NCT06630442

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

October 4, 2024

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Changes in food safety knowledge

    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

    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

    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

    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

    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

    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

    Pre and post responses will be determined using score calculation and compared using ANOVA.

    From baseline up to 5 weeks post intervention

Study Arms (1)

Supportive care (food safety educational training)

EXPERIMENTAL

Patients attend a food safety educational training program over 50 minutes on study.

Other: Educational InterventionOther: Questionnaire Administration

Interventions

Attend a food safety educational training program

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Supportive care (food safety educational training)

Ancillary studies

Supportive care (food safety educational training)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Interventions

Early Intervention, EducationalEducational StatusMethods

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Sanja Ilic

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

February 21, 2022

Primary Completion

November 14, 2022

Study Completion

November 14, 2022

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations