As the cancer treatment landscape continues to evolve, the role of front-line nurses in clinical trials remains essential, according to Anne Delengowski, RN, MSN, AOCN, CCCTM.

“I don’t know if nurses today can truly appreciate where we’ve come because they were never there, [but] I have had the honor and privilege of being there,” Delengowski, who has been an oncology nurse for 42 years, and is the director of Oncology Nursing Education at Thomas Jefferson University Hospital, said in an interview. “In the past, we had very few cancer drugs, we had minimal second-line therapies which are standard now, we didn’t have targeted therapy or immunotherapy, and we had poor symptom management.” 

Delengowski recently presented at the 2022 Oncology Nursing Society Bridge, highlighting notable improvements spanning the course of her career and the excitement that comes with being a part of a clinical trial from start to finish. In a post-presentation interview with 

®, Delengowski offered a personal perspective into how the field has changed during her career as a frontline nurse.

“When I first started as a cancer nurse, we didn’t have the antiemetics we have today, and it was awful. I did a study back then with a colleague from the school of nursing looking at anticipatory nausea and vomiting because the patients would come in vomiting prior to getting their drugs because they were anticipating it happening, [but] very rarely do you see that anymore. We [also] didn’t have growth factors; we didn’t have the colony stimulators to be able to prevent neutropenic fevers, so patients were hospitalized for most of the course of their disease. Today, all the stuff we talked about here came through clinical trials.”

She also highlighted how pain management strategies have significantly improved.

“I worked a lot in nightshift when I was in graduate school, and we didn’t have sustained release narcotics,” she said. “We used to have to wake people up in the middle of the night to give them pain medicine because if we didn’t their pain would be out of control in the morning. Once again, it was revolutionized that we have PCA [patient-controlled analgesia] pumps now, we have sustained release therapy. The nightmare of seeing patients in pain, you kind of weighed the fact if I didn’t wake them up, they’d be in a lot of pain in the morning and if I did wake them up, I interrupted their sleep, and it wasn’t good.”

Throughout her career, she shared that she has been inspired by the advances that clinical trials have brought about. She noted that patients are living longer, healthier lives, and that clinical trials are allowing providers to achieve “magical things.”

She noted, as an example, the breakthrough findings from Memorial Sloan Kettering Cancer Center where 100% of patients with rectal mismatch repair-deficient locally advanced rectal cancer achieved a complete response with dostarlimab-gxly (Jemperli).

Delengowski shared that, prior to working in clinical trials, she did not understand much about the process or have proper understanding or the extent of the behind-the-scenes work. For example, in her presentation, she explained how clinical trials must receive approval form a multidisciplinary disease group and a facilitation committee, along with a protocol review committee. In addition, there is a site initiation visit which provides the principal investigator and the team with training on all aspects of the trial, prior to its initiation.

Teamwork is also critical and research coordinators who understand the trial have been involved from the inception to guide nurses.

As part of her presentation, Delengowski outlined the different phases of clinical trials. Phase 1 trials are specifically designed to find a safe dose of a novel regimen for humans. This step determines how much a new treatment should be given (ie, oral or intravenous administration), and what the maximum-tolerated dose is.

Delengowski stressed, “A lot of times in phase 1 [trials] we don’t know what the symptoms or outcomes might be, so we need to be cognizant of the fact that anything that happens to that patient we need to document. We need to make sure we do it and we need to follow the protocol to dot the i, cross the t and do it all perfectly because if everyone chooses to do something different than it really doesn't make the trial valuable.”

“I remember giving my very first phase 1 [treatment] and I took a step back thinking ‘You want me to give this to a human being now? It’s the first time a human being has received this drug,’” she said. “I was humbled and wowed at the same time. It was wonderful for all involved, but a little frightening it was for us [as nurses] to administer.”

Phase 2 trials are larger and are designed to determine if the new treatment is effective against a certain cancer, as well as its safety profile. Phase 3 trials compare the new treatment (or new use of a treatment) against the current standard of care.

Across the trial continuum, supporting patients during the trial remains a significant part of the nurse’s role as patients can be overwhelmed throughout treatment. Delengowski highlighted that knowing where to get information for patients and helping to educate them is important for front-line nurses.

