Monumental strides in cancer treatment have been made in recent years, though there is still far more work to be done when it comes to cancer screening and diagnostic procedures, according to the American Cancer Society’s “Blueprint for cancer research: critical gaps and opportunities.”

“With only 4 of the 20 most common cancer types in the United States having a proven screening method to reduce mortality by identifying early-stage lesions, developing such tools for other high-incidence malignancies is urgently needed,” the 

The American Cancer Society worked with experts in the field to establish research opportunities that could lead to the development of better screening approaches in the future. They included:

Better understanding the molecular makeup of early-stage cancer and premalignant disease

Determining how the tumor microenvironment leads to the transition of premalignant to preinvasive to invasive disease

Creating better technologies for screening, early detection, and risk stratification

Improving the ways that biomarkers are analyzed and detected with a limited amount of fluid

Establishing how public health genomics can affect precision public health when it comes to cancer screening and earlier detection

Find ways to use artificial intelligence or machine learning and next-generation technologies (wearable devices, etc) to help in cancer screening and early detection.

Despite the existence of these major gaps, there have still been significant strides in diagnosing cancer and better understanding the disease biology.

For example, thanks to the advent of liquid biopsy, patients can undergo a blood test that provides vital information about circulating tumor cells, free tumor-derived DNA or RNA and cancer-derived exomes.

“A liquid biopsy offers many advantages over a traditional biopsy,” the report says. “It is minimally invasive, not generally limited in terms of sample accessibility and availability, and practical for repeat sampling, which could help clinicians during screening and surveillance as well as postdiagnosis to better understand the molecular changes occurring in a tumor over time.”

Additionally, every year researchers learn more about cancer biomarkers, and these discoveries continue to serve as the backbone for more personalized, efficacious cancer treatment.

Authors of the report hope that advances in genomics, proteomics, metabolomics, and lipidomics will further be used to develop better cancer screening as well as improve the cancer screening methods that are currently available — though those efforts have not yet been fruitful.

“With the advancement of metabolic profiling technologies, there have been notable efforts over the past decade to clinically exploit cancer-specific metabolism to aid in cancer detection,” the report says. “Thus far, translation and clinical utility have been somewhat disappointing.”

Ultimately, while 2020 did have scientific discoveries that will improve cancer treatment, there is still plenty of work to be done in 2021 and beyond.

Articles

Only 4 of the 20 most common cancers have a proven screening method.
 

Better Cancer Screening Is Needed: Hopes for 2021 and Beyond

Each month, we take a look back at the most popular 

 stories. Here are the top 5 stories from July 2020.

5. Dexamethasone Is Affordable and Promising in Treating COVID-19

As the coronavirus 2019 (COVID-19) pandemic continues, research efforts have revealed a potential weapon to add to the treatment arsenal against the virus, a drug that has historically played a crucial role in oncology treatment: the inexpensive, and widely accessible, 

4. Why Be an Oncology Nurse? A Patient Perspective 

Like many people, Jane Biehl, PhD, thought she knew what the field of oncology was all about — 

. Here, she details how her own experience as a patient with cancer has taught her all about the compassion and love found in oncology nurses.

3. Immunotherapy Does Not Increase Death Risk in Patients With COVID-19

According to new findings presented during the 2020 AACR Virtual Meeting: COVID-19 and Cancer, treatment with 

 did not increase the risk of mortality in patients with COVID-19 and cancer. Learn more in this recap.

2. Cancer Organizations Advocate for US to Remain in the World Health Organization

Leading cancer organizations and members of Congress recently wrote a letter to the White House advocating that the 

United States remain in the World Health Organization

 (WHO) after President Trump stated earlier this month that the US will withdraw from WHO.

1. Mental Health Treatment May Improve Cancer Outcomes

 may want to encourage patients to seek help, according to a recent study published in 

. Read more about these findings in this web exclusive.

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from July 2020.

Oncology Nursing News Top Stories: July 2020

 indicated that there has been a significant nationwide decrease in all cancer-related patient encounters as a result of the coronavirus disease 2019 (COVID-19) pandemic.

The findings also inherently suggest the possibility of a future increase in patients with later-stage cancer being seen, as well as an increased demand for cancer screening procedures due to delayed tests being rescheduled.

“These findings are truly striking, as modeling from the National Cancer Institute has predicted thousands of expected increases in cancer death as a result of deferred breast and colorectal screening alone,” Karen E. Knudsen, MBA, PhD, executive vice president of Oncology Services at Jefferson Health and enterprise director of the Sidney Kimmel Cancer Center (SKCC), said in a press release.

 “This report is a nationwide call to arms, underscoring the urgent need to resume cancer screening and early detection.”

Using the TriNetX platform, researchers analyzed 20 different healthcare institutions with relevant, up-to-date encounter data from January 1, 2019 through April 30, 2020 to create the COVID and Cancer Research Network (CCRN). They then compared the data from cohorts of patients with cancer pre-COVID (January 2019 to April 2019) to current cohorts (January 2020 to April 2020). Notably, cohorts were generated for all patients with neoplasms (malignant, benign, in situ, and of unspecified behavior), with new incidence neoplasms (first encounter), with exclusively malignant neoplasms, and with new incidence malignant neoplasms.

Overall, unambiguous trends were identified which suggested a significant decline in all current cohorts evaluated, with April 2020 displaying the largest decrease in the number of patients with cancer having encounters. More specifically, among the cancer types identified, the lung, colorectal, and hematologic cancer cohorts demonstrated smaller decreases in size in April 2020 versus 2019 (-39.1%, -39.9%, -39.1%, respectively) compared with cohort size decreases for breast cancer, prostate cancer, and melanoma (-47.7%, -49.1%, -51.8%, respectively).

In addition, the investigators also found that mammograms declined 89.2% in April 2020 compared with April 2019, and colorectal cancer screenings declined by 84.5% during the same period. Moving forward, the researchers indicated that they intend to track screenings in the coming months as virus mitigation efforts are eased to help predict how many patients are continuing to delay cancer screenings due to the pandemic.

“The most significant finding in our study was the considerable drop in cancer screenings. The fact that this trend was so drastic nationwide is telling of the widespread effect of the pandemic and mitigation efforts — even in regions that had not seen a significant impact from the virus at the time,” senior author Christopher McNair, PhD, director of Cancer Informatics at SKCC, said in the release.

Throughout the summer and into the fall, the researchers will continue to observe the trends in care of patients with cancer, especially as more states become more drastically affected. According to McNair, it will be important to understand trends in cancer diagnoses to determine if delays in screening are resulting in an increased number of patients presenting with later-stage disease.

“Ultimately, these observed trends have serious implications for future cancer care and validate the need to study and monitor the effect of COVID-19 mitigation on cancer diagnosis and treatment moving forward,” the study authors wrote.

1. London JW, Fazio-Eynullayeva E, Palchuk MB, Sankey P, McNair C. Effects of the COVID-19 Pandemic on Cancer-Related Patient Encounters. JCO Clinical Cancer Informatics. doi:10.1200/CCI.20.00068.

2. Nationwide Trends Show Fewer Cancer Patients Seeking Care Since Start of Pandemic [news release]. Philadelphia. Published July 27, 2020. Accessed July 28, 2020.

These findings have serious implications for future cancer care and underscore the need to resume cancer care and screening.

Nationwide Decrease Seen in Cancer-Related Encounters Due to the COVID-19 Pandemic

While it is known that malnutrition is associated with poorer outcomes in pediatric patients with cancer, oncology nurses were more inclined to under-rate nutritional status, according to a recent study published in the 

The investigators sent electronic surveys to oncology nurses that included patient vignettes that examined nurses’ decision making when it came to nutritional assessment of children over the age of 2 with cancer. Factors included nutritional rating, confidence in rating, and selection of cues that support the nutritional rating. A total of 318 nurses participated.

Nurses rated the vignettes on a scale of 1 to 5, with 1 being undernourished and 5 being over-nourished.  The participating nurses’ answers were then compared to the ratings of a team of experts, comprised of a master’s prepared pediatric oncology nurse, 2 pediatric oncology-registered dieticians, and an epidemiologist researcher of nutrition in pediatric oncology patients.

Nurses chose the same answers as the experts 41% of the time.

“While the mean score of the participants’ ratings were similar to the expert panel, there was considerable individual variation indicating significant differences in clinical decision making between staff nurses and experts,” the researchers wrote.

The nurses that participated were somewhat younger (average 39 years old), more educated (90% had a least a bachelor’s degree and 72% certification rate) and worked in environments known to be high performance settings (66% Magnet® institutions, 86% Children’s Oncology Group). Because of these factors, the study authors predicted that the nurse participants in the study would perform as well as, if not better, than the average nurse in the US.

“The most notable finding regarding the accuracy of participants’ ratings was nurses were significantly more likely to underrate rather than overrate nutritional status,” the authors wrote. “The participants’ ratings, on average, were below the experts’ ratings; the degree of difference increased as the patient depicted in the vignette became more nourished.”

By underrating nutritional status, nurses may be causing certain patients to undergo unnecessary nutritional interventions, putting them at risk for over-nourishment, which could lead to increased risk for morbidity and mortality, the researchers explained.

“Patients being treated for acute lymphoblastic leukemia, the largest portion of pediatric oncology patients, trend toward over-nutriton,” they wrote. “Thus, not recognizing overnutrition in this population could be placing a large percentage of pediatric oncology patients at risk.”

When it came to cue selection, study participants matched the experts only 16% of the time. Notably, the nurses recognized far fewer cues.

“If participants are selecting fewer and/or different cues, it follows that they would determine a different rating of the patients’ nutritional status,” the authors wrote. “Different ratings can lead to different, or no, interventions.”

In particular, participating nurses were far less likely to consider anthropometric variables (height, growth, weight, weight loss). Not only is this important when analyzing nutritional status, but also in properly dosing chemotherapy drugs.

Another discrepancy between nurses and the experts was the consideration of albumin as supporting cues. The experts never selected albumin as a cue, while the nurses selected it more than half of the time (53%).

The findings of this study outlined an important need for oncology nurses to better understand nutritional status in pediatric patients.

“Because nutrition plays a vital role in children’s growth and development as well as their health and healing, oncology nurses need to be well-versed in the nutritional assessment of their patients,” the researchers wrote.

Looking ahead, the researchers said that a standardized nutritional assessment tool for pediatric oncology patients should be implementd. “This can be done through tool development, or through widespread testing, refinement and utilization of the current tools available.”

Lulloff AJ, Vessey JA, Bashore L, Gregas M. Nutrition-Related Clinical Decision Making of Pediatric Oncology Nurses. 

. 2019;36(5):352-360. doi:2083/10.1177/1043454219844233.

Understanding nutritional status and patient cues is crucial in ensuring patients have the proper interventions and treatment plans.
 

Nutritional Status Misjudged by Pediatric Oncology Nurses

Quite simply, there is no good or harm-free exemplar of smoking. Tobacco use entails embarking on a slow course of ruining your life, which is why I am vigilant when it comes to the subject. My father and husband died from cancer caused by long-term tobacco exposure. It is also impossible for me to count how many patients I have cared for over the years who have voiced their regrets for trying that first cigarette.

A disclaimer is in order here. I have never smoked. In 8th grade, we were shown a movie about the dangers of tobacco, which included a graphic picture of blackened lungs that scared me. I went home and made a plea to my parents who both smoked, to stop. For most, however, it is not that simple. Nicotine addiction is extremely difficult to overcome.

Now we have a new tobacco-related epidemic on our hands: vaping. The old record from decades ago about the absence of harm from tobacco has been dusted off and replayed,

but the target for current marketing efforts is different. Children, mostly teenagers, are the focus. The deceit has been so significant that in September of this year, the FDA threatened sanctions against Juul Labs, a major producer of vaping products, for erroneous and misleading marketing to children and teenagers about the “less harmful” nature of e-cigarettes.

Electronic nicotine delivery systems (ENDS) are designed to aerosolize liquids for inhalation. These devices include e-cigarettes, vaporizers, hookah pens, and tank systems, predominantly used to inhale nicotine and cannabis-based compounds. E-cigarettes entered the US market around 2007, and since 2014, they have been the most commonly used tobacco products among youths nationally.

By 2018, there were 288 models of ENDS on the market and more than 15,500 flavors, referred to as juices.4 Vaping behaviors also escalated considerably in high school students between 2017 and 2018.5 An extensive review of monitoring results of over 43,000 students in 8th, 10th, and 12th grades between 2017 and 2018 revealed vaping-related incidences more than doubled in each of these 3 grades. In 2019 alone, the prevalence of vaping in the 30 days before student survey completion was more than 1 in 4 students in 12th grade, more than 1 in 5 in the 10th grade, and more than 1 in 11 in the 8th grade.

 The range of flavor options and the perceptions that vaping is relatively healthy and more socially acceptable than tobacco are considered to be the major drivers in this dramatic increase in use.

As vaping continues to become a widespread issue, many are concerned with its connection to pulmonary diseases. Researchers studied the clinical courses of 53 patients who

were identified in acute-onset pulmonary disease clusters in Wisconsin and Illinois.

Fifty patients were hospitalized, 32% of whom required intubation and mechanical ventilation; 1 death was reported. The median age of these patients was 19 years. All reported e-cigarette device used before the onset of symptoms, the majority of which (84%) inhaled tetrahydrocannabinol products.

Several recent reports detailing biopsy and radiological findings are of particular interest to researchers and public health officials. The acute lung injuries associated with vaping

were primarily identified as hypersensitivity pneumonitis, diffuse alveolar hemorrhage, and histopathologic variations of pneumonia.

 The causes remain speculative, but potential etiologies cited include the aerosolization of flavoring compounds, adulteration of devices with tetrahydrocannabinol-based oils or vitamin E, and use of black market vaping products.

The most recent report of a negative vaping corollary was the development of lung and bladder primary cancers in an animal model where short-term (12 weeks) e-cigarette smoke exposure in mice was associated with the presentation of these malignancies.

The United States needs to set a global example for the prevention of ENDS-related illnesses. To do this, 4 phenomena must be addressed:

1. The young age of ENDS users is of utmost concern. Continuous, unconstrained use of ENDS in this demographic represents the first generation

of teenagers in the modern world to be allowed to put their health and longevity at risk, unchecked, with alleged long- term negative corollaries.

2. The addictive nature of nicotine, especially in young individuals, cannot be ignored. Efforts to protect youth from using nicotine during adolescence is imperative. The developing brain is particularly susceptible to permanent changes from nicotine use.

 Results of epidemiological studies have also shown that smoking in this age group is a first step toward heroin and cocaine addiction.

 Chemical changes in dopamine-receiving neurons induced by nicotine are likely to disrupt the brain’s normal reward circuitry and prime the brain for enhanced sensitivity to potentially abusive substances.

3. Vaping may increase the incidence of dual users of nicotine products. There is growing evidence that rather than substitute conventional tobacco for e-cigarettes, there are more dual users—those who vape and smoke cigarettes.

4. ENDS may be linked to future cases of lung cancer.5 Due to the contemporary nature of this epidemic, the long-term consequences of this health risk are unknown. However, due to historical data associated with nicotine use, it is highly suspect that a link between e-cigarettes and cancer will unfold.

Oncology nurses must keep up with the evolving scientific basis of the perils of vaping.

As trusted educators, we need to maintain informational vigilance about this health hazard. This topic may evolve in discussions with patients as the use of cannabis products during cancer treatment is deliberated. It may also present as patients and families voice concern about their children’s or grandchildren’s use of ENDS. I don’t feel this phenomenon will go away soon, which is all the more reason to focus on our evidence-based astuteness as we advocate for patients and families and perhaps our own loved one.

Marcham CL, Springston JP (2019). Electronic cigarettes in the indoor environment. 

Warning letter to JUUL Labs; accessed 10/10/2019; 

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/juul-labs-inc-590950-09092019

Surgeon General’s advisory on e-cigarette use among youth. Washington D.C.: Department of Health and Human Services, Office of the Surgeon General, 2018 (

https://e-cigarettes.surgeongeneral.gov/documents/surgeon-generals-advisory-on-e-cigarette-use-among-youth-2018-pdf

Henry TS, Kligerman SJ, Raptis CA, Mann H, Sechrist JW, Kanne JP (2020). Imaging findings of vaping-associated lung injury. 

Author (2019). Vaping-related lung illnesses: Time to act. 

Miech R, Johnston L, O’Malley PM, Bachman JG, Patrick ME (2019). Trends in adolescent vaping, 2017-2019. 

Layden JE, Ghinai I, Pray I et.al. (2018). Pulmonary illness related to e-cigarette use in Illinois and Wisconsin — Preliminary report. 

Butt YM, Smith ML, Tazelaar HD et.al. (2019). Pathology of vaping-associated lung injury. 

Hswen Y, Brownstein JS (2019). Real-time digital surveillance of vaping-induced pulmonary disease. 

Tang M, Wu X, Lee H et.al. (2019). Electronic-cigarette smoke induces lung adenocarcinoma and bladder urothelial hyperplasia in mice. 

Yuan M, Cross SJ, Loughlin SE, Leslie FM (2015). Nicotine and the adolescent brain. 

Kandel ER, Kandel DB (2014). A molecular basis for nicotine as a gateway drug. 

The Disordered Mind: What Unusual Brains Tell Us About Ourselves. 

Brandon KO, Simmons VN, Meltzer LR et.al. (2019). Vaping characteristics and expectancies are associated with smoking cessation propensity among dual users of combustible and electronic cigarettes. 

Giovenco DP, Delnevo CD (2018). Prevalence of population smoking cessation by electronic cigarette use status in a national sample of recent smokers. 

Tobacco use among young people is an old problem that now challenges a new generation in a new form: vaping.

Vaping Presents an Old Danger to a New Generation

The emergence of biosimilars in cancer care has the potential to relieve some of the financial burden related to drug costs, as well as increase sustainable growth within the field, explained Bradley G. Somer, MD.

“[Biosimilars] is an expanding field, and we have a lot of different options. It is important to dedicate some focus on [biosimilars], because you can come up with the best game plan and best product to implement for your practice,” Somer said. “It's going to be a rapidly developing field as more options become available on a rapid-fire basis.”

, Somer, medical oncologist, senior partner of the Executive Cancer Council, and head of Strategic Expansion/Development of West Cancer Center, and an associate professor in the Department of Hematology and Medical Oncology at the University of Tennessee Health Science Center, discussed the emergence of biosimilars in oncology and their financial implications for patients with cancer.

: What are your thoughts on the approvals of biosimilars in oncology?

: [The arrival] of biosimilars is very exciting because it gives us additional options that are of lesser cost and create a more sustainable system in oncology. The most significant issues in oncology, as we're getting all these amazing advances in cancer therapy, are that the expense and the rate of growth are not sustainable.

We, as a community, need to come up with a game plan in terms of how to make care more affordable and allow us to continue the development of newer therapies, in order to make this explosion something sustainable. Biosimilars are one part of that and hopefully, it's the beginning of more to come. There are other areas, such as comprehensive care, decreasing hospitalizations, and more that could lower costs, but biosimilars will be major in [decreasing the financial strain of] oncology.

How will the availability of biosimilars impact the cost of reference products?

The market share will likely drop in terms of the reference product because people are going to be using some of those biosimilars. Unless there are expanded indications, which hopefully that will continue to be, there will probably be a shift in the metastatic or palliative setting toward these lower cost alternatives.

Has there been hesitancy with physicians getting on board with biosimilars in practice?

When something is new, it always takes time. When you have comfort using [agents] the way that you have been using them, it's hard to veer from that. There is so much to learn in oncology in terms of efficacy and safety, so to veer off into [a value-based approach] is something that your average oncologist or oncology practice isn't going to focus on—unless you're sophisticated enough or have interest to explore that. There is so much information that is out there and our minds are only so big. It's been a challenge that takes a lot of education, strategy and focus from a practice perspective.

What are some ways that physicians can better educate themselves on biosimilars?

In general, [physicians can educate themselves] the same way that they would get educated on anything related to efficacy: using medical education programs. Additionally, when we go to ASCO, ESMO, and other medical conferences, [biosimilar education is] something that has to be front and center. There are comparative studies that are being done, but the conversation has to continue to develop in terms of whether we can go apply [the data with biosimilars to practice]. Where do we stop? That has to be an ongoing conversation.

Ultimately, the decisions have to be made based on what we are doing, [and ensuring] that is best for our patients and society. When we get a patient, we're thinking about that [individual] patient in front of us and we're never going to veer from that. However, as a system—both as a large practice or as a society in general&mdash;we have to think about it more holistically and come up with the best game plan to give the best value, without changing efficacy. As long as there is no change in efficacy, you can get by with the better value option.

