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Objective To examine the feasibility of soliciting outcomes from adults who received chemotherapy treatment for cancer and describe the patterns and correlates of patient-reported toxicities. Data sources Patient survey data from 29 Michigan ambulatory oncology practices collected in 2017. Study design Secondary analysis of patient survey data. Descriptive statistics were generated at the patient and practice levels. Thematic analysis of open-text comments identified clusters of frequently reported toxicities. Data collection methods Patients completed 11 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Using a 5-point Likert scale, patients rated the frequency of nausea, vomiting, diarrhea, and pain; the severity of nausea, vomiting, constipation, numbness/tingling, and pain; and how much numbness/tingling and pain interfered with usual or daily activities. Patients could also report two toxicities in open-text comments. Finally, patients reported unplanned health care service for toxicity or side effect management. Principal findings Of 3565 eligible patients, 2245 participated (63%) and 457 (20%) rated at least one toxicity as severe/very severe. Across practices, the proportion of patients who reported at least one severe/very severe toxicity ranged from 8% to 50%. Troubling toxicities included pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1653 (74%) reported at least one toxicity in open-text comments; fatigue (n = 182), stomach discomfort (n = 53), and skin/nail changes (n = 41) were most frequently reported. Regarding consequences, 156 patients (7%) reported unplanned health care service use: 41 (26%) visited an emergency department and 32 (21%) were admitted to a hospital. Conclusions Querying patients on chemotherapy treatment experiences and toxicities was feasible. Toxicity rates varied across practices, which informed quality improvement. Toxicity severity and service use incidence exceed previously published trial data, particularly for pain, fatigue, and gastrointestinal issues. Open-text questions enabled exploration with newer treatment regimens.

ObjectivesDespite safe handling guidelines published by several groups, health care worker exposure to hazardous drugs continues to occur due to suboptimal engineering controls and low use of protective equipment. Simple, multi-target and specific analytical methods are needed so that acute exposures to these drugs in the workplace can be assessed rapidly. Our aim was to develop an analytical method for simultaneous detection and quantification of widely used cancer drugs to rule out accidental acute chemotherapy exposures in health care workers.MethodsWe examined the feasibility of alternate high-performance liquid chromatographic-tandem mass spectrometry methods to simultaneously detect eighteen chemotherapy analytes in plasma and urine. The linear concentration ranges tested during assay development were 0.1–50 ng/mL. After development of a multi-analyte assay protocol, plasma samples (n = 743) from a multi-center cluster-randomized clinical trial (n = 12 sites) of an hazardous drug educational intervention were assayed. Confirmatory assays were performed based on the individual acute-spill case-histories.ResultsAn innovative HPLC-multiple reaction monitoring-information dependent acquisition-enhanced production ion (MRM-IDA-EPI) analytical method was developed to simultaneously detect: cytarabine, gemcitabine, dacarbazine, methotrexate, topotecan, mitomycin, pemetrexed, irinotecan, doxorubicin, vincristine, vinblastine, ifosamide, cyclophosphamide, vinorelbine, bendamustine, etoposide, docetaxel, and paclitaxel. The retention times ranged from 4 min to 13 min for the analytical run. The limit of detection (MRM-IDA-EPI) and limit of quantitation (MRM) was 0.25 ng/mL and 0.1 ng/mL, respectively for most analytes. No detectable plasma concentrations were measured at baseline, post-intervention and in cases of documented acute spills. Use of a secondary tandem mass spectrometry approach was able to successfully rule out false positive results.ConclusionsDevelopment of a sensitive high-throughput multi-analyte cancer chemotherapy assay is feasible using an MRM-IDA-EPI method. This method can be used to rapidly rule out systemic exposure to accidental acute chemotherapy spills in health care workers.

Objective The aim of this study was to examine the factors influencing job satisfaction of nurses, physicians, and advanced practice providers in ambulatory oncology settings. Background Job satisfaction is essential to clinician well-being and quality of care. Methods In 2017, clinicians from 29 ambulatory medical oncology practices completed anonymous paper questionnaires that examined job satisfaction, clinician-to-clinician communication, and perceptions of patient safety. Linear regression, adjusted for clustered observations, examined the relationship between job satisfaction, clinician communication, and patient safety perceptions. Results Of 280 respondents (response rate of 68%), 85% reported that they were satisfied or very satisfied with their current position. Patient safety and accuracy of clinician communication were positively and significantly associated with job satisfaction. Conclusions Although most surveyed clinicians were satisfied, 15% were dissatisfied and reported communication and safety concerns. Leadership efforts to strengthen clinician communication actions and develop positive safety cultures are promising strategies to promote clinician well-being and high-quality cancer care.