“It becomes very exciting when you know you’re part of [clinical trials],” she said. “Some frontline nurses may not exactly understand the value they bring, but [they’re] invaluable; We’re the frontline, we’re the last line, we’re the point where the person gets the medication or the therapy.”

However, phase 3 trials, which are usually randomized, can be difficult for nurses, because patients may not be happy to learn they were randomly assigned to receive the standard of care.

Delengowski explained “It's very hard when you talk up a study and the patient was randomized to standard of care. Often a frontline nurse will be confronted with [patients who say] ‘I signed on thinking I was going to get the new therapy and now I got standard of care drug.’ ”

“What I tell [patients] is in phase 3 studies we don’t know that standard care might be the best therapy. We don’t know and that’s what this is all about. I’ve been involved in phase 3 [trials], where the [experimental drug] was not better than standard of care; it was good, but not as good. It’s just part of the process and once you give that information to the patient, they feel a bit better about it.”

When looking back on all the various phases of clinical trials she has been a part of, Delengowski said it was an exciting feeling to think, “Wow, I was part of that, and we were there when it happened. Some of the trials didn’t come to fruition, but a lot of them did and when you look at that and know that you were part of it, it is so exciting…. As cancer nurses we see the patient go through from diagnosis to hopefully a long life, but in between there’s roadblocks. If they fail first-line therapy and other therapies and go onto a clinical trial, we walk that walk with them. I think that understanding that there is that next step [is important].”

Future steps in improving the clinical trial process include ensuring that inclusivity is a priority and that trials will be brought to the community. Historically, clinical trials have been performed in large academic centers which can be difficult to get to and exploring ways to bring them to patients and working with a community-based staff can be beneficial in making the clinical trials more comfortable for patients.

“[Clinical trials] give that glimmer of hope to someone that there may be other outcomes out there,” Delengowski said. “Even if it’s not something that’s going to be beneficial for that individual, which is not always the case, but it leads to phase 2 and phase 3 [trials] where there seemingly is some hope for a disease process that might not have had a whole lot of other options.”

Delengowski A. Clinical trials on the frontline: the changing landscape of clinical trials nursing. Presented at: ONS Bridge; September 13-15, 2022; virtual.

Cercek A, Lumish MA, Sinopoli JC, et al. Single agent PD-1 blockade as curative-intent treatment in mismatch repair deficient locally advanced rectal cancer. 

. 2022;40(suppl 17):LBA5. doi:10.1200/JCO.2022.40.17_suppl.LBA5

Articles

Anne Delengowski, RN, MSN, AOCN, CCCTM, discusses the evolving role of the oncology nurse in clinical trial research.

Clinical Trials Continue to Propel Field of Oncology with Nurses on The Frontline

Elacestrant (RAD-1901), an oral selective estrogen receptor degrader (SERD), significantly prolonged progression-free survival (PFS) in pretreated patients with endocrine receptor (ER)-positive, HER2-negative advanced breast cancer, representing an oral contender to current standard-of-care (SOC) endocrine therapy options in this patient population. Moreover, the benefit was observed in both the total population and a subset of patients with 

-mutated disease, according to findings published in the 

Data from the phase 3 EMERALD trial (NCT03778931) demonstrated that PFS was prolonged in all patients (HR, 0.70; 95% CI, 0.55-0.88; 

 = .002), as well as in patients harboring an 

= .005). In addition, cardiac and ocular toxicities, which have been reported with other SERDs, were not observed on this study.

Furthermore, the elacestrant had a promising safety profile; grade 3/4 treatment-related adverse events (TRAEs) were reported in 7.2% of patients receiving elacestrant and 3.1% of those receiving the standard of care regimen. Nausea, the most prominent any grade TRAEs to be observed, occurred in 35.0% and 18.8% of patients within the 2 arms, respectively.

