The US health care industry is still down tens of thousands of jobs from the end of 2020.

According to a new study by Altarum, a nonprofit research and consulting organization dedicated to improving health outcomes of Medicare and Medicaid beneficiaries, the 11,500 jobs added in March and the 25,000 added in February still left a 44,000 job deficit after a loss of more than 80,000 jobs in January. Compared with the pre-pandemic peak in February 2020, health care employment is down 557,000 jobs, or 3.1%.

Ambulatory settings are seeing a better trend with 15,300 jobs added in March and a net 31,000 jobs in the first quarter of 2021. Physician offices saw a modest increase of 2,900 jobs over the past month and a 1.8% drop in employment, or approximately 54,200 jobs, since the pre-pandemic peak in February 2020, according to the study.

Hospitals had a small drop in employment in March, with 600 jobs lost, and in February, with 1,900 lost jobs, for a total loss of 37,000 jobs at the end of the first quarter of 2021 from the end of 2020. Overall, hospital employment is down approximately 100,000 jobs, or 1.8%, from February 2020, the study results show.

The 44,000 jobs lost in health care during the first quarter of 2021 constitute a loss of one-third of 1% of the 15.9 million health care jobs. 

Turner A, Rhyan C, Miller G, et al. End of first quarter 2021 health employment down 44,000 from end of 2020, Altarum. April 16, 2021. Accessed June 22, 2021. https://altarum.org/sites/default/files/uploaded-publication-files/SHSS-Labor-Brief_Apr_2021.pdf.

Articles

Medical Economics

Small employment increases in March and February didn’t replenish 
the more than 80,000 jobs lost in January.


Number of Health Care Jobs Still Down From End of 2020

Investigators at the Michigan State University (MSU) College of Nursing and the College of Communication Arts and Sciences in East Lansing recently evaluated the effect of Yoga Mind Tools’ 6-week “movement meditation” intervention. Each week, a new meditation was introduced to multidisciplinary clinical teams at a large nonprofit hospice organization.

The 10-minute meditations were designed to relax the body, calm the mind, and encourage mind-body integration, all from the comfort of a chair. They consisted of a series of yoga-based meditation steps that combined breathing, gentle movements, and meditation objects. All sessions engaged interoceptive awareness, with a focus on slow, controlled movement and breathing, aligning movement with breath, and attention to present moment interoceptive bodily sensations and feelings, according to investigators.

“This approach engaged leadership buy-in from the beginning and facilitated shared experiences with the meditations among coworkers throughout the 6-week period for each team,” said Rebecca Lehto, PhD, RN, FAAN, an associate professor at MSU College of Nursing.

There were 76 participants, all of whom completed pre- and postintervention surveys that showed:

two-thirds of those who were present at a staff meeting where the program was introduced went on to do a meditation on their own at least once;

half of hospice professionals (HPs) expressed a desire to continue to have access to the meditations after the 6-week program ended.

The findings confirmed the importance of offering diverse ways to access the meditations. For example, due to COVID-19 work-from-home restrictions when the research was conducted, 75% of HPs did a meditation at home, 29% in a car between patient visits (not while driving), and 23% at the office (these add up to more than 100% because some participants did meditations in more than 1 location). Tablets were used to access the meditations by 58% of HPs who did at least 1 meditation on their own, and smartphones were used by 39%. Computer use was not measured.

The pre- and postintervention surveys assessed burnout using the Stanford Professional Fulfillment Index, which measures professional fulfillment and burnout. The surveys also measured mind-body integration using the Multidimensional Assessment of Interoceptive Awareness scale.

The frequency of meditation was linked to significant improvements in mind-body integration, evidenced by increased attention regulation and self-regulation. In addition, higher interoceptive awareness was significantly related to lower burnout, particularly lower work exhaustion. Interpersonal disengagement became rare and temporary among HPs.

The 10-minute yoga-based meditations—when done regularly—may change how the mind and body respond to stress and help mitigate burnout. Findings showed that the yoga-based meditation intervention was feasible and acceptable and that doing the meditations independently was associated with higher interoceptive awareness. The results also point to a prominent role for interoceptive awareness in reducing the risk for burnout.

The investigators say more still needs to be done. “We need to continue exploring follow-up approaches to integrate the movement meditations into organizational culture and to continue highlighting the importance of thinking beyond a one-time intervention to support health care provider well-being and combat burnout,” said Carrie Heeter, PhD, a media and information professor at MSU and director of Yoga Mind Tools. 

