FDA Publishes Three New Biosimilars Resources for Healthcare Providers
To raise awareness and better educate patients and providers about biosimilars’ potential in clinical care, the U.S. Food and Drug Administration (FDA) added three new fact sheets to its healthcare provider resources in July 2022.
Single HPV Vaccine Dose May Be Enough to Prevent Cancer
In findings that could have global implications to change the face of female cancers, researchers reported that a single dose of the human papillomavirus (HPV) vaccine is highly effective in protecting young women against cervical infection with cancer-causing HPV types. The study results, which were published in NEJM Evidence, build on the body of evidence supporting single-dose HPV vaccines.
Promote Patient Self-Advocacy Across the Cancer Spectrum
Healthcare professionals are called to provide patient-centered care in an environment where they listen to patients’ goals and desires and support patient autonomy. However, heeding that call requires patients’ participation to voice their needs and concerns, and some patients may be reluctant to speak up for themselves.
Cancer Mortality Declines Among Black Patients but Remains Disproportionately High
Death rates fell about 2% per year from 1999–2019 for Black patients with cancer, researchers reported in study findings published in JAMA Oncology; however, the population’s cancer mortality remains higher than other racial and ethnic groups for most cancer sites.
What the Evidence Says About Traditional Chinese Medicine for Chronic Diarrhea
Diarrhea is a distressing condition that significantly affects patients’ quality of life and social functioning. Characterized by passage of more than three unformed stools in 24 hours, in cancer it can be caused by chemotherapy, radiotherapy, laxatives and antibiotics, enteral feeding, malabsorption syndromes, colectomy, or several types of malignant tumors. Diarrhea has also been reported in long-term cancer survivors. Standard treatment options such as opiate agonists and adsorbents are associated with side effects that may increase a patient’s symptom burden.
Oncology Nursing QI Project Shows Normal Saline Is Comparable to Heparin for Pediatric CVCs
Emerging evidence has consistently shown that flushing central venous catheters with normal saline is comparable to heparin flushes in the adult care setting, leading to updated guideline recommendations that include saline as an alternative. But to date, only two studies have evaluated the two options in pediatric patients, the older of which found increased complications when used in children with leukemia or lymphoma. Is normal saline an acceptable alternative in that population?
Genetic Disorder Reference Sheet: Multiple Endocrine Neoplasia Type 1
Multiple endocrine neoplasia type 1 (MEN1) is a rare autosomal dominant genetic disease affecting about 1 in 30,000 people. Pathogenic variants in the MEN1 gene are associated with benign and malignant tumors in the parathyroid glands, pituitary gland, pancreas, duodenum, and stomach.
Healthcare Organizations Advocate for Clinical Trial Diversity in Letter to Congress
Healthcare organizations advocated to improve diversity among clinical trials in a letter sent to U.S. Congress in May encouraging the government to take steps as the reauthorization of the Prescription Drug User Fee Act (PDUFA) approaches. The PDUFA allows the U.S. Food and Drug Administration to review and approve drugs, but the authorization is set to expire in September of 2022.
FDA Says It’s Continuing to Evaluate Pulse Oximeters’ Race-Related Accuracy and Limitations
More than a year and a half after a report suggesting a potential racial bias in pulse oximeter technology first surfaced as a letter to the editor in the New England Journal of Medicine (NEJM), on June 21, 2022, the U.S. Food and Drug Administration (FDA) said that it is continuing its investigation into the devices’ accuracy and performance, particularly among people of color.
Maintain Oral Adherence With ONS Guidelines™
With so many of today’s cancer treatments administered orally, ensuring that patients adhere to their regimen as prescribed is essential to optimal outcomes. According to the World Health Organization, medication adherence is the single most important modifiable factor that affects treatment outcomes.
Naive T-Cell Depletion Prevents Chronic GVHD in Transplantation Survivors
A novel stem cell transplantation strategy reduces both the incidence and severity of chronic graft-versus-host disease (GVHD) in patients with acute leukemia, researchers reported in the Journal of Clinical Oncology. The investigational treatment removes naïve T cells from donor cells before transplanting into patients.
Decree Houses ARPA-H Under NIH Oversight
Since President Joe Biden announced the creation of the Advanced Research Projects Agency for Health (ARPA-H) in October 2021, the National Cancer Institute and National Institutes of Health (NIH) shared responsibility for implementing its goals to improve the U.S. government’s ability to speed biomedical and health research. In April 2022, the U.S. Department of Health and Human Services (HHS) officially placed the agency under NIH.
