Hematopoietic and Lymphatic System NeoplasmNCT06630442
Food Safety Educational Training Program to Improve Food Safety Knowledge and Behaviors in Cancer Patients Receiving Treatment
A study testing Educational Intervention and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Educational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Being tested
- Educational Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend a food safety educational training program
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (food safety educational training) | Experimental | Patients attend a food safety educational training program over 50 minutes on study. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in food safety knowledge
Pre and post responses will be determined using score calculation and compared using analysis of variance (ANOVA).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to 5 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start21 Feb 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanja Ilic, Ohio State University Comprehensive Cancer Center
- Investigators
- Sanja Ilic, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630442
- Sponsor's protocol ID
- OSU-21049
- Other IDs
- NCI-2024-06192
- Status last verified
- May 2025
- First submitted
- 4 Oct 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Educational Food Safety Intervention for Cancer Patients Receiving Treatment
- ClinicalTrials.gov ID
- NCT06630442
- Acronym / sponsor ID
- OSU-21049
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 8 Oct 2024 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (food safety educational training) | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationPatients attend a food safety educational training program over 50 minutes on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend a food safety educational training program | Other | Supportive care (food safety educational training) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (food safety educational training) |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- The JameslineLink provided by the sponsor.
Related trials for Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 3
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
Multiple Myeloma
Active, not recruitingPhase 3
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD1775 as a Potential Targeted Treatment in Cancers With BRCA Genetic Changes (MATCH-Subprotocol Z1I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies
Not yet recruitingPhase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
Core Binding Factor Alpha Subunits, Hematologic Neoplasms
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.
Sanja Ilic principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in food safety knowledge (time frame: From baseline up to 5 weeks post intervention). The study lists 7 primary outcomes in all. 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 15 May 2025.