Partner Perspectives

A program evaluated at Michigan State University has shown that meditation helps combat burnout and promote well-being among health care workers, particularly in hospice settings. 


Hospice Professionals Use Mind, Body, and Movement Meditation to Reduce Stress

The role of the advanced practice registered nurse (APRN) has evolved over the past 4 decades, originating in Canada and the United States.

The International Council of Nurses helped to define and guide the structure of the role of the advanced practice nurse throughout the rest of the world. Advanced practice roles such as APRNs are formally defined through educational preparation, scope of practice, and regulatory mechanisms.

 Advanced practice providers contribute to the overall experience and delivery of the highest-quality care through every stage of the patient’s health care journey.

It is no secret that APRNs are instrumental in the care of patients with cancer and the advancement of oncology practice. They support the treatment plan and manage the patient’s disease process. Moreover, APRNs’ continual education fosters an ever-learning environment and sustains professional development. APRNs utilize evidence-based practices and research to facilitate the best patient outcomes and service.

“The role of the advanced practice provider in radiation oncology encompasses a collaboration of care between the patient, family, and physician,” said Lori VanHorn, ANP-BC, APNP, MSN, RN, a nurse practitioner at Cancer Treatment Centers of America, Chicago, in Illinois. “This care continuum is benefited by the APRN who provides a detailed assessment, symptom management, and supportive attention though specialty expertise. The continuity of care provided to patient and family further allows for a positive treatment experience while imparting a dedicated team environment.”

Studies have demonstrated that patients who receive care from APRNs are more satisfied with their experience.

 Furthermore, as the number of cancer survivors continues to grow, advanced practice providers will continue to evolve as an integral component of the oncology practice, ensuring access to quality care.

As long as patients continue to receive cancer diagnoses, it is imperative to ensure that there are APRNs available to support optimal treatment plans.

“It is of the upmost importance to continue to have APRNs dedicated to the treatment and care of the [patients with cancer],” said Yolanda Coleman, PhD, MS, RN, FACHE, NEA-BC, chief nursing officer at Cancer Treatment Centers of America, Chicago. “We will continue to need the expertise and advocacy of the APRNs who commit their service to our patients, families, and communities.”

1965 – University of Colorado develops first nurse practitioner (NP) program.

1975 – More than 65 NP programs are available within the United States

1974 – The Council of Primary Care Nurse Practitioners is created by the American Nurses Association (ANA). The council helps to legitimatize the position.

1983 – The US has between 22,000 and 24,000 NPs.

1985 – American Academy of Nurse Practitioners (AANP) is created.

1992 – AANP collaborates with international nursing associations, including the Royal College of Nursing in the United Kingdom, to establish the role across the globe.

2005 – Oncology Nursing Certificate Corporation offers 2 role-specific advanced certification examinations: Advanced OncologyCertified Nurse Practitioner and Advanced Oncology Certified Clinical Nurse Specialist.

2017 – More than 80% of oncology practices employ advanced practice providers (APPs).

2018 – There are 5350 oncology APPs in the US.

2021 – There are more than 325,000 NPs in the US.

Schneider F, Kempfer SS, Backes VMS. Training of advanced practice nurses in oncology for the best care: a systematic review. 

. 2021;55:e03700. doi:10.1590/S1980-220X2019043403700

Definition and characteristics of the role. NP/APN Network. Accessed July 19, 2021. https://international.aanp.org/practice/apnroles

Swan M, Ferguson S, Change A, Larson E, Smaldone A. Quality of primary care by advanced practice nurses: a systematic review. 

. 2015;27(5):396-404. doi:10.1093/intqhc/mzv054

Bruinooge SS, Pickard TA, Vogel W, Amy Hanley, Caroline Schenkel, Elizabeth Garrett-Mayer, Eric Tetzlaff, Margaret Rosenzweig, Heather Hylton, Shannon N. Westin, Noël Smith, Conor Lynch, Michael P. Kosty, and Stephanie F. Williamset al. U

nderstanding the role of advanced practice providers in oncology in the United States

2018;45(6):786-800. doi:10.1188/18.ONF.786-800

Coombs LA, Hunt L, Cataldo J. A scoping review of the nurse practitioner workforce in oncology. 

2016;5(8):1908-1916. doi:10.1002/cam4.769

History of ONCC. Oncology Nursing Certification Corporation. Accessed July 19, 2021. https://www.oncc.org/history

First large-scale survey of advanced practice providers in oncology shows growing role for nurse practitioners and physician assistants. The ASCO Post. August 23, 2018. Accessed July 19, 2021. https://ascopost.com/News/59197

APP Page

The APRN position has an important, albeit recent, history. 


