Colorectal CancerNCT05765214
Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes
A study testing Intervention Group (IG) in people with Colorectal Cancer and Type 2 Diabetes, run by Charles Drew University of Medicine and Science at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Type 2 Diabetes
- What is being tested?
- Intervention Group (IG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles R. Drew University
Los Angeles, California, 90059
About this study
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)?
Read more
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.
Read the 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.
- Conditions
- Colorectal Cancer, Type 2 Diabetes
- Being tested
- Intervention Group (IG)
- Keywords
- nutrition education
- Medical subject headings
- Colorectal Neoplasms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group (IG)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately and 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 May 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Kibe, DrPH, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765214
- Sponsor's protocol ID
- G003CSG1
- Status last verified
- Mar 2025
- First submitted
- 1 Mar 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05765214
- Acronym / sponsor ID
- G003CSG1
- Conditions
- Colorectal Cancer, Type 2 Diabetes
- Keywords
- nutrition education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Behavioral: Intervention Group (IG)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. |
| 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes type 2 diagnosis
- Age 35-75
- Any gender
- African American race (Hispanic or non-Hispanic)
- Hispanic ethnicity (any race)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group (IG)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) | Behavioural | Intervention Group (IG) |
Primary outcome
CRC-KPSS change and screening uptake
Time frame: immediately and 6-months post-intervention
Change in colorectal cancer knowledge, perceptions, self-care, and social norms; improved dietary quality and change in colorectal cancer screening uptake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Kibe, DrPH principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (IG) in people with Colorectal Cancer and Type 2 Diabetes, run by Charles Drew University of Medicine and Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC-KPSS change and screening uptake (time frame: immediately and 6-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.