Chemotherapy ExposureNCT06919653
Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses
A study testing The Workplace program to Improve the Safe Handling of hazardous drugs (WISH) in people with Chemotherapy Exposure and Handling Guidelines, run by University of Cincinnati at 1 site in United States.
Trial summary
Chemotherapy exposure is a serious occupational hazard affecting oncology nurses. Oncology nurses' adherence to chemotherapy handling guidelines is essential to prevent their exposure to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Exposure, Handling Guidelines, Oncology Nurse
- What is being tested?
- The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being at least 18 years old
- able to read and speak English
- working as an oncology nurse for at least 3 months
- handling chemotherapy drugs at work
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45221
Dania Abu-Alhaija, PhD, 513-558-5147, abualhdm@ucmail.uc.edu
About this study
Chemotherapy exposure is a serious occupational hazard affecting oncology nurses. Oncology nurses' adherence to chemotherapy handling guidelines is essential to prevent their exposure to chemotherapy. The goal of this research is to develop, validate, and pilot test an intervention "Workplace program to Improve Safe Handling of hazardous drugs" (WISH), to promote adherence to chemotherapy handling guidelines among oncology nurses. The WISH intervention includes two components: an educational component and debriefing sessions on chemotherapy exposure incidents. First, the research team will use a mixed-methods approach to develop an online educational component on chemotherapy safety, establish the content validity of the educational content based on experts' evaluation, and establish the face validity of the educational content by conducting three qualitative focus group with oncology nurses (n=4-6 nurses per group) or individual interviews. Next, the research team will test the feasibility and acceptability of the intervention using a pilot randomized controlled trial with two groups of oncology nurses, an intervention group (n= 30) and a control group (n=30). We will obtain quantitative and qualitative measures of the intervention feasibility and acceptability. The output is an intervention program targeted to train nurses on safe chemotherapy handling guidelines. Findings will be disseminated through peer-reviewed publications and presentations. The intermediate outcome is the adoption of the intervention program by healthcare institutions to train nurses on chemotherapy handling guidelines. The end outcome is promoting adherence to chemotherapy handling guidelines among oncology nurses.
Read the detailed description
Oncology nurses are at risk for the dangerous health problems of chemotherapy exposure. Chemotherapy exposure is defined as the direct contact with chemotherapy drugs that occurs through skin absorption, hand-to-mouth ingestion, inhalation, and injection with a sharp contaminated object. In order to prevent chemotherapy exposure incidents among nurses, it is important that nurses follow the safe chemotherapy handling guidelines. Unfortunately, the adherence to these guidelines among nurses is lower than the recommended level. The review of the literature reveals the need for an intervention that promotes the adherence to chemotherapy handling guidelines among oncology nurses. The purpose of this study is to develop, validate, and pilot test an intervention to promote adherence to the chemotherapy handling guidelines among oncology nurses.
Specific aim 1: develop and validate an intervention, WISH intervention, to promote greater adherence to safe chemotherapy handling guidelines among oncology nurses. This intervention includes two components 1) an educational component 2) debriefing sessions. In this aim a mixed-method design will be used to: a) Develop an online educational component on chemotherapy exposure and the safe handling guidelines by the study investigators; b) obtain experts evaluation on the content validity of the educational content; c) conduct 3 focus groups with oncology nurses (n=12-18, 4-6 nurses per group) or individual interviews through Zoom to obtain oncology nurses' judgment on the face validity of the educational component (clarity, relevance of the educational material to nurses' responsibilities, usefulness) and to identify other features of the WISH intervention (frequency and duration of the study activities and the type of the debriefing tool). Content analysis methods will be used to analyze the transcripts of the focus groups.
Specific aim 2: test the feasibility and acceptability of the WISH intervention using a pilot randomized controlled trial. This will include two groups of oncology nurses (n=60); an intervention group (n=30), in which nurses will receive the WISH intervention and traditional education on chemotherapy safety by their institution, and a control group (n=30), in which nurses will receive the traditional education on chemotherapy safety by their institution. Sample size was determined by power calculation.