The Evolving Role of the APRN in Oncology Care

Oncology nurses embody the meaning of excellent supportive care. And in this issue, we celebrate 2 oncology nurses who have exemplified excellence not only in their daily practices but especially throughout the COVID-19 pandemic. In our Oncology Nursing Champion section, we recognize the accomplishments of Lisa Cusaac, MSN, RN, OCN, of MedStar Georgetown University Hospital, and Kathleen Lutz, NP, NP-BC WH, of NYU Langone Health.

Welcoming work environments foster nurses who work to the best of their ability. Our cover story on oncology nurse bullying and violence in the workplace addresses questions regarding nurse safety and offers insights into how to maximize safety and security to ensure the happiness and productivity of the oncology nurses who work there.

Also in this issue, we dive into how playing music can positively affect a patient’s experience during painful procedures and we explore how meditation can help combat burnout for health care providers working in hospice settings. We urge readers to be on the lookout for altered mental states—their own and that of their friends, family, and colleagues—following the COVID-19 pandemic.

Our continuing education (CE) section covers updates presented at the annual American Society of Clinical Oncology meeting. Head over to OncNursingNews.com after reading the content and take the online quiz to earn CE credit. Our goal at 

® is to keep nurses up-to-date not only on the latest clinical advancements but also on the evolving world of health care in general. Our medical economics section takes a hard look at how the COVID-19 pandemic has hit the health care industry. We also detail recent notable FDA approvals in our Medical World News® section.

Burnout and mental distress are prevalent in health care settings and can bring a load of heavy consequences. If you or your coworkers have experienced stress and fatigue, particularly in the wake of the COVID-19 pandemic, 

Read on for information to help identify signs, combat distress, and create healthy work environments to protect yourself and your team.

From the Chairman

Oncology nurses embody the meaning of excellent supportive care. 

Oncology Nurses Are  Champions Every Day

The World Health Organization defines mental health as “a state of well-being in which the individual realizes his or her own abilities, can cope with normal life stressors, can work productively and fruitfully, and can make a contribution to his or her community.”

 Nurses are aware that the risk of psychological effects from the COVID-19 pandemic is significant and that patients, families, and colleagues may respond with stress, anxiety, depression, insomnia, or, in worst cases, suicidal thoughts. Psychological support services for patients and colleagues are critically needed and should be a vital component in postpandemic planning.

The pandemic changed the daily lives of Americans. It has taken a toll on individuals’ mental health and created new barriers for those seeking mental health care. The world has confronted many new issues in the past 18 months, such as fear of contracting the coronavirus, fear of job loss, lack of child care options, and the devastating loss of loved ones due to COVID-19. All have had a crippling effect on the nation’s mental health.

As the world slowly starts to recover, a sense of isolation remains. Anxiety, depression, and insomnia linger, and loneliness, drug and alcohol use, and domestic violence are on the rise.

 Health care providers believe the pandemic may have an enormous impact on the mental health of the global population, leading to “an increase in cases of depression, suicide, and self-harm.”

Such predictions are reflected in an analysis completed by the Kaiser Family Foundation from March 2021. In total, 46% of mothers surveyed stated that COVID-19 affected their mental health.

School closures and lack of child care greatly affected parents with children younger than 18, many of whom were either working from home or leaving their children to work in the office during the pandemic.

The Kaiser Family Foundation COVID-19 data reveal disparity issues in health care. Minority groups, women, low-income communities, and the elderly often lack access to crucial health care services. According to the CDC,

 unmet mental health needs also increased significantly from 9.2% to 11.7%. The largest increases in unmet mental health needs were among adults aged 18 to 29 years (7.2 percentage points) and those with less than a high school education (4.3 percentage points).

Because oncology nurses are aware of vulnerable populations, it is important to carefully assess patients for depression, anxiety, and possible suicidal thoughts. Ask yourself: Do our patients have money for food, medications, parking, and gas? Are they working or has their compromised immunity kept them home? Do they speak of isolation, sadness, or signs of depression? Do they need referrals to a mental health provider? Do they need help with medication? Can cancer organizations help them with grants for gas and food?

As we take inventory of our patients, we also should look at coworkers, family, and ourselves to see how life is for everyone. The pandemic has affected us all and the world remains in crisis. As oncology nurses, we are poised to help.