“Elacestrant showed a predictable and manageable safety profile consistent with other endocrine therapies,” wrote Francois-Clément Bidard, MD, PhD,, professor of medicine and medical oncology at Institut Curie in the study. “These data represent a long-awaited opportunity to potentially offer second- or third line, including heavily pretreated, patients with breast cancer a new effective option and further advance toward precision medicine in the ER-positive/HER2-negative subtype.”

Authors also acknowledged that the efficacy of elacestrant in this setting is exciting, because the agent represents an oral alternative to intramuscular fulvestrant (Faslodex) injections.

Recommended first-line SOC for locally advanced or metastatic ER-positive, HER2-negative breast cancer is endocrine therapy, either with an aromatase inhibitor (AI) or fulvestrant, and a CDK4/6 inhibitor. Sequential therapies may be necessary if a patient’s disease demonstrates endocrine resistance, which involves the development of acquired mutations in a variety of genes such as 

Although guidelines advise sequential endocrine therapies, the clinical activity of endocrine monotherapy for these patients is limited, and the median PFS for patients with prior treatment with CDK4/6 or mTOR inhibitors is 2 months—underscoring a significant unmet clinical need.

Elacestrant is a novel, nonsteroidal, oral SERD which has elicited promising antitumor activity and tolerability in phase 1 trials with heavily pretreated patients. To that end, investigators designed an international, multicenter, open-label, phase 3 trial to pit the agent against SOC endocrine therapy.

Between February 2019 and October 2020, 477 patients were randomly assigned to receive either elacestrant (n = 239) or SOC therapy (n = 238). To enroll, patients needed a histologically or cytologically proven ER-positive, HER2-negative breast adenocarcinoma, and locoregionally recurrent or metastatic disease. They also needed demonstrated disease progression following 1 to 2 lines of endocrine therapy. Previous treatment with CDK4/6 inhibition, in combination with an AI or fulvestrant was required.Most enrolled patients had visceral metastasis in both arms (68.2% and 71% in the 2 arms, respectively).

 status, visceral metastases, and previous fulvestrant treatment. Patients who received elacestrant did so at a dose of 400 mg daily. In the event of toxicity, reduction to 300 mg or 200 mg daily were permitted. Investigators could choose between fulvestrant, anastrozole, letrozole, or exemestane monotherapy for SOC endocrine therapy.

PFS was the primary end point for the trial. Key secondary end points included overall survival (OS) in all populations, as well as objective response rate, duration of response, and clinical benefit rate, and safety and tolerability.

The 6-month PFS rate was 34.3% (95% CI, 27.2%-41.5%) with elacestrant and 20.4% (95% CI, 14.1%-26.7%) with the SOC. Among patients with an 

mutation, the rates were 40.8% (95% CI, 30.1%-51.4%), respectively. Moreover, the 12-month PFS rates in the all-patient population was 22.3% (95% CI, 15.2%-29.4%) vs 9.4% (95% CI, 4.0%-14.8%), respectively. In the 

-mutated population, the 12-month PFS rate was 26.8% (95% CI, 16.2%-37.4%) vs 8.2% (95% CI, 1.3%-15.1%), respectively.

In terms of OS, at an interim analysis, 149 events had occurred in all patients, with a hazard ratio of 0.75 (95% CI, 0.54-1.04; 

-mutated population, there were a total of 68 events (HR, 0.59; 95% CI, 0.36-0.96; 

Overall, 218 patients receiving elacestrant (92.0%) and 197 patients receiving SOC (86.0%) experienced an any-grade adverse event (AE). In both arms, the most common toxicities were nausea (35.0% vs 18.8%), fatigue (19.0% vs 18.8%), vomiting (19.0% vs 8.3%), decreased appetite (14.8% vs 9.2%), and arthralgia (14.3% vs 16.2%). For grade 3/4 AEs, the most common toxicities with elacestrant included nausea, back pain, and increased ALT; nausea, fatigue, diarrhea, and increased AST were most prevalent in the SOC arm.

AEs were responsible for treatment discontinuation in 15 patients in the experimental and 10 patients in the control. No treatment-related deaths were reported in either cohort.

Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD trial. 