We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed &lt, 45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored (n = 637) or the targeted (n = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services (p = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm (p &le, 0.001, p &lt, 0.001) and for Black and White/Other YBCS (p &lt, 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).

RESEARCH OBJECTIVE: In the United States, adult patients with cancer receive most chemotherapy treatments in ambulatory settings. Yet outside of clinical trials, these setting rarely collect and report patient‐reported outcomes (PROs), such as treatment‐associated toxicities. As novel cancer treatments expand, we examined the feasibility of collecting PROs from adults with cancer receiving chemotherapy treatment and described the patterns and correlates of patient‐reported toxicities. STUDY DESIGN: We conducted secondary data analysis from a multisite study of ambulatory oncology care quality and safety. On‐site practice champions identified eligible patients who completed an anonymous questionnaire at their appointment check‐in. Patients receiving chemotherapy completed 11 items from the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE), with a recall period of the past seven days. Patients rated each item on a 5‐point scale across three domains: frequency, severity, and interference with daily activities. Patients rated the frequency of nausea, vomiting, diarrhea, and pain (1 = never, 5=almost constantly); the severity of nausea, vomiting, constipation, numbness/tingling, and pain (1 = none, 5 = very severe); and how much numbness/tingling and pain interfered with usual or daily activities (1=not at all, 5=very much). Patients could report two additional side effects in an open‐text section. Descriptive statistics were calculated at both the patient and practice levels to generate practice‐level data summaries. POPULATION STUDIED: Adults with invasive, nonmetastatic cancer and received systemic intravenous chemotherapy treatment at one of 29 medical oncology practices that participated in a statewide quality improvement collaborative. Patients either read English or had a nonclinician proxy available. PRINCIPAL FINDINGS: Of 3,565 eligible patients, 2,245 participated (63%). A total of 1,302 (58%) were female, 389 (17%) were nonwhite, and 257 (11%) were treated in rural settings. A total of 457 patients (20%) rated at least one toxicity as severe/very severe. At the practice level, the proportion of patients per practice who reported at least severe/very severe toxicity ranged from eight to 50 percent. The toxicities rated with the highest severity were pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1,653 (74%) self‐reported at least one additional toxicity in the open‐text section. After thematic analysis, the most frequently reported toxicities in the open‐text section were fatigue (n=182), generalized stomach discomfort (n=53), and skin/nail changes (n=41). Regarding consequences of toxicities experienced since the last chemotherapy treatment, 156 patients (7%) reported unplanned health care service use for toxicity management: 41 (26%) visited an emergency department, and 32 (21%) were admitted to a hospital. CONCLUSIONS: Querying patients directly on their toxicity and related treatment experience was highly feasible. Notable variation in reported toxicities occurred across practices and enabled them to act on their own data. Toxicity severity and related service use exceeded the incidence reported in clinical trials. IMPLICATIONS FOR POLICY OR PRACTICE: Soliciting patient‐reported outcomes from patients outside of clinical trials can inform the clinical community on the patient experience and motivate clinical practice changes. Adults treated for invasive cancer continue to report persistent challenges in managing pain, fatigue, and gastrointestinal issues. Providing patients with open‐text sections enabled the study team to explore toxicities emerging from newer treatment regimens. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Objectives: To evaluate whether a web-based educational intervention improved personal protective equipment (PPE) use among oncology nurses who handle hazardous drugs. Sample & Setting: From 2015 to 2017, the authors partnered with 12 ambulatory oncology settings in the United States to enroll 396 nurses, 257 of whom completed baseline and primary endpoint surveys. Methods & Variables: In a cluster randomized controlled trial, 136 nurses in control settings received a one-hour educational module on PPE use with quarterly reminders, and 121 nurses in treatment settings received the control intervention plus tailored messages to address perceived barriers and quarterly data gathered on hazardous drug spills across all study settings. The primary outcome was nurse-reported PPE use. Results: Control and intervention sites had suboptimal PPE use before and after the intervention. No significant differences were observed in PPE use knowledge or perceived barriers. Participants reported high satisfaction with the study experience. Implications for Nursing: Hazardous drug exposure confers notable health risks to healthcare workers. To improve hazardous drug handling, occupational healthcare workers, health systems, and professional organizations should consider coordinated efforts to implement policy and practice changes.