Spring Clean Your Home and Heart
Slowing down to recenter can often feel unrealistic amid a nurse’s competing priorities. However, cultivating internal and external stability can improve life at the bedside and beyond. A clean home and heart can make it easier for us to navigate day-to-day responsibilities and engage in the love and relaxation we deserve as the day winds down.
Use the Evidence to Integrate Ethics in Teleoncology Care
Emily manages a rural clinic associated with an academic cancer center. Patients initially have an in-person consultation with their treating oncologists at the main campus but then use telehealth for subsequent visits. To support patients during teleoncology visits, Emily wants to initiate a plan to collaborate with the clinic staff to identify and address the ethical principles for oncology care using telehealth.
AI Ultrasound Is Nearly 100% Accurate in Detecting Thyroid Cancers
Ultrasound imaging guided with artificial intelligence (AI) noninvasively detects almost all malignant thyroid nodules, researchers reported at the 2022 Multidisciplinary Head and Neck Cancers Symposium. It is also accurate when predicting T stage, extracapsular extension, and presence of a BRAF variant.
Oncology Navigation Standards Help Patients Overcome Disparities and Barriers to Care
Patients with cancer, especially those from underrepresented groups or who are experiencing racism, inequalities, social determinants of health factors, and other barriers to care, need oncology nurse navigation now more than ever before. Developed as a “strategy to improve outcomes in marginalized populations by eliminating barriers to timely diagnosis and treatment of cancer and other chronic diseases,” navigation has made a difference for patients since its introduction in 1990.
U.S. Representative Pallone Questions Vaping Companies on Teen Marketing
As the U.S. Food and Drug Administration (FDA) continues its review of tobacco and e-cigarette products’ marketing applications, legislators and government officials, such as Energy and Commerce Committee Chair Frank Pallone, Jr. (D-NJ), are taking a stand and sharing their concerns on Big Tobacco’s marketing to teenage audiences.
More Patients Are Skipping Their Cervical Cancer Screenings
Nearly a quarter of patients who are eligible for cervical cancer screening are overdue for their current tests, researchers said in study findings published in JAMA Network Open. The number grew nearly 10% since 2005—representing a steady increase in missed screening over time—and was higher in different sociodemographic groups because of factors related to social determinants of health.
CAR T-Cell Therapy Programs
Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.
Robert Otto Valdez Appointed AHRQ Director
Internationally recognized for expertise in health services research, the U.S. healthcare system, and health policy analysis, Robert Otto Valdez, PhD, MHSA, was appointed as director of the Agency for Healthcare Research and Quality (AHRQ) in February 2022, where he leads the agency’s work in improving and promoting patient safety.
Younger Nurses Are Leaving the Profession Because of Emotional Health
Young nurses are “less emotionally healthy and less optimistic about the future,” even after accounting for age and years of nursing experience, according to findings from a 2022 study conducted by the American Nurses Foundation. High levels of burnout correlate with drones of professionals leaving the nursing field, the foundation said in its Pulse on the Nation’s Nurses Survey Series: COVID-19 Two-Year Impact Assessment Survey.
What the Evidence Says About Low-Intensity Exercise in Cancer Care
Regular, light-intensity exercise and activity has been shown to reduce the risks of fractures, heart disease, and death. Substantial evidence also indicated benefits for cancer-related outcomes, including fatigue, depression, and quality of life. Additional observational data suggested that sustained physical activity may help reduce cancer recurrence and improve overall survival.
Nursing Diversity Is Critical to Address Health Disparities
Following the death of George Floyd in May 2020, I found myself surrounded by oncology nurses who recognized the need for immediate action to understand and deconstruct racism, and I began collecting resources to offer continuing education about the effects of racism on cancer outcomes and actions nurses can take to support health equity and diversity in the workforce. Under the mentorship of ONS Past President Mary Gullatte, PhD, RN, ANP-BC, AOCN®, FAAN, I was charged by ONS to co-lead, with ONS member Randy Jones, PhD, RN, FAAN, a national team of ONS cancer disparities and health equity researchers to update the ONS Research Agenda.