. 2022;40(28):3246-3256. doi:10.1200/JCO.22.00338

Elacestrant, an oral selective estrogen receptor degrader, may hold the potential to replace intramuscular fulvestrant injections for patients with endocrine receptor–positive, HER2-negative breast cancer. 

Oral SERD Elacestrant Shows Significant PFS Improvement in ER+/HER2– Advanced Breast Cancer

Videos

Comprehensive insight on the optimal management of diarrhea associated with ADC therapy, with regard to patient education and monitoring during treatment.

T-DXd in HER2+ Gastric Cancer: Educating Patients About Risk of Diarrhea

Panelists share their perspective on the role of the broader, multidisciplinary healthcare team in managing toxicity associated with trastuzumab deruxtecan therapy.

Role of the Broader Healthcare Team in Managing AEs Associated With T-DXd 

October is Breast Cancer Awareness month. This disease is relentless and again back in the news. This past week, TV journalist Katie Couric, revealed she had received a diagnosis of breast cancer in June. Couric, age 65, has been treated with radiation and a lumpectomy. She had her mammogram taped in real time to raise awareness about screening just as she had done to raise awareness with her colonoscopyafter her first husband died from colon cancer in his forties.

Breast cancer awareness has been in the media spotlight for many years now. At hospitals across the country, RNs and social workers wear pink to raise awareness of this cause. Branding is powerful. AIDS related causes use red, and organ donation goes with green. I was curious as to why breast cancer related causes had a pink theme. As ironic as it seems, this was not a Madison Avenue campaign from New York.

This was the brainchild of Charlotte Haley from Simi Valley California in 1991. Charlotte Haley was not in the public relations business. Her goal was to simply create some attention around breast cancer. At age 68, 3 of her close family members had gone through the battle with breast cancer. She began raising awareness in the grocery store by handing out postcards with 5 peach ribbons. Interestingly, by many accounts, peach was the first color recognized for breast cancer awareness. Peach eventually evolved into pink.

The postcards that Charlotte Haley handed out explained that only 5% of the National Cancer Institute’s annual budget out of $1.8 billion was earmarked to prevent cancer in general.

 The ribbon was supposed to create attention and it did; both through word-of-mouth and though catching the attention of major newspapers. Before Instagram, Tik Tok, and brand influencers, newspapers created a firestorm around causes. As Haley was handing out ribbons in 1991, by 1992, the 

 had dubbed the year as “The Year of the Ribbon,” on account of other ribbons gaining attention, such as the yellow ribbons associated with the First Gulf War in 1991 and the red AIDs awareness ribbons from that same year.

However, the grassroots efforts of Haley gained national attention once Alexandra Penney, 

magazine editor and Estee Lauder of the cosmetics firm, became involved. Penney wanted to use Haley’s ribbons as part of her second annual “Breast Cancer Awareness Issue.” Haley was uninterested, she felt they were too corporate and commercialized. However, Penney’s legal counsel advised her that if they changed the ribbon to a different color, they did not need Haley’s permission. Breast cancer ribbons were born. The peach color was left behind.

Coincidentally, the Susan G. Komen for the Cure® Foundation has been affiliated with the color pink since its start in 1982, although they did not begin handing out pink ribbons until 1991. From the mid-1980s to the early 1990s, their brand design used a pink ribbon with a woman running. Since 1990, pink was the color used to identify breast cancer survivors. When women ran in the Komen Race for the Cure in New York, pink ribbons were given to all runners and disease survivors alike. Again, Alexandra Penney of 

wanted to get involved. Unlike Haley, the Susan G. Komen for the Cure® Foundation was interested in working with Penney. The result was a pink ribbon which Penney enlisted cosmetic companies to distribute throughout New York City stores.

Now, just like a stop sign is universally red, breast cancer awareness is universally pink. And although any generic pink ribbon can be used to represent breast cancer awareness, the Komen “running ribbon” is reserved solely for use by Susan G. Komen for the Cure®, the name the foundation officially adopted in 2007.

They also decided to create a new brand recognition item, that is, a new pink “running ribbon.”

As I read about Katie Couric, I wondered how many oncology nurses had heard of Charlotte Haley. I hope nurses in all specialties will honor her work and pay tribute to Couric’s advocacy by educating their patients about breast cancer risk and emphasizing the importance of early detection.

