Promoting Adherence to Chemotherapy Handling Guidelines Among Oncology Nurses

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.

• 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]