1. Mental health: strengthening our response. World Health Organization. Updated March 30, 2021. Accessed July 9, 2021. https://www.who.int/news-room/fact-sheets/detail/mental-health-strengthening-our-response

2. Abramson A. How COVID-19 may increase domestic violence and child abuse. American Psychological Association. April 8, 2020. Accessed July 9, 2021. https://www.apa.org/topics/covid-19/domestic-violence-child-abuse

3. LiW, Yang Y, Liu ZH, et al. Progression of mental health services during the COVID-19 outbreak in China. 

. 2020;16(10):1732-1738. doi: 10.7150/ijbs.45120

4. Kearney A, Hamel L, Brodie M. Mental health impact of the COVID-19 pandemic: an update. Kaiser Family Foundation. April 14, 2021. Accessed July 9, 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/mental-health-impact-of-the-covid-19-pandemic/

5. Reduced access to care. CDC. Updated June 30, 2021. Accessed July 9, 2021. https://www.cdc.gov/nchs/covid19/pulse/reduced-access-to-care.htm

Nurse's Notes

 Psychological support services for patients and colleagues are critically needed and should be a vital component in postpandemic planning. 

Stay Alert for Mental Health Issues  Exacerbated by COVID-19 Pandemic 

August 22, 2022 This activity is provided free of charge.

This CE article is designed to serve as an update on cancer detection and prevention and to facilitate clinical awareness of current and new research regarding state-of-the-art care for those with or at risk for cancer.

Advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients may participate in this CE activity.

Upon completion, participants should be able to:

Describe new preventive options and treatments for patients with cancer

Identify options for individualizing the treatment for patients with cancer

Assess new evidence to facilitate survivorship and supportive care for patients with cancer

ACCREDITATION/CREDIT DESIGNATION STATEMENT

Physicians' Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669 for 0.5 Contact Hour.

It is the policy of Physicians' Education Resource®, LLC (PER®) to ensure the fair balance, independence, objectivity, and scientific objectivity in all of our CE activities. Everyone who is in a position to control the content of an educational activity is required to disclose all relevant financial relationships with any commercial interest as part of the activity planning process. PER® has implemented mechanisms to identify and resolve all conflicts of interest prior to release of this activity.

The planners and authors of this CE activity have disclosed no relevant financial relationships with any commercial interests pertaining to this activity.

1. Read the articles in this section in their entirety.

3. Complete and submit the CE posttest and activity evaluation.

This CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CE activity is for continuing medical nursing purposes only and is not meant to substitute for the independent medical judgment of a nurse or other health care provider relative to diagnostic, treatment, or management options for a specific patient's medical condition.

The opinions expressed in the content are solely those of the individual authors and do not reflect those of PER®

Colon: Real-World Analysis on Second-Line Cetuximab in mCRC Reveals Factors Linked With Longer Time on Treatment, OS

Liver: Regorafenib/Pembrolizumab Combination Yields Encouraging Results in Advanced HCC

Real-World Analysis on Second-Line Cetuximab in mCRC Reveals Factors Linked With Longer Time on Treatment, OS

In patients with metastatic colorectal cancer (mCRC) treated with cetuximab (Erbitux) as a second-line therapy after irinotecan or oxaliplatin-based regimens have failed, 

 mutational status and geographical region were associated with time on treatment (TOT), while body mass index (BMI) and age were linked with overall survival (OS), according to data from a real-world retrospective analysis.

Results, which were presented during the virtual 

2021 American Society of Clinical Oncology Annual Meeting

, indicated that the median TOT in patients who received second-line cetuximab was 3.94 months (median interquartile range [mIQR], 3.51-4.40), while the median OS was 14.36 months (mIQR, 13.01-15.70).1

Moreover, receiving second-line treatment with cetuximab plus FOLFIRI (Leucovorin, fluorouracil, irinotecan) (median TOT = 4.43 months; mIQR, 3.71-5.36), having 

 wild-type status, and receiving second-line cetuximab following frontline capecitabine plus oxaliplatin (CapeOX), were all associated with a longer median TOT. Furthermore, residing in the South region vs the Midwest of the United States was linked with a shorter median TOT.

Having a higher BMI was associated with a longer median OS (obese vs underweight HR, 0.46; 95% CI, 0.32-0.66), while receiving treatment with second-line FOLFOX (cetuximab plus 5-fluorouracil, leucovorin, and oxaliplatin) was linked with a shorter median OS (10.97 months; mIQR, 5.55-14.06). Additionally, age greater than 65 years was also linked with a shorter median OS (≥ 65 years vs < 65 years; HR, 1.24; 95% CI 1.05-1.46).