For more on financial toxicities, read on 

A version of this article originally appeared on OncLive

Emergence of Biosimilars Poised to Alleviate Financial Toxicity in Oncology

Biosimilars are beginning to change the way oncology professionals treat patients with cancer, and this could help alleviate the financial burden of care. 

Expert Believes Biosimilars Can Help Address Financial Toxicity

October is recognized as Breast Cancer Awareness month, and it is difficult not to notice the theme at every turn, from worldwide landmarks with pink lights—Buckingham Palace, the White House, and Tokyo Tower, to name a few&mdash;to professional athletes altering their uniforms with pink socks, sweatbands, and caps. During this month, you can also find seminars, conferences, and screenings centered around breast cancer. Advertisements on television and social media, too, are loaded with the color pink and the symbolic pink ribbon.

Despite all these efforts to bring awareness to breast cancer, as an African American woman, it is heartbreaking to read the statistics about my ethnic group and the treatment disparity that still exists in 2019. 

 reports that among African American women with breast cancer younger than 50 years old, they have a mortality rate double that of white women with breast cancer.

Not only are more aggressive forms of breast cancer diagnosed in African American women than white women

—such as triple-negative breast cancer (TNBC), which has limited treatments available and can’t be treated with hormonal therapies&mdash;but the disease is being diagnosed at more advanced stages. Contributing factors to these inequalities include social and economic disparities, cultural differences, biological differences, and lack of access to high-quality healthcare. The socioeconomic disparities stem from fewer opportunities and lack of access to resources, such as employment, income, education, housing, healthy foods, and standard of living compared to white Americans. The higher cancer burden may also reflect different rates of behavioral risk factors for cancer such as smoking.

Are we looking close enough at the biological differences? Why are black women more opt to develop TNBC that is most likely not due to a 

 Does socioeconomic status determine the type of breast cancer diagnosed in these women? Could there be a gene mutation expressed in black women that has not yet been identified? In order to dive further into the germline DNA, clinical trials need to include more African American women.

With what we already know, how can we begin to close this disparity gap? I believe knowledge is power and without knowledge, life is lost. Education is key to closing this gap. The American Cancer Society has done a lot of work to bring awareness to underserved communities through prevention and early detection programs and services, by providing transportation to treatment and lodging during treatment, and by assisting with navigation through the healthcare system.

 Community leaders, cancer advocates, health care workers, organizations, associations, and anyone who has an interest in the community must join forces to help bring their own awareness to the unique challenges that African American women with breast cancer face.

The technology is available, and new breakthroughs and treatments are continuing to be revealed, but African American women are not receiving many benefits from these advancements. Much work is still needed to improve the mortality rate and close the disparity gap of African American women with breast cancer.

DeSantis CE, Ma J, GHaudet MM, et al. Breast cancer statistics, 2019 [published online October 2, 2019]. 

Forster V. Breast cancer death rate continues to drop, but black women have far higher mortality rates. 

forbes.com/sites/victoriaforster/2019/10/02/breast-cancer-death-rate-continues-to-drop-but-black-women-have-far-worse-chance-of-survival/#681548922054

Cancer Facts & Figures for African Americans 2019-2021

. Atlanta, GA: American Cancer Society; 2019. 

cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2019-2021.pdf

The biology of cancer health disparities. National Cancer Institute website. 

cancer.gov/research/progress/discovery/biology-cancer-health-disparities

Despite advanced technology and new treatment breakthroughs in cancer care, treatment disparity remains among African American women with breast cancer.
 

African American Women Aren't Receiving the Benefits of Breast Cancer Awareness

The Food and Drug Administration (FDA) has issued a new draft guidance for labeling recommendations for breast implants to manufacturers that they hope will provide patients with more information on the benefits and risks associated with them.

The new draft guidance offers measures to make sure women have access to pertinent information concerning the implants, such as suggesting manufacturers include updated guidelines for rupture screenings. They proposed that patients without symptoms be screened using either ultrasound or MRI at 5-6 years after receiving implants and then every 2 years thereafter. If a patient has symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended. The FDA also hopes to provide easier access to information on both saline-filled and silicone gel-filled breast implants.