BACKGROUND: Hazardous drug exposures are a key occupational health hazard to oncology nurses. Sparse data are available regarding the frequency and characteristics of hazardous drug spills to inform clinical practice improvement. OBJECTIVE: To describe nurses’ hazardous drug exposures and use of personal protective equipment during drug spills. METHODS: The Drug Exposure Feedback and Education for Nurses’ Safety study launched in March 2015. When drug spills occurred, consented registered nurses administering chemotherapy in ambulatory infusion settings completed brief questionnaires to describe the spill event, protective equipment worn during the spill, and spill containment efforts. Descriptive statistics were used to summarize equipment use and spill events. FINDINGS: Spills were common, despite the use of closed system transfer devices. Over 24 months, 51 nurses from twelve participating academic infusion centers reported 61 unique spills. Spilled drug volumes ranged from 1 to 250 mLs. Spills commonly involved highly toxic drugs, including paclitaxel (20% of spills), gemcitabine (15%), and anthracyclines (13%). Personal protective equipment use during drug spills is suboptimal; nurses reported wearing disposable gowns (65% of the time), double gloves (52%), single gloves (41%), respirators (28%), and eye shields (26%). Practicing nurses, clinical leaders, and policymakers must address these practice gaps through concerted education, support, and policy changes.

PURPOSE: We know little about how increased technological sophistication of clinical practices affects safety of chemotherapy delivery in the outpatient setting. This study investigated to what degree electronic health records (EHRs), satisfaction with technology, and quality of clinician-to-clinician communication enable a safety culture. METHODS: We measured actions consistent with a safety culture, satisfaction with practice technology, and quality of clinician communication using validated instruments among 297 oncology nurses and prescribers in a statewide collaborative. We constructed an index to reflect practice reliance on EHRs (1 = “all paper” to 5 = “all electronic”). Linear regression models (with robust SEs to account for clustering) examined relationships between independent variables of interest and safety. Models were adjusted for clinician age. RESULTS: The survey response rate was 68% (76% for nurses and 59% for prescribers). The mean (standard deviation) safety score was 5.3 (1.1), with a practice-level range of 4.9 to 5.4. Prescribers reported fewer safety actions than nurses. Higher satisfaction with technology and higher-quality clinician communication were significantly associated with increased safety actions, whereas increased reliance on EHRs was significantly associated with lower safety actions. CONCLUSION: Practices vary in their performance of patient safety actions. Supporting clinicians to integrate technology and strengthen communication are promising intervention targets. The inverse relationship between reliance on EHRs and safety suggests that technology may not facilitate clinicians’ ability to attend to patient safety. Efforts to improve cancer care quality should focus on more seamless integration of EHRs into routine care delivery and emphasize increasing the capacity of all care clinicians to communicate effectively and coordinate efforts when administering high-risk treatments in ambulatory settings.

BACKGROUND Practice-based research is essential to generate the data necessary to understand outcomes in ambulatory oncology care. Although there is an increased interest in studying ambulatory oncology care, given the rising patient volumes and complexity in those settings, little guidance is available on how best to recruit ambulatory oncology practices for research. OBJECTIVE This paper aimed to describe the facilitators and barriers to recruiting ambulatory oncology practices into a large multisite study. METHODS Using a mixed methods design, we sought to recruit 52 ambulatory oncology practices that have participated in a state-wide quality improvement collaborative for the quantitative phase. We used 4 domains of the Consolidated Framework for Implementation Research (CFIR) to describe facilitators and barriers to recruitment. RESULTS We successfully recruited 28 of the 52 collaborative-affiliated practices, collecting survey data from 2223 patients and 297 clinicians. Intervention attributes included multimodal outreach and training activities to assure high fidelity to the data collection protocol. The implementation process was enhanced through interactive training and practice-assigned champions responsible for data collection. External context attributes that facilitated practice recruitment included partnership with a quality improvement collaborative and the inclusion of a staff member from the collaborative in our team. Key opinion leaders within each practice who could identify challenges to participation and propose flexible solutions represented internal context attributes. We also reported lessons learned during the recruitment process, which included navigating diverse approaches to human subjects protection policies and understanding that recruitment could be a negotiated process that took longer than anticipated, among others. CONCLUSIONS Our experience provides other researchers with challenges to anticipate and possible solutions for common issues. Using the CFIR as a guide, we identified numerous recruitment barriers and facilitators and devised strategies to enhance recruitment efforts. In conclusion, researchers and clinicians can partner effectively to design and implement research protocols that ultimately benefit patients who are increasingly seeking care in ambulatory practices.