Anti-epidermal growth factor receptor drugs are being increasingly utilized in later lines of therapy in patients with mCRC, but the real-world TOT and OS of patients who receive cetuximab in the second-line setting has not been examined. As such, investigators set out to examine characteristics linked with TOT and OS using retrospective, observational data.

Between January 2013 and August 2020, 1011 patients were selected from the nationwide Flatiron electronic health record database. Patients were included in the analysis if they had a mCRC diagnosis, received second-line treatment with a cetuximab-based regimen, and had progressed on oxaliplatin/irinotecan-based regimens in the front line.

Investigators defined TOT as the time from start of cetuximab in the second line to the last date of evidence of administration. End of treatment was defined if patients progressed to a third line of therapy or if they had a death record. Additionally, OS was calculated from index date to the date of death or censored to the last visit date available.

Among the 1011 patients included in the analysis, more than half were younger than 65 years (58%) and male (60%). Additionally, patients had a median BMI of 26.6 kg/m², had previously received FOLFOX regimens in the first-line setting (61%), and received treatment in the community setting (96%). The most frequently used second-line treatment regimens were cetuximab plus FOLFIRI (46%) and cetuximab plus irinotecan (29%).

Gathirua-Mwangi W, Yang T, Khan T, et al. Real-world time on treatment and overall survival in patients with metastatic colorectal cancer receiving cetuximab in second line after failing irinotecan or oxaliplatin-based regimens. 

. 2021;39(suppl 15):e15568. doi:10.1200/JCO.2021.39.15_suppl.e15568

Regorafenib/Pembrolizumab Combination Yields Encouraging Results in Advanced HCC

The combination of regorafenib plus pembrolizumab in the first-line setting for patients with advanced hepatocellular carcinoma showed encouraging antitumor activity with a disease control rate of 88-91%, and did not display any new safety signals.

The combination of regorafenib (Stivarga) plus pembrolizumab (Keytruda) in the first-line setting for patients with advanced hepatocellular carcinoma (HCC) showed encouraging antitumor activity with a disease control rate (DCR) of 88-91%, and did not display any new safety signals, according to updated data presented during the virtual 2021 American Society of Clinical Oncology Annual Meeting.1

Researchers looked at combining the 2 individual therapies, previously approved as monotherapies for patients with advanced HCC who progressed on sorafenib (Nexavar), in a phase 1b study (NCT03347292) that evaluated 57 patients with advanced HCC who had no prior systemic therapy. Treatment in the first cohort (n = 35) consisted of 120 mg of regorafenib daily on a 3 week on, and 1 week off schedule, and 200 mg of pembrolizumab given intravenously every 3 weeks. Treatment was planned to either escalate to 160 mg or lower to 80 mg of regorafenib, but only an exploratory cohort (n = 22) received 80 mg due to a high volume of dose modification in the 120 mg cohort. At the data cut off, 50% of the patients in the 80-mg cohort remained on treatment.

Response rates among both cohorts were similar; 31% of patients had an objective response rate (ORR) in the 120 mg cohort and patients in the 80 mg cohort had an ORR of 32%. Moreover, the 80 mg cohort had a median follow up of 10 months and displayed a median progression-free survival (PFS) of 6.9 months (95% CI, 3.8, not estimated [NE]) and a median time-to-progression (TTP) of 6.9 months (95% CI 2.9, NE), with insufficient follow up for overall survival (OS) data. In the 120 mg cohort, after a median follow up of 13.9 months, median OS, PFS, and TTP, was 26.5 months (95% CI 11.4, NE), 7.5 months (95% CI 4.1, 11.7), and 8.1 months (95% CI 4.1, 23.9), respectively.

Out of 32 evaluable patients in the 120-mg cohort 31% of patients had a partial response and 56% had stable disease with a DCR of 88%. Twenty-two patients in the 80-mg cohort had a higher DCR at 91% with 32% showing partial responses and 59% had stable disease.

“Overall, 57 patients were treated,” said Anthony B. El-Khoueiry, MD, from the Keck School of Medicine, University of Southern California, and lead investigator of the study, at a virtual presentation of the data at the 2021 American Society of Clinical Oncology meeting.2 “At baseline, most patients had an ECOG Performance Status of 0. All patients had Child-Pugh A and approximately 80% were BCLC [Barcelona Clinic Liver Cancer] stage C. And two-thirds had extrahepatic disease and/or microvascular invasion.”

