Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adherence; Oncology Nurse; Chemotherapy Exposure; Handling Guidelines
• Intervention / Treatment: Behavioral: The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dania Abu-Alhaija, PhD; Phone Number: 513-558-5147; Email: abualhdm@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
      • Contact: Dania Abu-Alhaija, PhD; Phone Number: 513-558-5147; Email: abualhdm@ucmail.uc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WISH Intervention Group; 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.	Behavioral: 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.
No Intervention: Control Group; Participants will not receive intervention in this study. They will receive the traditional education on chemotherapy safety typically offered by their institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 weeks after the intervention, and 12 weeks after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 6 weeks after the intervention, and 12 weeks after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study feasibility	Study 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).	Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Intervention acceptability	Acceptability will be measured using Acceptability of Intervention Measure (score range is 4-20) and adapted measures of ease of use (score range is 3-15), usefulness (score range is 4-20), and satisfaction with the study experience (score range is 2-10) with an open-ended comment question. Higher scores indicate more positive acceptability of intervention.	6 weeks after the intervention, and 12 weeks after the intervention

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2024-0038; K01OH012671 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

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