Multisite research is an important strategy to strengthen the external validity of nursing science (O'Mara, BauerWu, Berry, & Lillington, 2007). In contrast to single-site studies, research projects conducted with multiple sites offer potentially larger, more diverse participant samples and reduce the likelihood of idiosyncratic research findings. Conversely, multisite studies are more complicated to conduct and administer. New complexities also arise when research participants are staff, as opposed to patients or clients.Workplace intervention studies are increasing, due in part to growing awareness that improved worker health and safety have downstream societal benefits (Anger etal., 2015). Specifically, the NationalInstitute for Occupational Safety and Health (NIOSH) has launched the Total Worker Health initiative to respond to this challenge (NIOSH, 2016; Weisfeld, Lustig, & Board of Health Sciences Policy, 2014). Healthy workers are associated with lower turnover, improved economic productivity, and enhanced personal well-being. Due to labor shortages, high acuity, long shifts, and physical demands, NIOSH has identified healthcare workers as a vulnerable labor sector for intervention (NIOSH, 2013). For the past 10 years, our interdisciplinary team has documented the specific concerns of oncology nurses employed in ambulatory oncology settings. These nurses face an unusual occupational threat of hazardous drug exposure given the high patient volume, the explicit emphasis on chemotherapy treatment, and associated continuous risks of exposure.Our team documented that 18% of surveyed ambulatory oncology nurses experienced an unplanned hazardous drug spill in the preceding 6 months (Friese et al., 2014). Hazardous drug exposure is correlated with substantial short- and long-term health effects, such as nausea, vomiting, airway irritation, reproductive problems, and rare cancers (NIOSH, 2004). Despite 30 years of data to support the need for increased vigilance when handling hazardous drugs, surprisingly few nurses wear personal protective equipment as recommended (Connor & McDiarmid, 2006; Polovich & Clark, 2012). Except for the current project, only one published study examined an educational intervention for nurses, conducted in one Malaysian hospital (Keat, Sooaid, Yun, & Sriraman, 2013). Thus, we lack sufficient evidence on how to improve nurses' use of personal protective equipment when handling hazardous drugs.The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a 4-year, multisite cluster randomized controlled trial (Friese, MendelsohnVictor, et al., 2015). The study compares one-time static educational information about hazardous drug exposure prevention to quarterly feedback on study results, coupled with tailored messages designed to reduce barriers to protective equipment use. In planning for the project, we reviewed the sparse literature that describes multisite research project management with registered nurse employees as participants. In the current article, we review successful study implementation strategies and identify important considerations for future research projects that plan to incorporate nurses as participants.ApproachThe DEFENS study is a cluster randomized controlled trial. Nurses who work 16 hr a week or more in ambulatory infusion within 12 large cancer centers in the United States were invited to participate. Full details may be found in the published protocol paper (Friese, Mendelsohn-Victor, et al., 2015) or in the ClinicalTrials.gov registry (National Institutes of Health [NIH], 2016a). Guided by extant models of health behavior and risk reduction, we hypothesized that one-time educational content is insufficient to improve nurses' use of personal protective equipment when handling hazardous drugs (McCullagh, Ronis, & Lusk, 2010). Rather, we compared static educational content (control intervention) to quarterly feedback about data gleaned from our study, coupled with video messages tailored to participants' reported barriers to protective equipment use (experimental intervention). …