E-Cigarettes Affect Adults and Kids Differently, FDA Center for Tobacco Products Director Says
Balancing the benefits of e-cigarettes for adults with the harms makes regulating e-cigarette marketing particularly challenging, U.S. Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller, JD, said in a January 2022 interview with the National Cancer Institute (NCI). FDA continuously evaluates e-cigarettes and tobacco companies’ marketing strategies, and Zeller says it’s up to tobacco companies to make those differences clear in their advertising.
New HHS Initiative Will Reduce Maternal and Infant Health Disparities
To reduce the disparities affecting maternity health outcomes, the U.S. Department of Health and Human Services (HHS) Office on Women’s Health (OWH) launched the Maternal Morbidity and Mortality Data and Analysis Initiative, an $8 million contract with Premier, Inc., the agency announced in December 2021. The initiative is rallying a network of hospitals to deploy evidence-based best practices in maternity care.
Families See Increase in Healthcare Premiums, Increase in Covered Services
Employer-sponsored health insurance premiums increased by 4% for families in 2021, bringing the average annual cost to $22,221 per family, according to the results of a benchmark Kaiser Family Foundation (KFF) Employer Health Benefits survey released in November 2021. KFF also assessed the COVID-19 pandemic’s impact on workplace health benefits, including telemedicine and mental health services.
Local Policies Have Reduced Availability, Use of Flavored Tobacco Products
Local policies have reduced the availability and youth and adult use of products like flavored e-cigarettes and menthol cigarettes compared to areas without restrictions, the Truth Initiative reported after the first comprehensive quality review that looked at the outcomes of flavor and menthol tobacco restrictions. The research, which was conducted in partnership with the Research Triangle Institute, was published in Nicotine and Tobacco Research.
Black Patients at Higher Risk for Infection, Poor Outcomes From COVID-19 During Cancer
Patients with cancer are more likely to contract the COVID-19 coronavirus and experience complications from the infection—and the risk is highest for Black patients, study findings show. Researchers published the report in JAMA Oncology.
Racism, Health Inequities, and Unequal Access to Care Are Oncology Nursing Research Priorities
Racial inequality persists across the entire healthcare spectrum—from patient disparities to the healthcare workforce’s current makeup and even to the education of the next generation of practitioners. But nurse scientists conducting clinical trials have the opportunity to change that.
Patients Cope With Intense Emotions After Clinical Trial Withdrawal
When withdrawing from a clinical trial, patients experience a spectrum of emotions ranging from regret, urgency, frustration—and trust in their healthcare professionals, like oncology nurses, according to the results of a study published in JAMA Network Open.
Biden Brings Robert Califf Back to FDA
Citing his extensive medical background and leadership experience, in November 2021, President Joe Biden nominated Robert Califf, MD, MACC, adjunct professor of medicine, professor of cardiology, and member of the Duke Clinical Research Institute at the Duke University School of Medicine in Durham, NC, as U.S. Food and Drug Administration (FDA) commissioner. Califf will assume the role once confirmed by the U.S. Senate.
FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Genetic Disorder Reference Sheet: Familial Adenomatous Polyposis
Individuals with 10–100+ polyps may have a germline pathogenic variant in the APC gene, placing them at higher risk for developing colorectal, gastrointestinal, and other cancers. The condition is known as familial adenosis polyposis (FAP), and loss of function in the APC gene is the first step in the adenoma-to-carcinoma sequence. Some people have an attenuated form (aFAP), with delayed polyp growth and fewer polyps (see sidebar). As many as 20% are de novo, meaning that they are the first in their family to have an identified pathogenic variant.
Bringing Biosignatures to the Bedside
With the growth of genomics and targeted therapy, nurse scientists are gaining deeper understanding the vast facets of patients’ symptom experience, and biosignatures could be the key to unlocking the next frontier in symptom science research.
Combination Immunotherapy May Further Increase Melanoma Survival Length
Using two agents that target two different receptors more than doubles length of survival for advanced melanoma than a single agent alone, researchers reported at the 2021 American Society of Clinical Oncology annual meeting.
Genetic Disorder Reference Sheet: ATM Pathogenic Variants
An estimated 1%–2% of adults have one pathogenic ataxia telangiectasia mutated (ATM) gene variant (heterozygous) and are considered carriers. People who are homozygous (two altered copies) have ataxia-telangiectasia (A-T), a hereditary condition that often appears in childhood and is characterized by progressive neurologic problems that lead to difficulty walking and an increased risk for developing various malignancies. Children with A-T may begin staggering and appear unsteady (ataxia) shortly after learning to walk.
FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency
On October 13, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of five lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level because the firm’s testing found it to be super potent based on an out-of-specification result obtained at the 18-month stability timepoint.
HER2 Therapies May Be Effective in a Variety of Solid Tumors
Researchers have found that 2%–3% of all solid tumors overexpress or amplify HER2 protein that may be a target for drugs such as pertuzumab and trastuzumab, particularly in KRAS-variant disease. They presented their findings during the 2021 American Society of Clinical Oncology annual meeting.
Pilot Study Shows Positive Impact of ONS Get Up, Get Moving Campaign
PITTSBURGH, PA—October 12, 2021—Research shows that physical activity during cancer treatment mitigates some of the negative physical and psychosocial outcomes associated with diagnosis and treatment. Released in the October 2021 issue of the Clinical Journal of Oncology Nursing, results of a pilot study by Judi K. Forner, DNP, APRN, ACNS-BC, RN-BC, Andrea Doughty, PhD, Matthew David Dalstrom, PhD, MPH, Brandie L. Messer, DNP, RN, PCOE, and Shannon K. Lizer, PhD, APRN, FNP-BC, FAANP, demonstrated the positive impact of the Oncology Nursing Society’s (ONS’s) Get Up, Get Moving program.
It Takes a Team to Confront Moral Distress
Unbearable levels of stress, burnout, frustration, disappointment, and even fear are plaguing today’s healthcare providers more than ever before. But for oncology nurses, moral distress and compassion fatigue have always been in the background when caring for patients with a serious illness.
PhD and DNP Students Collaborate to Implement Practice-Driven Research
Evidence-based practice is dual sided: nurse scientists conduct research, and clinical nurses implement those findings into practice. Working together, they improve care by developing cancer survivorship programs, reducing cancer risk, and assessing cancer care in vulnerable populations. The University of Washington School of Nursing’s (UW SoN’s) partnership with Confluence Health, one of the largest healthcare providers in north central Washington, built a novel program to identify gaps in research and implementation and elicit projects that influence healthcare outcomes.
FDA Issues Marketing Denial Orders for 55,000 Flavored E-Cigarette Products
In August 2021, the U.S. Food and Drug Administration (FDA) denied about 55,000 flavored e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
On September 22, 2021, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose administered at least six months after completion of the primary series in individuals aged 65 and older, individuals aged 18–64 at high risk for severe COVID-19, and individuals aged 18–64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk for serious complications of COVID-19 or severe COVID-19.
What the Evidence Says for Traditional Chinese Medicine Ma Zi Ren Wan for Constipation
A common and distressing symptom among patients with a variety of health diagnoses as well as the general population, constipation is characterized by reduced stool frequency, incomplete evacuation, straining, and a sense of anorectal blockage. Nearly 43%–58% of patients with cancer report constipation caused by a variety of factors, including organic, functional, or drug associated. Standard treatment options such as fiber supplements, laxatives, and stool softeners are not entirely effective and can cause adverse effects.
FDA Reprimands Tobacco Company for Not Meeting Premarketing Filing Requirements
On August 9, 2021, the U.S. Food and Drug Administration issued a refuse-to-file letter (RTF) to JD Nova Group, notifying the company that their premarket tobacco product applications associated with approximately 4.5 million of their products do not meet the filing requirements for a new tobacco product seeking a marketing order.
How One Organization Developed Tools to Predict Opioid Use Disorder Among Patients
Opioids are one strategy to help manage the cancer-related pain that nearly 75% of patients with cancer experience throughout the disease or its treatment. However, the prevalence of opioid misuse disorder (OUD) among patients with cancer is believed to be at least equal to that of the general population, Debra Rodrigue, MA, RN-BC, AOCNS®, explained during a session for the ONS BridgeTM virtual conference on September 9, 2021.
Prognostic Biomarkers May Help Predict Rhabdomyosarcoma Outcomes
TP53 and MYOD1 variants are associated with more aggressive forms of rhabdomyosarcoma, a rare childhood cancer, and poorer outcomes, according to the results of the largest international genomic profiling study of the disease. The findings, which were published in the Journal of Clinical Oncology, have implications for somatic biomarker testing to guide tailored treatment approaches.