In comparing the 2 cohorts, the 80-mg cohort had a more favorable safety profile and lower rates of dose reductions and treatment interruptions, according to El-Khoueiry. In the 120-mg cohort, two-thirds of patients had a treatment-emergent adverse event (TEAE) that led to interruption of treatment or dose reduction. Grade 3 or 4 TEAE occurred in 86% of patients in the 120-mg cohort compared with 55% in the 80-mg cohort. The most common grade 1-2 TEAEs in both cohorts included fatigue, diarrhea, increased bilirubin, and increased lipase. The majority of grade 3 to 5 TEAE were linked with regorafenib in the 120-mg cohort at 74% of TEAEs compared with 51% in pembrolizumab, however, in the 80-mg cohort 41% of grade 3 to 5 TEAEs were related to regorafenib compared with 23% in pembrolizumab.

“There was no apparent association between regorafenib exposure and objective tumor response, and there was substantial overlap in individual exposures,” explained El-Khoueiry when talking about an additional biomarker analyses researchers completed. “The biomarker analyses were limited by small sample size and lack of power to compare the 2 dose levels. Nonetheless, we did see a decrease in the ratio of CD4-positive to CD8-positive T cells from baseline, which was more apparent in the 120-mg cohort.”

El-Khoueiry A, Kim R, H W, et al. Updated results of a phase 1b study of regorafenib (REG) 80 mg/day or 120 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC). 

. 2021;39(suppl 15; abstr 4078). doi: 10.1200/JCO.2021.39.15_suppl.4078

El-Khoueiry A, Kim R, H W, et al. Updated results of a phase 1b study of regorafenib (REG) 80 mg/day or 120 mg/day plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC). Presented at: 2021 American Society of Clinical Oncology Annual Meeting; June 4-8, 2021; Virtual. Abstract 4078.

Clinical Insights

CE lesson worth 0.5 contact hour that is intended to advanced practice nurses, registered nurses, and other healthcare professionals who care for patients with cancer.

Continuing Education: August 2021

Although chimeric antigen receptor (CAR) T-cell therapies like ciltacabtagene autoleucel (cilta-cel; JNJ-68284528) can lead to neurologic adverse events (AEs) in patients with relapsed/refractory multiple myeloma, the toxicities can be managed without long-term effects as long as they are treated promptly, according to findings from CARTITUDE-2 presented at the European Hematology Association 2021 Virtual Congress.

“To date, more than 100 patients across the CARTITUDE study program have been dosed with cilta-cel. When implemented, patient [treatment] strategies have reduced the incidence of neurotoxicity, including movement and neurocognitive events,” said Hermann Einsele, MD, FRCP, professor and chair of the Department of Internal Medicine at the Julius Maximilians University of Würzburg in Germany, during a presentation of the study findings.

The open-label, phase 2, multicohort CARTITUDE-2 (NCT04133636) trial evaluated the efficacy and safety of cilta-cel in patients with multiple myeloma. For the purpose of studying adverse vents (AEs), the investigators analyzed cohort A, which involved patients with multiple myeloma who progressed after 1 to 3 lines of therapy, including a proteasome inhibitor or an immunomodulatory drug.

Eligible patients were adults with measurable disease and ECOG performance status of 0 or 1. Their disease had to be refractory to lenalidomide (Revlimid) and not previously treated with another BCMA-targeted drug.

Patients received cilta-cel (0.75 × 106 [range: 0.5-1.0 × 106] CAR+ viable T cells/kg) as a single infusion 5 to 7 days after the initiation of lymphodepletion (cyclophosphamide 300 mg/m2 + fludarabine 30 mg/m2 daily for 3 days).

“Patient [treatment] strategies included more effective bridging therapy to reduce baseline tumor burden, early aggressive treatment of [cytokine release syndrome] and [immune effector cell-associated neurotoxicity], as well as handwriting assessment for early detection of symptoms of neurotoxicity,” Einsele said. “These strategies have been successfully implemented across the CARTITUDE program.”

At a median follow-up of 5.8 months (range, 2.5-9.8), 20 patients in cohort A received cilta-cel, of which 4 (20%) experienced at least 1 neurotoxicity. Three patients had grade 1/2 immune effector cell-associated neurotoxicity (ICANS) along with cytokine release syndrome. The median time to symptom onset was 8 days (range, 7-11), and, on average, symptoms lasted 2 days. Two patients received supportive measure for their ICANS, including levetiracetam and steroids.