Purpose/objectives To examine patterns and organizational correlates of personal protective equipment (PPE) use and hazardous drug spills. Design Cross-sectional mailed survey. Setting Ambulatory practices in California, Georgia, and Michigan. Sample 252 Oncology Nursing Society members who administer hazardous drugs. Methods Bivariate and multivariable regression analyses. Main research variables Outcomes were PPE use and hazardous drug spills. Covariates included nursing workloads, nurses’ practice environments, and barriers to PPE use. Findings Twenty-six percent reported a recent drug spill, and 90% wore only one pair of chemotherapy-tested gloves. Increased PPE use was associated with increased nurse participation in practice affairs, nonprivate ownership, increased nursing workloads, and fewer barriers to PPE use. Spills were associated with significantly less favorable manager leadership and support and higher workloads. Conclusions Drug spills occur often in ambulatory settings. PPE use remains low, and barriers to PPE use persist. Higher workloads are associated with more drug spills. Implications for practice Managers should monitor and correct aberrant workloads and ensure that PPE is available and that staff are trained.

Background Practice-based research is essential to generate the data necessary to understand outcomes in ambulatory oncology care. Although there is an increased interest in studying ambulatory oncology care, given the rising patient volumes and complexity in those settings, little guidance is available on how best to recruit ambulatory oncology practices for research. Objective This paper aimed to describe the facilitators and barriers to recruiting ambulatory oncology practices into a large multisite study. Methods Using a mixed methods design, we sought to recruit 52 ambulatory oncology practices that have participated in a state-wide quality improvement collaborative for the quantitative phase. We used 4 domains of the Consolidated Framework for Implementation Research (CFIR) to describe facilitators and barriers to recruitment. Results We successfully recruited 28 of the 52 collaborative-affiliated practices, collecting survey data from 2223 patients and 297 clinicians. Intervention attributes included multimodal outreach and training activities to assure high fidelity to the data collection protocol. The implementation process was enhanced through interactive training and practice-assigned champions responsible for data collection. External context attributes that facilitated practice recruitment included partnership with a quality improvement collaborative and the inclusion of a staff member from the collaborative in our team. Key opinion leaders within each practice who could identify challenges to participation and propose flexible solutions represented internal context attributes. We also reported lessons learned during the recruitment process, which included navigating diverse approaches to human subjects protection policies and understanding that recruitment could be a negotiated process that took longer than anticipated, among others. Conclusions Our experience provides other researchers with challenges to anticipate and possible solutions for common issues. Using the CFIR as a guide, we identified numerous recruitment barriers and facilitators and devised strategies to enhance recruitment efforts. In conclusion, researchers and clinicians can partner effectively to design and implement research protocols that ultimately benefit patients who are increasingly seeking care in ambulatory practices.

Increasing use of genetic services (counseling/testing) among young breast cancer survivors (YBCS) can help decrease breast cancer incidence and mortality. The study examined use of genetic services between Black and White/Other YBCS, attitudes and knowledge of breast cancer risk factors, and reasons for disparities in using genetic services. We used baseline data from a randomized control trial including a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS. Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups. More White/Other YBCS had received genetic counseling and had genetic testing than Blacks. Although White/Other YBCS resided farther away from board-certified genetic counseling centers, they had fewer barriers to access these services. Black race, high out-of-pocket costs, older age, and more years since diagnosis were negatively associated with use of genetic services. Black YBCS had lower knowledge of breast cancer risk factors. Higher education and genetic counseling were associated with higher genetic knowledge. Racial inequalities of cost-related access to care and education create disparities in genetic services utilization. System-based interventions that reduce socioeconomic disparities and empower YBCS with genetic knowledge, as well as physician referrals, can increase access to genetic services.

