

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)

Intervention Group (IG)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles R. Drew University

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Diabetes Mellitus, Type 2

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; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lucy Kibe, DrPH

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)