The new recommendations come after the FDA came under scrutiny for not addressing patient complications with breast implants. In March, the agency held a hearing where patients brought multiple issues to light about their breast implants and subsequent illnesses. The FDA came out of the hearing 

 on cancer and illness caused by breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While the FDA announced that it would 

 against BIA-ALCL, the organization had yet to issue new action until this week.

“We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information,” the agency said in a press release. “The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being considered.”

One of the major recommendations proposed by the FDA is to provide a boxed warning on the label of the breast implant. The label would include a warning that breast implants are not lifetime devices and the risk of developing complications increases the longer a patient uses the implant, which could lead to more surgery to address these complications. The warning would also include that breast implants have been associated with BIA-ALCL.

The FDA also recommends a patient decision checklist, which will allow patients to easily understand the risks associated with the breast implant, and if the implant is right for them. The agency recommends that the information in the checklist should include situations where the device should not be used, what makes a successful breast implant candidate, risks of undergoing breast implant surgery, importance of physician understanding and experience with breast implants, risk of BIA-ALCL, and alternative options to using breast implants. This checklist would also have the patient and physician initial that they have gone through the checklist together.

Other recommendations included adding product ingredient information simplified in a way for patients to read and understand. The abridged information is a way to provide patients with access to information that they otherwise wouldn’t get or have to ask their physician to explain to them. The FDA also would like manufacturers to provide the device’s unique identifier on the patient card in order for both the patient and physician to better track the device's information.

“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making healthcare decisions that fit patients’ needs and lifestyle,” the agency concluded in their statement. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”

Statement on the Agency’s Continued Efforts to Protect Women’s Health and Enhance Safety Information Available to Patients Considering Breast Implants. FDA. Published October 23, 2019. https://bit.ly/35WzONY. Accessed October 24, 2019.

Breast Implants-Certain Labeling Recommendations to Improve Patient Communication: Draft Guidance for Industry and Food and Drug Administration Staff. FDA. Published October 23, 2019. https://bit.ly/33V42z1. Accessed October 25, 2019.

Following concerns over breast implant-associated cancer and illnesses, the Food and Drug Administration issued draft guidelines for additional labeling measures on devices.
 

FDA Recommends New Labeling Guidelines For Breast Implants

Nursing involves truly unique stressors, that if left unmanaged, can lead to equally unique negative outcomes. These include Burnout (A state of physical, emotional, and mental exhaustion caused by a depletion of the ability to cope with one’s environment, particularly the work environment)

 and Compassion Fatigue (Physical, emotional, and spiritual exhaustion resulting from caring for patients and witnessing pain and suffering).

 The principles of Stress Management are the same regardless of one’s job but can provide a very helpful framework for nurses to decrease job stress and improve health outcomes for themselves and their patients 

Stress Awareness involves identifying one’s personal 

 of stress (stressors) as well as identifying one’s personal 

 to stress.  There are six work domains relevant to a nurses’ stress levels. 

 involves the amount of work required, the frequency of unexpected events and the suffering acuity of patients.

refers to participation in work decisions, quality of management leadership, and patient outcomes.

 describes recognition for achievements as well as opportunities for bonuses and raises.

 includes the frequency of supportive work interactions and the closeness of personal friendships at work.

 refers to the administration’s dedication to equal consideration for everyone and clear procedures for allocating rewards and promotions.

involve the confidence that one’s personal and organizational mission is meaningful and that there is the potential to contribute to the greater good.

Nurses can go through these domains to identify their own stressors and think about how they are reacting physiologically (e.g., headaches), psychologically (e.g., anxiety or depression), and behaviorally (e.g., missing work, or getting angry with colleagues).

Once aware, one can recognize when suffering from stress and can begin to implement a number of practical management techniques. First, try to eliminate or modify the severity of the stressor via problem-solving.  Relax and focus on nothing but the issue at hand. Identify the real problem.  Brainstorm for possible solutions. Select one possible solution and implement it. If it works, celebrate! If it not, go back to brainstorming and trying different solutions.

The six nursing work domains can be a framework for brainstorming ideas. Talk with co-workers to see who may have some of the same concerns and think of ways to make changes among yourselves. Then, approach the administration as a group to ask for help with larger issues, which can also enhance the credibility of the problem if a number of your colleagues echo the same issues.

