WISH Program for Cancer Treatment

Overseen By Dania Abu-Alhaija, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve oncology nurses' safety practices when handling chemotherapy drugs. It focuses on creating and testing a program called WISH (The Workplace program to Improve the Safe Handling of hazardous drugs), which includes online education and debriefing sessions about chemotherapy safety. Nurses with at least three months of experience handling chemotherapy drugs may be suitable for this trial. The goal is to ensure nurses follow safety guidelines to protect themselves from exposure to hazardous drugs. The trial will compare the WISH program's effectiveness with the standard safety training provided by healthcare institutions. As an unphased study, this trial offers nurses the chance to enhance their safety practices and contribute to improving workplace safety standards.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the WISH program is safe for oncology nurses?

Research shows that the WISH Program is designed to help oncology nurses safely handle chemotherapy. It emphasizes teaching and group discussions to reduce the risk of exposure to harmful drugs. Studies have found that programs like this are generally easy to manage. No reports of physical side effects exist because the program doesn't involve taking any medication. Instead, it helps nurses learn how to protect themselves better while working with chemotherapy. The program is currently in a pilot stage, meaning researchers are testing its effectiveness and usefulness for nurses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WISH Program because it focuses on improving how hazardous drugs, like chemotherapy, are safely handled in the workplace. Unlike standard education that typically covers basic chemotherapy safety, the WISH Program offers in-depth education on the risks of chemotherapy exposure and includes debriefing sessions for incidents involving exposure. This approach not only aims to enhance safety practices but also actively involves healthcare workers in understanding and mitigating risks, potentially leading to a safer environment for both staff and patients.

What evidence suggests that the WISH program is effective for promoting adherence to chemotherapy handling guidelines?

Research shows that the WISH Program, available to participants in this trial, helps oncology nurses handle hazardous drugs more safely. It emphasizes increasing the use of personal protective equipment (PPE) to reduce exposure risk. Studies have found that educational programs like this lead to better safety practices and more frequent PPE use. For instance, a web-based training improved PPE use among nurses, demonstrating the effectiveness of structured learning. The WISH Program combines education with follow-up sessions to reinforce these safety habits. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for oncology nurses who handle chemotherapy drugs. It aims to train them in safely managing these hazardous substances to reduce their exposure risk. Nurses currently working with chemotherapy patients are eligible, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have been an oncology nurse for at least 3 months.

I work with chemotherapy drugs.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and validation of the WISH intervention, including educational components and debriefing sessions

Not specified

Pilot Testing

Pilot randomized controlled trial to test feasibility and acceptability of the WISH intervention

12 weeks

Baseline, 6 weeks, and 12 weeks assessments

Follow-up

Participants are monitored for adherence to chemotherapy handling guidelines and other outcomes

12 weeks

Post-tests at 6 weeks and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Workplace program to Improve the Safe Handling of hazardous drugs (WISH)

Trial Overview The WISH program, which includes online education and debriefing sessions on safe handling of chemotherapy drugs, is being tested. The study will compare the effectiveness of this training between a group receiving the intervention and a control group not receiving it.

How Is the Trial Designed?

Group I: WISH Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

Participants will not receive intervention in this study. They will receive the traditional education on chemotherapy safety typically offered by their institution.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

National Institute for Occupational Safety and Health (NIOSH/CDC)

Collaborator

Trials

44

Recruited

50,000+

Published Research Related to This Trial

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

The study evaluated the FDA's selective data collection approach for oncology drugs, finding that it can reduce costs and improve the quality of clinical trial databases.

In cases where additional drug indications are for the same tumor type and usage, the study found a high correlation in adverse reaction data, suggesting that selective data collection is appropriate and effective in these scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals: Frequency of Adverse Reactions Observed During Supplemental Approval Compared With First Approval. Sekine, N., Ohashi, Y., Aruga, A.[2020]

A study involving 236 nurses in Seoul revealed that while awareness of anticancer drug safety regulations was relatively high, actual performance in following these regulations was lower, particularly in drug preparation and disposal.

The research highlighted a positive correlation between nurses' awareness of safety regulations and their performance, suggesting that ongoing education is essential to enhance compliance and safety in handling anticancer drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Management Status among Nurses Handling Anticancer Drugs: Nurse Awareness and Performance Following Safety Regulations. Jeong, KW., Lee, BY., Kwon, MS., et al.[2019]

The number of post-authorization safety and effectiveness studies (PASSs/PAESs) for oncology drugs has significantly increased, from just 1 study between 2006-2010 to 47 studies from 2016-2020, indicating a growing emphasis on real-world evidence for drug safety and effectiveness.

Most of these studies (64.1%) focused on safety/risk assessment, particularly regarding adverse events, while effectiveness studies primarily aimed at measuring overall survival, highlighting the need for more comparative analyses in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. Zhang, X., Chen, L., Bracco, OL., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06919653

Promoting Adherence to Chemotherapy Handling ... The WISH intervention includes two components: an educational component and debriefing sessions on chemotherapy exposure incidents. First, the research team ...

2. withpower.com withpower.com/trial/phase-neoplasms-11-2025-3f726

WISH Program for Cancer Treatment · Info for Participants The WISH Program is unique because it focuses on improving the safe handling of hazardous drugs in the workplace, specifically for healthcare workers who are at ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6425480/

Randomized Controlled Trial of an Intervention to Improve ... To evaluate whether a web-based educational intervention improved personal protective equipment (PPE) use among oncology nurses who handle hazardous drugs.

4. osha.gov osha.gov/hazardous-drugs/controlling-occex

Controlling Occupational Exposure to Hazardous Drugs This informational guidance document outlines OSHA's current recommendations for addressing the health and safety hazards faced by healthcare workers who ...

5. cjon.ons.org cjon.ons.org/publications-research/cjon/21/1/chemotherapy-safe-handling-limiting-nursing-exposure-hazardous-drug

Limiting Nursing Exposure With a Hazardous Drug Control ... Objectives: An evidence-based program for nurses was implemented to improve safe handling practices and reduce exposure to hazardous drugs. Methods: A ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0020748924002207

Knowledge and safe handling practices affecting the ... The data were extracted into the categories of knowledge of risk and safe handling practices, attitude and factors affecting these, and activities that posed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5534163/

Hazardous Drugs: Legislative and Regulatory Efforts to ... Hazardous Drugs: Legislative and Regulatory Efforts to Improve Safe Handling ... Safe handling: implementing hazardous drug precautions.