Background: Carriers of breast cancer gene (BRCA) mutations are asked to communicate genetic test results to their biological relatives to increase awareness of cancer risk and promote use of genetic services. This process is highly variable from family to family. Interventions that support communication of genetic test results, coping, and offer decision support in families harboring a pathogenic variant may contribute to effective management of hereditary cancer. Objective: The aim of this paper was to describe the development of the Family Gene Toolkit, a Web-based intervention targeting BRCA carriers and untested blood relatives, designed to enhance coping, family communication, and decision making. Methods: We present findings from focus groups regarding intervention acceptability and participant satisfaction and from a pre-post pilot study with random allocation to a wait-listed control group regarding intervention feasibility and usability. Results: The Family Gene Toolkit was developed by a multidisciplinary team as a psycho-educational and skills-building intervention. It includes two live webinar sessions and a follow-up phone call guided by a certified genetic counselor and a master’s prepared oncology nurse. Each live webinar includes two modules (total four modules) presenting information about BRCA mutations, a decision aid for genetic testing, and two skill-building modules for effective coping and family communication. Participants in focus groups (n=11) were highly satisfied with the intervention, reporting it to be useful and describing clearly the important issues. From the 12 dyads recruited in the pre-post pilot study (response rate 12/52, 23%), completion rate was 71% (10/14) for intervention and 40% (4/10) for wait-listed control groups. Conclusions: Acceptability and satisfaction with the Family Gene Toolkit is high. On the basis of the findings from usability and feasibility testing, modifications on timing, delivery mode, and recruitment methods have been implemented. Trial Registration: ClinicalTrials.gov NCT02154633; https://clinicaltrials.gov/ct2/show/NCT02154633 (Archived by WebCite at http://www.webcitation.org/6yYNvLPjv)

This study examined clinical breast exam (CBE) and mammography surveillance in long-term young breast cancer survivors (YBCS) and identified barriers and facilitators to cancer surveillance practices. Data collected with a self-administered survey from a statewide, randomly selected sample of YBCS diagnosed with invasive breast cancer or ductal carcinoma in situ younger than 45 years old, stratified by race (Black vs. White/Other). Multivariate logistic regression models identified predictors of annual CBEs and mammograms. Among 859 YBCS (n = 340 Black; n = 519 White/Other; mean age = 51.0 ± 5.9; diagnosed 11.0 ± 4.0 years ago), the majority (> 85%) reported an annual CBE and a mammogram. Black YBCS in the study were more likely to report lower rates of annual mammography and more barriers accessing care compared to White/Other YBCS. Having a routine source of care, confidence to use healthcare services, perceived expectations from family members and healthcare providers to engage in cancer surveillance, and motivation to comply with these expectations were significant predictors of having annual CBEs and annual mammograms. Cost-related lack of access to care was a significant barrier to annual mammograms. Routine source of post-treatment care facilitated breast cancer surveillance above national average rates. Persistent disparities regarding access to mammography surveillance were identified for Black YBCS, primarily due to lack of access to routine source of care and high out-of-pocket costs. Public health action targeting cancer surveillance in YBCS should ensure routine source of post-treatment care and address cost-related barriers. Clinical Trials Registration Number: NCT01612338.

To identify challenges and solutions to the efficient conduct of a multisite, practice-based randomized controlled trial to improve nurses' adherence to personal protective equipment use in ambulatory oncology settings.The Drug Exposure Feedback and Education for Nurses' Safety (DEFENS) study is a clustered, randomized, controlled trial. Participating sites are randomized to Web-based feedback on hazardous drug exposures in the sites plus tailored messages to address barriers versus a control intervention of a Web-based continuing education video.The study principal investigator, the study coordinator, and two site leaders identified challenges to study implementation and potential solutions, plus potential methods to prevent logistical challenges in future studies.Noteworthy challenges included variation in human subjects' protection policies, grants and contracts budgeting, infrastructure for nursing-led research, and information technology variation. Successful strategies included scheduled Web conferences, site-based study champions, site visits by the principal investigator, and centrally based document preparation. Strategies to improve efficiency in future studies include early and continued engagement with contract personnel in sites, and proposed changes to the common rule concerning human subjects. The DEFENS study successfully recruited 393 nurses across 12 sites. To date, 369 have completed surveys and 174 nurses have viewed educational materials.Multisite studies of nursing personnel are rare and challenging to the existing infrastructure. These barriers can be overcome with strong engagement and planning.Leadership engagement, onsite staff support, and continuous communication can facilitate successful recruitment to a workplace-based randomized, controlled behavioral trial.

Cancer genetic services (counseling/testing) are recommended for women diagnosed with breast cancer younger than 45 years old (young breast cancer survivors—YBCS) and at-risk relatives. We present recruitment of YBCS, identification and recruitment of at-risk relatives, and YBCS willingness to contact their cancer-free, female relatives. A random sample of 3,000 YBCS, stratified by race (Black vs. White/Other), was identified through a population-based cancer registry and recruited in a randomized trial designed to increase use of cancer genetic services. Baseline demographic, clinical, and family characteristics, and variables associated with the Theory of Planned Behavior (TPB) were assessed as predictors of YBCS’ willingness to contact at-risk relatives. The 883 YBCS (33.2% response rate; 40% Black) who returned a survey had 1,875 at-risk relatives and were willing to contact 1,360 (72.5%). From 853 invited at-risk relatives (up to two relatives per YBCS), 442 responded (51.6% response rate). YBCS with larger families, with a previous diagnosis of depression, and motivated to comply with recommendations from family members were likely to contact a greater number of relatives. Black YBCS were more likely to contact younger relatives and those living further than 50 miles compared to White/Other YBCS. It is feasible to recruit diverse families at risk for hereditary cancer from a population-based cancer registry. This recruitment approach can be used as a paradigm for harmonizing processes and increasing internal and external validity of large-scale public health genomic initiatives in the era of precision medicine.

Purpose: Community oncology practices frequently manage chemotherapy-associated toxicities, which may disrupt treatment, impair quality of life, and induce unplanned service use. We sought to understand the patterns and correlates of unplanned health care service use among patients receiving first-cycle chemotherapy at five community-based ambulatory oncology practices. Patients and Methods: A survey study examined the dichotomous outcome of unplanned service use, defined as oncologist visits, emergency department visits, and hospitalizations, resulting from toxicity-related factors. Newly diagnosed patients with breast, lung, head and neck, or colorectal cancer or non-Hodgkin lymphoma were recruited during the first chemotherapy cycle. Before beginning the second cycle of chemotherapy, patients completed a questionnaire that measured unplanned service use and overall distress, plus severity of nausea, vomiting, diarrhea, constipation, mouth sores, intravenous catheter problems, pain, fever and chills, extremity edema, and dyspnea on a 5-point scale (1, did not experience; 5, disabling). Medical record reviews captured chemotherapy doses, comorbid conditions, and supportive care interventions. Mixed-effects logistic regression was used to identify factors associated with unplanned service use, with random effects specified for each clinic. Results: Among 106 patients (white, 98%; female, 74.5%; mean age ± standard deviation, 60 ± 11 years), frequently reported toxicities were pain, nausea, diarrhea, and constipation. Thirty-six patients (34%) reported unplanned service use: 29% reported oncologist visits, 14% reported emergency department visits, and 8% reported hospitalizations. Factors significantly associated with unplanned service use were high patient-reported distress and receipt of colony-stimulating factor. Conclusion: Service use resulting from toxicity-related factors occurs frequently in community oncology settings. Monitoring toxicity patterns and outcomes can inform proactive symptom management approaches to reduce toxicity burden between scheduled visits.

6549Background: We know little about clinicians’ documentation and communication challenges and how these might affect the safety of ambulatory oncology care. The present study investigated variati...

e18721Background: The National Cancer Institute and other key stakeholders endorse soliciting patient-reported outcomes to understand cancer treatment experiences outside of clinical trials. We exa...

Introduction African-American women have higher rates of early-onset breast cancer compared with their Caucasian counterparts; yet, when diagnosed with breast cancer at a young age, they underuse genetic counseling and testing to manage their risk of developing future cancers. Methods Self-reported baseline data were collected between September 2012 and January 2013 and analyzed in 2014 from a subpopulation of 340 African-American young breast cancer survivors (YBCSs) enrolled in an RCT. YBCSs were diagnosed with invasive breast cancer or ductal carcinoma in situ between ages 20 and 45 years and were randomly selected from a statewide cancer registry. Logistic regression examined predictors of using cancer genetics services. Results Overall, 28% of the sample reported having genetic counseling and 21% reported having genetic testing, which were significantly lower ( p ≤0.005) compared with white/other YBCSs participating in the parent study. In a multivariate analysis, income was positively associated with counseling (B=0.254, p ≤0.01) and testing (B=0.297, p ≤0.01), whereas higher education levels (B=−0.328, p ≤0.05) and lack of access to healthcare services owing to cost (B=−1.10, p ≤0.03) were negatively associated with genetic counseling. Lower income and lack of care because of high out-of-pocket costs were commonly reported barriers. Conclusions Despite national recommendations for genetic evaluation among women with early-onset breast cancer, few African-American YBCSs reported undergoing genetic counseling and testing. Most reported that their healthcare provider did not recommend these services. Interventions addressing patient, provider, and structural healthcare system barriers to using genetic counseling and testing in this population are needed.