Next, one can try changing one’s attitude toward or cognitive appraisal of the stressor.  There are a number of ways to do this that are quite relevant to nurses. First, a nurse must be clear about the scope of their professional role.  A nurse cannot always cure a patient’s illness or disease or solve all problems, however, a nurse can always do 

 to make a patient, family member, caregiver and/or colleague feel better. A nurse must be absolutely, positively convinced about the incredible value of every nursing intervention performed!

Hope related to health status is a prime example of how nurses can change their cognitive appraisal. There is no such thing as “false hope.” However, what is hoped for, probably will change over time. What is first hoped for in the face of illness or disease is cure or return to full physical and mental health. What is next hoped for is a positive adaptation to partial physical and/or mental health with a good quality of life. This can be a long trajectory with diminishing yet important and valuable hopes.  What is finally hoped for is an end of life with all instrumental and emotional business completed in a dignified, pain-free manner, and in the presence of people who care/matter.

Fears and perceptions about the End of Life, both for oneself and one’s patients, are major stressors for nurses. First, our fears about the process of dying that include loss of dignity, pain, and sadness about leaving loved ones. Palliative and Hospice Care are major resources that can significantly mitigate these issues. Next, are fears about being dead. One way to cognitively approach this is the “Two Option Plan.” Option 1 is that there is an Afterlife/Heaven. Most references describe this as beautiful, peaceful, and joyful. There is no pain, suffering, or sadness. The deceased will join ones who have died earlier and in a blink of celestial time, loved ones left behind will also arrive. Option 2 is there is no Afterlife, everything just ends, there is nothing. However, there is no pain, suffering, or sadness. There is no consciousness at all.  This is akin to the best night’s sleep one ever had, one just doesn’t wake up. The bottom line is that this is not bad! Everyone has their own personal beliefs about what comes next, and it’s important to not only be conscious of your own but also your patient’s.

The final stress management technique is learning how to change one’s physiological reaction to a stressor from negative to positive by shutting off the chronic release of stress hormones and turning on positive neuro-endocrine-Immune responses such as endogenous opioids. These are naturally occurring opiate-like substances and are pain killers. They are also anti-depressants and enhance the immune system. Fortunately, there are a number of mechanisms that serve both functions. These include exercise, laughter, music (listening to, singing, playing), pets, aromatherapy, meditation, and much more. Allowing you a wide variety of options to find the best technique that fits you.

Stress and its management, particularly for nurses, are complex issues but ones that can be successfully managed. For more information on Stress Management go to 

1. Maslach C. (1982) Burnout-The cost of caring. Englewood Cliffs, NJ;Spectrum.

2. Aycock, N, Boyle, D. (2009) Interventions to manage compassion fatigue in oncology nursing 

3. Fawzy FI, Fawzy NW, Pasnau RO. (1991) Burnout in the health professions.  In Judd, Burrows, Lipsitt (eds.), 

Handbook of Studies on General Hospital Psychiatry

, Elsevier Science Publishers B.V.:New York, 119-130.

4. Figley, CR. Treating compassion fatigue. New York,NY: Brunner-Routledge

5. Henry BJ. (2014) Nursing burnout interventions: What is being done? 

6. Houck, D. (2014) Helping nurses cope with grief and compassion fatigue: An educational intervention. 

Stress management is vital for any profession, but for oncology nurses, stress management is crucial to not only helping themselves but also helping their patients.

Stress Management for Nurses

As cancer survival rates increase, healthcare professionals may be treating more patients who are considered long-term survivors (5 years or more after treatment). The 5-year survival milestone is often a cause for celebration, but results from studies show that 20% to 30% of long-term survivors continue to have needs that nurses and other members of their healthcare team can address, at least in part.

Survivorship comes with its own set of physical, emotional, and financial challenges. To promote good quality of life and autonomy, long-term survivors will need ongoing support. Healthcare teams can provide this by implementing survivorship care plans, using telemedicine, or bringing on more support staff, such as patient navigators.

Even 5 years or more after treatment, patients can continue to experience the physical effects of cancer treatment, which may affect their ability to perform typical daily activities. These effects can include pain, neuropathy, sexual dysfunction, incontinence, and fatigue, among others. Some treatments lead to other health risks, such as damage to the heart, bones, or other organs, as well as an increased risk for other cancers.

For patients with cancer, their journey does not end after treatment is over.

Supportive Care