One patient experienced isolated grade 2 facial paralysis on day 29. The patient recovered 51 days later after being treated with dexamethasone for 28 days. Overall, there were no movement or neurocognitive disorders reported within cohort A.

“Importantly, none of the patients in the cohort A of the CARTITUDE study experienced other neurotoxicities that were seen in CARTITUDE-1 (NCT03548207),” Einsele said.

Einsele H, Parekh S, Madduri D, et al. Incidence, mitigation, and management of neurologic adverse events in the phase 2 CARTITUDE-2 study of ciltacabtagene autoleucel in patients with multiple myeloma. Presented at: 2021 European Hematology Association Congress. June 9-17, 2021; virtual. Abstract EP1003.

Feature Story

In the cohort of patients with multiple myeloma, there were no grade 3 or higher neurotoxicities. 


Neurotoxicity With Cilta-cel: Early Intervention Can Improve Outcomes in R/R Myeloma

Three years ago, LaToya Lewis, EdD-CI, MSN, RN, and her colleagues embarked on a study to evaluate horizontal violence and bullying among nurses who work in oncology inpatient units and outpatient services at an academic medical center in South Florida.

Although bullying and incivility in nursing are not new issues, they are a pervasive problem. A 2017 survey found that 45% of nurses had been verbally harassed or bullied by other nurses, and 41% had been bullied by managers or administrators. And although previous studies have examined how bullying affects all nurse specialties, Lewis, an assistant professor of clinical at the University of Miami School of Nursing and Health Studies in Florida, and her colleagues specifically looked at how bullying affected oncology nurses.

“Through our survey, we found that bullying was more prevalent in the outpatient oncology clinic, although nurses who worked in both inpatient and outpatient settings experienced conflict,” Lewis said.

Many of the nurses surveyed experienced horizontal or lateral violence, which Lewis described as nonphysical, hostile, aggressive, or harmful behavior toward a coworker.

“Horizontal violence is characterized by emotional, verbal, and defiant behaviors such as snide remarks, public humiliation, talking down to a colleague, mocking, harassment, and intimidation,” Lewis said. “Physical violence can involve pushing, grabbing, or invading a coworker’s physical space.”

All forms of workplace bullying can take their toll on nurses and lead to reduced self-esteem, anxiety, depression, and even physical symptoms such as insomnia and gastrointestinal issues.

“Many nurses reported feeling hesitant to report the bullying because they thought it would only make the situation worse,” Lewis explained. “The effects of horizontal violence and bullying not only negatively impact a nurse’s professional quality of life, they also affect nursing retention and employee and patient satisfaction.”

When the survey was completed, Lewis and her colleagues reported the findings to hospital administrators, who were surprised by the results.

“The administration believed they had a zero tolerance for workplace bullying, and they weren’t aware of some of the incidents,” Lewis said. “Many nurses suffered in silence rather than voice their concerns because they had seen others report horizontal violence, only to have the problems persist.”

As a result, the medical center began incorporating education about appropriate professional behaviors that are consistent with the hospital’s code of conduct into orientations for new hires, Lewis said. Administrators also worked to engage midlevel nurses and other oncology staff to advocate for a culture of kindness and civility.

“In addition to establishing programs that promote awareness and discuss how to address workplace bullying, the medical center also put a renewed emphasis on positive behavior and the contributions of their nursing staff through programs such as the DAISY Foundation awards,” Lewis said. “Nursing leaders can create a positive work environment that serves to thwart workplace bullying.”

Judith Vessey, PhD, MBA, FAAN, the Lelia Holden Carroll Professor in Nursing at Boston College’s Connell School of Nursing in Massachusetts, also has conducted research on horizontal violence and bullying among nurses.

In her study “Bullying of Staff Registered Nurses in the Workplace,”

 which was published in 2009, Vessey and her colleagues found that perpetrators of workplace bullying included senior nurses, charge nurses,
nurse managers, and physicians who publicly humiliated, isolated, excluded, or excessively criticized staff nurses. According to Vessey, stress levels were reported as moderate to severe among nurses. The lack of an
available workplace solution meant that support was found primarily among family, colleagues, and friends.

“It’s important to begin by looking at what’s happening at the unit level, how good is the leadership, and [whether] nurses see themselves as part of a team and have a sense of psychological safety,” Vessey said. “Unfortunately, some nurses work in an unhealthy environment where they don’t feel safe speaking up.”

Vessey explained that psychological safety is when an employee can speak up without risking embarrassment, humiliation, or punishment.

