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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the WISH Program for Cancer Treatment?

The research highlights the importance of safe handling practices for hazardous drugs, like those used in cancer treatment, to reduce occupational exposure and potential health risks. Implementing comprehensive safety programs and ensuring proper use of protective equipment can lower the chances of adverse events, suggesting that the WISH Program's focus on improving safe handling could be effective in protecting healthcare workers. ^{1 2 3 4 5}

What safety data exists for the WISH Program for Cancer Treatment?

The WISH Program for Cancer Treatment, also known as The Workplace program to Improve the Safe Handling of hazardous drugs, has been evaluated for safety in healthcare environments. Studies have shown that cytotoxic antineoplastic drugs (used in cancer treatment) pose occupational risks, and safe handling practices are essential to prevent exposure and ensure safety for healthcare workers. ^{5 6 7 8 9}

How is the WISH Program for Cancer Treatment different from other treatments?

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 risk of exposure. Unlike other treatments that target the cancer itself, this program aims to protect those administering the drugs by implementing safety guidelines and interventions. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

[Safety notice for the use of drugs for intravesical instillations and cost analysis]. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Antineoplastic drug handling protection after OSHA guidelines. Comparison by profession, handling activity, and work site. [2019]

3. Thailand pubmed.ncbi.nlm.nih.gov

Safety Management Status among Nurses Handling Anticancer Drugs: Nurse Awareness and Performance Following Safety Regulations. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effects of organizational safety practices and perceived safety climate on PPE usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses. [2018]

5. Croatia pubmed.ncbi.nlm.nih.gov

A new approach to assessing occupational exposure to antineoplastic drugs in hospital environments. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. [2022]

9. Switzerland 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Assessing workplace compliance with handling of antineoplastic agents. [2019]

11. Poland pubmed.ncbi.nlm.nih.gov

[Management of cytostatic drugs by nurses: analysis of preliminary results]. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

Testing an Intervention to Decrease Healthcare Workers' Exposure to Antineoplastic Agents. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

NIOSH safe handling of hazardous drugs guidelines becomes state law. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

NIOSH Safe Handling of Hazardous Drugs Guidelines Becomes State Law. [2019]