Clinical trial NCT06919653: Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses
Official title: Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy Exposure
Handling Guidelines
Oncology Nurse
Adherence
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2025-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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 groups with oncology nurses (n=4-6 nurses per group). 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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nurses' adherence to chemotherapy handling guidelines
timeFrame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Secondary outcomes:
measure: Nurses' health beliefs regarding chemotherapy exposure
timeFrame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
measure: Knowledge on chemotherapy safety
timeFrame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
Other outcomes:
measure: Study feasibility
timeFrame: Baseline, 6 weeks after the intervention, and 12 weeks after the intervention
measure: Intervention acceptability
timeFrame: 6 weeks after the intervention, and 12 weeks after the intervention
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References: