Hazardous materials online education and study feedback

Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.

Christopher R Friese, PhD

The goal of this research is to evaluate the efficacy of an audit and feedback intervention to improve personal protective equipment (PPE) use by nurses who handle hazardous drugs in the ambulatory oncology setting.

The overall objective of the proposed study is to investigate exposures to hazardous antineoplastic drugs among oncology nurses who handle them. The specific project objective is to evaluate the efficacy of an audit and feedback intervention to improve PPE use by nurses who handle hazardous drugs in the ambulatory oncology setting. This project will pursue three specific aims:

1. Evaluate the efficacy of an audit and feedback intervention to improve recommended use of PPE;
2. Determine whether the intervention effects on PPE use are mediated by knowledge about PPE use and perceived risk of hazardous drug exposure, and;
3. Determine whether the intervention effects on PPE use are moderated by personal (experience, education, certification) and organizational factors (workloads, practice environments, safety organizing).

To achieve these aims, 382 nurses employed in 11 oncology centers will participate in a cluster randomized controlled trial. Sites will be randomized so participants will receive a one-hour web-based educational module on hazardous drug safe handling with quarterly email reminders about the educational content (control) or the web-based educational module plus quarterly feedback on hazardous drug spills and drug levels measured in the study population (treatment). The hypothesis is that nurses in sites who receive the treatment will report significantly higher PPE use compared to nurses in sites assigned to receive the control. Data will also identify organizational factors that can be targeted for future interventions.

Drug Exposure Feedback and Education for Nurses' Safety

Randomized Controlled Trial to Improve Oncology Nurses' Protective Equipment Use

Use of PPE is measured on a 6-point Likert scale (5=always, 4=76-99% of the time, 3=51-75%, 2=26-50%, 1=1-25%, and 0=never). A mean score is calculated for each participant across 5 items: use of chemotherapy gloves, double gloves, single-use disposable gowns, eye protection, and respirators. Higher scores reflect more frequent use of PPE elements.

Knowledge of PPE and perceived risk of hazardous drug exposure are hypothesized to mediate the potential effects of the intervention on PPE use.

1. Knowledge of PPE will be measured using a 10-item chemotherapy exposure knowledge scale. Individual questions about drug exposure are multiple choice. Correct answers are scored as 1 and incorrect answers are scored as 0. The scale range is 0-10, with higher scores reflecting increased knowledge.
2. Perceived risk of drug exposure will be measured using a 3-item subscale from Geer's Occupational Dermal Survey. A 4-point Likert scale (1=strongly disagree, 4=strongly agree) will be used to assess nurses' perceptions of the risks of chemotherapy exposure and potential health effects

Three organizational factors (workloads, practice environments, and safety organizing) are proposed moderators:

1. Workloads will be measured by the number of patients participants had primary responsibility for on their last shift.
2. The practice environment will be measured by calculating the average of a 23-item composite measure across six domains: nurse participation in practice affairs, nursing foundations for quality care, nurse manager support and leadership, collegial nurse-physician relations, staffing and resource adequacy, and medical assistant support. Items are scored on a 5-point Likert scale, where 1=strongly disagree to 5=strongly agree the characteristic is present in the practice.
3. The Safety Organizing Scale (SOS) reflects theoretically derived and empirically observed content domains in high-reliability organizations that avert operational failure. Each item is scored on a 7-point Likert scale (1=not at all, 7=to a very great extent).

Three personal factors (experience, education, and certification) are proposed moderators.

1. nursing experience (years),
2. education (diploma, associate's degree, bachelor's degree, master's degree, post-master's degree)
3. certification (Oncology Nursing Society chemotherapy certification, Oncology Certified Nurse (OCN®), Advanced Oncology Certified Nurse (AOCN®), other certification)

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

University of Michigan

Elizabeth Tone Hosmer Professor of Nursing

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The aim of this observational study is to investigate the association between mid-life changes in cardiorespiratory fitness and the risk of breast cancer incidence and mortality among Swedish women.

The main questions to answer are:

- Are changes in cardiorespiratory fitness associated with the risk of being diagnosed or dying from/with breast cancer later in life?

Participants performed at least two occupational health assessment tests, which consisted of a submaximal ergometer cycle test, measurement of body mass and height to calculate BMI, and a questionnaires on physical and life style habits.

PLAN FOR THE STATISTICAL ANALYSES

This plan has been made before any data analysis has been conducted.

The primary statistical analysis aims to determine if there is any association between changes in estimated cardiorespiratory fitness (both absolute L/min and relative ml/min/kg) and breast cancer incidence and mortality.

Cox proportional hazards models will be analysed with inverse probability treatment weights of time-varying confounders such as BMI, physical activity smoking and alcohol. Time stable confounders will be baseline cardiorespiratory fitness, education, co-morbidities. Risk time will be calculated as the time from last cardiorespiratory fitness test to the diagnosis of breast cancer or the end of study. In addition, restricted cubic splines will be performed.

Secondary analysis will be performed to determine if the association remains after dividing into prespecified groups. The first analysis will be conducted by grouping individuals who decrease, stay stable or increase in cardiorespiratory fitness. The second analysis, we will conduct is an analysis to investigate if age (proxy for menopausal status) modifies the relationships between change in cardiorespiratory fitness and breast cancer incidence or mortality. This will be performed in two analyses by splitting on age 50 and 60, respectively. In the third analysis we will investigate if baseline fitness modifies the association. This will be done with fitness both as a continuous and stratified into tertiles.

Proportional hazard assumption was checked using scaled Schönfelts residuals.

Analysis will include four models and include confounders relevant to the outcomes and research questions. These will be as follows:

Model 1: Baseline cardiorespiratory fitness Model 2: Baseline cardiorespiratory fitness, age, education and date of last health assessment test Model 3: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI Model 4: Baseline cardiorespiratory fitness, age, education and date of last health assessment test, BMI, physical activity, smoking and alcohol intake.

Sensitivity analysis: To address potential reverse causality we will exclude individuals who are diagnosed with breast cancer within two years after the last health assessment.

Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality

The Association Between Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality

The data underlying the findings in this study are currently not publicly available as the original ethical approval application and the informed consent from did not include such direct free access to the data. Data are stored by and can by requested from the HPI Health Profile Institute support@hpi.se.

ICD 10, C50 Malignant neuroplasm of breast

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Drug Exposure Feedback and Education for Nurses' Safety	NCT02283164	Occupational He... Hazardous Mater...	Hazardous mater...	21 Years -	University of Michigan
Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality	NCT05729451	Cancer of Breas... Cardiorespirato... Occupational He...		18 Years -	The Swedish School of Sport and Health Sciences
Change in Cardiorespiratory Fitness and Breast Cancer Incidence and Mortality	NCT05729451	Cancer of Breas... Cardiorespirato... Occupational He...		18 Years -	The Swedish School of Sport and Health Sciences

Spots Global Cancer Trial Database for occupational health