“Psychological safety creates a climate where nurses can do their best work,” Vessey said. “Without psychological safety, a nurse who is being bullied won’t come forward and the bad behavior will continue.”

Over time, Vessey says workplace incivility and bullying can lead to low employee morale, increased absenteeism, and high turnover.

“It’s important to create an environment where nurses want to work and incivility and horizontal violence are not tolerated,” Vessey says. “Unit-based leaders may be aware of bullying but unsure how to address it. These leaders can start by creating opportunities for dialogue between staff members and encouraging staff feedback.”

In addition to being patient advocates, nurses also need to master being advocates for their colleagues and for themselves. Conflict resolution training can teach nurses the skills they need to diffuse workplace bullying scenarios, whereas nurse mentorship programs can foster teamwork, combat bullying, and increase retention among nurses who are just beginning their careers in oncology. 

When Patients and Families Become Violent

In addition to cases of horizontal violence among nurses, cases of workplace violence involving patients and family members are also on the rise. In November 2020, National Nurses United surveyed 15,000 registered nurses around the country and found that 20% reported an increase in workplace violence. Among the reasons for the increase, the survey results showed, were decreased staffing levels, visitor restrictions, and mandatory masking.

Typically, nurses are not taught how to handle violence while in nursing school, but, fortunately, there are many free resources available to help nurses learn how to safeguard themselves.

The Crisis Prevention Institute offers programs in nonviolent crisis intervention, verbal intervention, dementia care, conflict prevention techniques, and more. Available online courses teach important deescalation techniques and risk assessment.

The Occupational Safety and Health Administration (OSHA) has published a guidebook for nurses and other health professionals who want to learn strategies for preventing workplace violence.

National Nurses United is offering an online class: “Violence on the Job: Prevention and Advocacy for Nurses.” The hourlong class is free during the pandemic. The 1 continuing-education unit course discusses effective workplace violence prevention measures and how nurses can advocate for violence prevention at their workplace.

The Centers for Disease Control and Prevention offers “Workplace Violence Prevention for Nurses,” a free interactive online course that illustrates how to recognize warning signs of violence in individuals, how to implement a workplace violence prevention program, and more.

The American Nurses Association (ANA) has a free downloadable #EndNurseAbuse resource guide that encourages nurses to send an email to their legislators to end violence against nurses, shows how to report all abuses, and offers strategies nurses can use to protect themselves on the job.

At this time, the ANA notes that OSHA doesn’t require employers to implement workplace violence prevention programs, but it provides voluntary guidelines and may cite employers for failing to provide a workplace free from recognized serious hazards. The ANA notes that many states have laws designating penalties for assaults that include nurses and other health professionals.

In addition, the American Association of Critical Care Nurses has a free downloadable guide, “Standards for Establishing and Sustaining Healthy Work Environments,” which discusses skilled communication, true collaboration, effective decision-making, appropriate staffing, meaningful recognition, and authentic leadership.

Bassett Healthcare Network in New York has given nurses and other staff a wearable emergency alert system that allows them to discreetly call coworkers or security in the event of an emergency. The Strongline Staff Safety System uses Bluetooth technology and attaches to a nurse’s badge.

All nurses should feel safe in their workplace and have the tools and support needed to combat bullying, violence, incivility, and toxic environments.

Anglade, D., Saber, D., Gattamorta, K., & Piehl, D. (2019). 

Evaluating horizontal violence and bullying in the nursing workforce of an oncology academic medical center,

Portrait of a Modern Nurse Survey Finds Half of Nurses Consider Leaving the Profession,

3. Vessey, J., DeMarco, Rosanna. Gaffney, Donna, Budin, Wendy (2009).

Bullying of staff registered nurses in the workplace: a preliminary study for developing personal and organizational strategies for the transformation of hostile to healthy workplace environment

National Nurse Survey Exposes Hospitals’ Knowing Failure to Prepare for a COVID-19 Surge During Flu Season,

August 2021

Number of Health Care Jobs Still Down From End of 2020

Hospice Professionals Use Mind, Body, and Movement Meditation to Reduce Stress

The Evolving Role of the APRN in Oncology Care

Oncology Nurses Are Champions Every Day

Stay Alert for Mental Health Issues Exacerbated by COVID-19 Pandemic

Continuing Education: August 2021

Neurotoxicity With Cilta-cel: Early Intervention Can Improve Outcomes in R/R Myeloma

Creating a Safe Space: Preventing Bullying and Violence Among Oncology Nurses