After the informed consent process, participants will take the pretest, then, they will be randomized into control and intervention groups using computer-allocated random numbers. Nurses in the control group will receive the traditional education offered through their institution. Nurses in the intervention group will receive the WISH intervention (online individualized education and debriefing sessions) and the traditional education offered by their institution. Post-tests will be conducted at 6 weeks and 12 weeks after the intervention for both groups using REDCap, a secure web-based application.
Method for sample size calculation:
The target sample size in this study is 60 nurses. This sample size was calculated based on power calculations. With this sample size, this study is powered to detect an effect size at least 0.65 (at power level 80%, α=0.05). This is a feasibility study in which the attrition rate will be determined. Informed by recommendations from previous studies, we will make every effort to retain participants and engage them in all the study activities. Assuming an attrition rate of 10% (54 nurses; 27 in each group), this study will be powered to detect significant differences in the primary outcome (adherence to chemotherapy handling guidelines) with an effect size of at least 0.69 (at power level 80%, α=0.05)
Methods for data analysis:
Feasibility will be measured in terms of the response rate (percent of nurses who responded relative to the number of potential participants who were reached), retention rates (percent of nurse participants who complete the posttests), the time required to reach the target sample size, and the engagement rate (the percent of actual interactions with participants relative to the planned number of interactions). Acceptability will be measured by the Acceptability of Intervention Measure and the adapted measures of ease of use, usefulness, and satisfaction with the study experience, with open-ended comment question. Content analysis method will be used to analyze participants' qualitative feedback on their satisfaction with the study experience.
Descriptive statistics (mean, standard deviation, median, frequencies, percent) will be used to summarize participants' characteristics and other quantitative variables. Sample t-test or Chi square based on the level of measurement will be used to assess if there are significant differences in the demographic, baseline data, and outcome scores between the intervention and control groups. Baseline differences in sample characteristics will be controlled in analysis using ANCOVA.
- Conditions
- Chemotherapy Exposure, Handling Guidelines, Oncology Nurse, Adherence
- Being tested
- The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)Behavioural
The WISH intervention is targeted to promote the adherence to chemotherapy handling guidelines among oncology nurses. The WISH intervention will include two components 1) an individualized online educational component on chemotherapy exposure and the safe handling guidelines with incorporating novel instructional technology tools and 2) debriefing sessions on the incidents of chemotherapy exposure.
| Study group | Role | What they receive |
|---|---|---|
| WISH Intervention Group | Experimental | Participants will receive the WISH intervention (education on chemotherapy exposure risks and safe handling guidelines and debriefing sessions on chemotherapy exposure incidents) in addition to the traditional education on chemotherapy safety typically offered by their institution. Receives: Behavioral: The Workplace program to Improve the Safe Handling of hazardous drugs (WISH) |
| Control Group | No intervention | Participants will not receive intervention in this study. They will receive the traditional education on chemotherapy safety typically offered by their institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' adherence to chemotherapy handling guidelines
This variable will be measured using Hazardous Drug Handling Questionnaire. The scores reflect the percentage of time nurses adhere to chemotherapy handling guidelines and range between 0%-100%. A higher score indicates greater adherence to chemotherapy handling guidelines.
Measured: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Secondary outcomes (2)
Nurses' health beliefs regarding chemotherapy exposure
This variable will be measured using the health beliefs subscales in the Oncology Nurses Health Behaviors Determinants Scale. These subscales are:
- Perceived Threat Subscale: range of scores is 5-25, a higher score indicates greater perceived threat of chemotherapy exposure.
- Perceived Benefit Subscale: range of scores is 3 -15, a higher score indicates greater perceived benefits of adherence to chemotherapy handling guidelines.
- Perceived Barriers Subscale: range of scores is 5-25, a higher score indicates greater perceived barriers of adherence to chemotherapy handling guidelines.
- Perceived Self-Efficacy Subscale: range of scores is 6-30, a higher score indicates greater perceived self-confidence to adhere to chemotherapy handling guidelines.
Measured: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Knowledge on chemotherapy safety
This variable will be measured using Chemotherapy Safety Knowledge questionnaire. This questionnaire will be developed by the study investigators; development is in progress.
