- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06630442
Food Safety Educational Training Program to Improve Food Safety Knowledge and Behaviors in Cancer Patients Receiving Treatment
May 12, 2025 updated by: Sanja Ilic, Ohio State University Comprehensive Cancer Center
Efficacy of an Educational Food Safety Intervention for Cancer Patients Receiving Treatment
This clinical trial evaluates the impact of a food safety educational training program on food safety knowledge and behaviors in cancer patients receiving treatment.
Cancer treatments, such as chemotherapy, can put patients at risk for foodborne infections and despite this risk, it has been reported that patients do not receive any food safety counseling until they are already experiencing low white blood cell counts.
A food safety educational training program may help cancer patients make better choices of low-risk foods and prepare foods safely.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. Evaluate the efficacy of a food safety education intervention for cancer patients.
OUTLINE:
Patients attend a food safety educational training program over 50 minutes on study.
After completion of study intervention, patients are followed up at 5 weeks.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants must be at least 18 years of age
- Able to fluently read and converse in English (though it does not have to be their first language)
- All participants must be diagnosed with cancer, any stage, and be receiving some form of treatment at the aforementioned facilities
- Informed consent must be obtained from each patient prior to participation in any aspect of the study
Exclusion Criteria:
- Patients who do not meet these criteria or are not willing or are unable to give informed consent, will be excluded from this study
- Patients with prescribed dietary limitations or currently on neutropenic diet unrelated to this study will not be included
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive care (food safety educational training)
Patients attend a food safety educational training program over 50 minutes on study.
|
Ancillary studies
Attend a food safety educational training program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in food safety knowledge
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using analysis of variance (ANOVA).
|
From baseline up to 5 weeks post intervention
|
|
Changes in attitudes
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
|
Changes in risk perception
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
|
Changes in self-efficacy
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
|
Changes in behaviors
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
|
Changes in food acquisition practices
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
|
Changes in high-risk food consumption
Time Frame: From baseline up to 5 weeks post intervention
|
Pre and post responses will be determined using score calculation and compared using ANOVA.
|
From baseline up to 5 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sanja Ilic, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2022
Primary Completion (Actual)
November 14, 2022
Study Completion (Actual)
November 14, 2022
Study Registration Dates
First Submitted
October 4, 2024
First Submitted That Met QC Criteria
October 4, 2024
First Posted (Actual)
October 8, 2024
Study Record Updates
Last Update Posted (Actual)
May 15, 2025
Last Update Submitted That Met QC Criteria
May 12, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-21049
- NCI-2024-06192 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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