Background Three decades of research findings have documented the health effects of handling hazardous drugs. Oncology nurses are vulnerable due to frequent administration of antineoplastics, low adherence to equipment use, reported barriers to use, and perceived low risk of health effects. No interventions have been tested in a controlled, multi-site trial to increase nurses’ use of protective equipment when handling hazardous drugs. The Drug Exposure Feedback and Education for Nurses’ Safety (DEFENS) study will compare the efficacy of education (control) versus an audit and feedback intervention (treatment) on nurses’ self-reported use of personal protective equipment when handling hazardous drugs. The treatment intervention will include tailored messages based on nurses’ reported barriers to protective equipment use. Methods/Design The DEFENS Study is a cluster randomized controlled trial. We are enrolling cancer centers and will recruit nurse participants in April 2015. Eligible cancer centers employ at least 20 eligible registered nurses in the chemotherapy infusion setting and have on-site phlebotomy resources. Eligible participants are nurses who work at least 0.40 full-time equivalent hours in the chemotherapy infusion setting and have not received an antineoplastic drug for a health problem in the past year. An encrypted, user-authenticated website will administer surveys and deliver control and treatment interventions. The primary endpoint is the change in score on nurses’ reports of the Revised Hazardous Drug Handling Questionnaire between baseline and approximately 18 months later. A baseline survey is completed after informed consent and is repeated 18 months later. Nurses in all sites who experience a drug spill will also report incidents as they occur; these reports inform the treatment intervention. Plasma will be obtained at baseline, approximately 18 months later (the primary endpoint), and with drug spill occurrences to measure hazardous drugs levels and to inform the treatment intervention. Potential mediators include knowledge of hazardous drug handling and perceived risk of drug exposure. We will examine whether personal factors and organizational factors moderate the intervention effects. Trial registration Clinicaltrials.gov NCT02283164, registered 31 October 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-0674-5) contains supplementary material, which is available to authorized users.

133 Background: Chemotherapy-associated toxicities occur often, yet sparse data are available to correlate toxicities with related service use. Toxicities may disrupt treatment, impair quality of life, and induce unplanned service use. We sought to understand the frequency and correlates of unplanned service use among patients receiving first-cycle chemotherapy at 5 community-based ambulatory oncology practices in southeast Michigan. Methods: A prospective survey examined the dichotomous outcome of toxicity-related unplanned service use. Newly-diagnosed patients were recruited before the first chemotherapy cycle. At the second cycle visit, patients completed a questionnaire that measured severity of nausea, vomiting, diarrhea, constipation, mouth sores, IV catheter problems, pain, fever/chills, extremity edema, and dyspnea on a 5-point scale (1 = did not experience to 5 = disabling). They also rated distress on a 10-point scale (0 = none, 10 = worst). Patients reported unplanned oncologist visits, emergency department visits, and unplanned hospitalizations, all of which were treated as unplanned service use. Mixed-effects logistic regression was used to identify factors associated with unplanned service use, with random effects for each clinic. Results: Among 106 patients (98% white, 74.5% women, mean age 60+11), common diagnoses were breast, lung, and colorectal cancer and non-Hodgkin lymphoma. Frequent toxicities were pain, nausea, diarrhea, and constipation. Thirty-six patients (34%) reported unplanned service use: 29% reported oncologist visits, 14% reported ED visits, and 8% reported hospitalizations. 45% of the total sample and 89% of patients with unplanned service use reported at least one toxicity that was severe or disabling. Factors associated with unplanned service use were high patient-reported distress and receipt of colony-stimulating factor. Conclusions: Toxicity-related service use was common in this community oncology population. Proactive symptom assessment tools may help clinicians manage toxicities between visits. A deeper understanding of toxicity patterns and correlates can inform clinical practice guidelines in community oncology practices.