Measured: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy ExposureStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into intervention and control groups. Nurses in the intervention group will receive the WISH intervention (online individualized education and debriefing sessions) and the traditional education typically offered by their institution. Nurses in the control group will receive the traditional education typically offered through their institution.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Principal investigator, Dania Abu-Alhaija, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919653
- Sponsor's protocol ID
- 2024-0038
- Other IDs
- K01OH012671
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data related to intervention pilot testing will be preserved in the University of Cincinnati Scholar@UC repository. This will enable sharing the data publicly for purposes of validating and replicating the study results. Participants will be consented on the public sharing of the de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses
- ClinicalTrials.gov ID
- NCT06919653
- Acronym / sponsor ID
- 2024-0038
- Conditions
- Chemotherapy Exposure, Handling Guidelines, Oncology Nurse, Adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 Apr 2025 (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.
Chemotherapy exposure is a serious occupational hazard affecting oncology nurses. Oncology nurses' adherence to chemotherapy handling guidelines is essential to prevent their exposure to chemotherapy. The goal of this research is to develop, validate, and pilot test an intervention "Workplace program to Improve Safe Handling of hazardous drugs" (WISH), to promote adherence to chemotherapy handling guidelines among oncology nurses. The WISH intervention includes two components: an educational component and debriefing sessions on chemotherapy exposure incidents. First, the research team will use a mixed-methods approach to develop an online educational component on chemotherapy safety, establish the content validity of the educational content based on experts' evaluation, and establish the face validity of the educational content by conducting three qualitative focus group with oncology nurses (n=4-6 nurses per group) or individual interviews. Next, the research team will test the feasibility and acceptability of the intervention using a pilot randomized controlled trial with two groups of oncology nurses, an intervention group (n= 30) and a control group (n=30). We will obtain quantitative and qualitative measures of the intervention feasibility and acceptability. The output is an intervention program targeted to train nurses on safe chemotherapy handling guidelines. Findings will be disseminated through peer-reviewed publications and presentations. The intermediate outcome is the adoption of the intervention program by healthcare institutions to train nurses on chemotherapy handling guidelines. The end outcome is promoting adherence to chemotherapy handling guidelines among oncology nurses.
Detailed description
Oncology nurses are at risk for the dangerous health problems of chemotherapy exposure. Chemotherapy exposure is defined as the direct contact with chemotherapy drugs that occurs through skin absorption, hand-to-mouth ingestion, inhalation, and injection with a sharp contaminated object. In order to prevent chemotherapy exposure incidents among nurses, it is important that nurses follow the safe chemotherapy handling guidelines. Unfortunately, the adherence to these guidelines among nurses is lower than the recommended level. The review of the literature reveals the need for an intervention that promotes the adherence to chemotherapy handling guidelines among oncology nurses. The purpose of this study is to develop, validate, and pilot test an intervention to promote adherence to the chemotherapy handling guidelines among oncology nurses.
Specific aim 1: develop and validate an intervention, WISH intervention, to promote greater adherence to safe chemotherapy handling guidelines among oncology nurses. This intervention includes two components 1) an educational component 2) debriefing sessions. In this aim a mixed-method design will be used to: a) Develop an online educational component on chemotherapy exposure and the safe handling guidelines by the study investigators; b) obtain experts evaluation on the content validity of the educational content; c) conduct 3 focus groups with oncology nurses (n=12-18, 4-6 nurses per group) or individual interviews through Zoom to obtain oncology nurses' judgment on the face validity of the educational component (clarity, relevance of the educational material to nurses' responsibilities, usefulness) and to identify other features of the WISH intervention (frequency and duration of the study activities and the type of the debriefing tool). Content analysis methods will be used to analyze the transcripts of the focus groups.
Specific aim 2: test the feasibility and acceptability of the WISH intervention using a pilot randomized controlled trial. This will include two groups of oncology nurses (n=60); an intervention group (n=30), in which nurses will receive the WISH intervention and traditional education on chemotherapy safety by their institution, and a control group (n=30), in which nurses will receive the traditional education on chemotherapy safety by their institution. Sample size was determined by power calculation.
After the informed consent process, participants will take the pretest, then, they will be randomized into control and intervention groups using computer-allocated random numbers. Nurses in the control group will receive the traditional education offered through their institution. Nurses in the intervention group will receive the WISH intervention (online individualized education and debriefing sessions) and the traditional education offered by their institution. Post-tests will be conducted at 6 weeks and 12 weeks after the intervention for both groups using REDCap, a secure web-based application.
Method for sample size calculation:
The target sample size in this study is 60 nurses. This sample size was calculated based on power calculations. With this sample size, this study is powered to detect an effect size at least 0.65 (at power level 80%, α=0.05). This is a feasibility study in which the attrition rate will be determined. Informed by recommendations from previous studies, we will make every effort to retain participants and engage them in all the study activities. Assuming an attrition rate of 10% (54 nurses; 27 in each group), this study will be powered to detect significant differences in the primary outcome (adherence to chemotherapy handling guidelines) with an effect size of at least 0.69 (at power level 80%, α=0.05)
Methods for data analysis:
Feasibility will be measured in terms of the response rate (percent of nurses who responded relative to the number of potential participants who were reached), retention rates (percent of nurse participants who complete the posttests), the time required to reach the target sample size, and the engagement rate (the percent of actual interactions with participants relative to the planned number of interactions). Acceptability will be measured by the Acceptability of Intervention Measure and the adapted measures of ease of use, usefulness, and satisfaction with the study experience, with open-ended comment question. Content analysis method will be used to analyze participants' qualitative feedback on their satisfaction with the study experience.
Descriptive statistics (mean, standard deviation, median, frequencies, percent) will be used to summarize participants' characteristics and other quantitative variables. Sample t-test or Chi square based on the level of measurement will be used to assess if there are significant differences in the demographic, baseline data, and outcome scores between the intervention and control groups. Baseline differences in sample characteristics will be controlled in analysis using ANCOVA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into intervention and control groups. Nurses in the intervention group will receive the WISH intervention (online individualized education and debriefing sessions) and the traditional education typically offered by their institution. Nurses in the control group will receive the traditional education typically offered through their institution.
| Arm | Type | Receives |
|---|---|---|
| WISH Intervention Group | Experimental | Behavioral: The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)Participants will receive the WISH intervention (education on chemotherapy exposure risks and safe handling guidelines and debriefing sessions on chemotherapy exposure incidents) in addition to the traditional education on chemotherapy safety typically offered by their institution. |
| Control Group | No intervention | –Participants will not receive intervention in this study. They will receive the traditional education on chemotherapy safety typically offered by their institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being at least 18 years old
- able to read and speak English
- working as an oncology nurse for at least 3 months
- handling chemotherapy drugs at work
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)The WISH intervention is targeted to promote the adherence to chemotherapy handling guidelines among oncology nurses. The WISH intervention will include two components 1) an individualized online educational component on chemotherapy exposure and the safe handling guidelines with incorporating novel instructional technology tools and 2) debriefing sessions on the incidents of chemotherapy exposure. | Behavioural | WISH Intervention Group |
Primary outcome
Nurses' adherence to chemotherapy handling guidelines
Time frame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
This variable will be measured using Hazardous Drug Handling Questionnaire. The scores reflect the percentage of time nurses adhere to chemotherapy handling guidelines and range between 0%-100%. A higher score indicates greater adherence to chemotherapy handling guidelines.
2 secondary outcomes
Nurses' health beliefs regarding chemotherapy exposure
Time frame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Knowledge on chemotherapy safety
Time frame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. The de-identified data related to intervention pilot testing will be preserved in the University of Cincinnati Scholar@UC repository. This will enable sharing the data publicly for purposes of validating and replicating the study results. Participants will be consented on the public sharing of the de-identified data.
Related trials for Chemotherapy Exposure
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
RecruitingPhase 1/2
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
RecruitingPhase 1/2
A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
Nonmuscle-invasive Bladder Cancer
Not yet recruitingPhase 2
Relacorilant and Nab-Paclitaxel in Recurrent or Metastatic Cervical Cancer
Recurrent or Metastatic Cervical Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Workplace program to Improve the Safe Handling of hazardous drugs (WISH) in people with Chemotherapy Exposure and Handling Guidelines, run by University of Cincinnati 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 1 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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?
Contact Dania Abu-Alhaija, PhD (513-558-5147, abualhdm@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' adherence to chemotherapy handling guidelines (time frame: Baseline, 6 weeks after the intervention, and 12 weeks after the 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 3 Sep 2026.