France Respers, L.Katie Couric reveals she was diagnosed with breast cancer. CNN. September 28, 2022. Accessed October 1, 2022. https://cnn.it/3CzhJId

Waxman, O. Wearing a pink ribbon for breast cancer awareness? Here’s how awareness ribbons became a thing. 

. October 1, 2018. Accessed October 1, 2022. https://bit.ly/3Cwgn0P

In memoriam: Charlotte Haley, creator of the first (peach) breast cancer ribbon. Breast Cancer Action Website. Accessed October 1, 2022. 

The pink ribbon story. Susan G. Komen for the Cure. Accessed October 1, 2022. 

By certain accounts, the breast cancer awareness ribbon was actually peach before it was pink. 

Opinion: Oncology Nurses Should Know the History of the Pink Breast Cancer Awareness Ribbon

I recently cared for a 32-year-old woman who was admitted to the Inpatient Oncology Unit 2 months after giving birth to her first child. She had been transferred to us for a higher level of care and was diagnosed with acute leukemia. The joy of having a baby quickly turned to insomnia, and she began having panic attacks about her disease as well as treatment-related nausea.

She also had a history of depression and suicidal behavior, which posed a significant challenge for her care team. Our attempts to manage the mental problems that were beginning to become manifest during her third week were unsuccessful. Eventually, the nursing staff started to feel that they had “failed” to “help her feel better” and no longer wanted to have her as a patient.

No patient assignment was conducive to caring for her and helping her cope. After many failed attempts, the woman requested alternative therapy for anxiety and insomnia and to cope with not being able to see her baby and was eventually prescribed medicinal cannabis.

Unfortunately, 30% of patients with cancer develop a mental disorder during the course of their illness.

 Those currently recognized in the literature include anxiety and mood disorders, which can have a negative impact on treatment, lead to suicidal ideation, and create additional difficulties for health care workers. Initially, the hospital stay can be prolonged.

But as time passes, patients may become dissatisfied and not adhere to treatment.

Diminished overall quality of life can lead to increased mortality.

Oncology nurses have also identified suicidal ideation as challenging to manage. Currently, there are no protocols they can follow in terms of who should be contacted, who should complete the documentation, and who should assess patients.

 Although nurses are trained to assess the psychosocial needs of patients, they need better resources to mitigate patient mental health problems.

Oncology nurses face a number of obstacles when addressing a patient’s mental health, including lack of training, increased workload, and lack of resources or access to resources.

 In addition, the stigma surrounding mental disorders continues to plague health care and to make patients hesitant to seek treatment.

Increased workloads significantly hinder a nurse’s ability to manage mental health disorders.

 The complexity of the care inpatients require doesn’t lend itself to prompt treatment escalation. Even when patients are coping badly, nurses may prioritize the care that is most urgently needed.

Moreover, the number of psychologists, psychiatrists, and social workers in hospitals is extremely limited. During the pandemic, many were working from home and triaged emergency cases to maximize safety.

Standardized mental health assessment tools are essential for nurses to recognize the problem early, and clear guidelines are needed to respond to a mental crisis once identified.

 Low-intensity cognitive therapy can be extremely effective, but nurses need to be taught how to deliver it.

Oncology nurses can also help reduce the stigma attached to mental health care, which not only prevents timely treatment but leads to seclusion.

 Nurses can work to increase awareness about how this stigma reduces quality of life.

Nurses are gatekeepers who can identify disorders early and triage patients. Although oncology nurses in particular are trained to show empathy and offer support, it is clear from the literature that they lack the competence to care for patients with acute mental health problems. It is equally clear that patients with such problems must be promptly identified and assessed by nurses who are trained and possess the correct guidelines.

Nakash O, Liphshitz I, Keinan-Boker L, Levav I. The effect of cancer on suicide among elderly Holocaust survivors. 

2013;43(3):290-295. doi:10.1111/sltb.12015

Prieto JM, Blanch J, Atala J, et al. Psychiatric morbidity and impact on hospital length of stay among hematologic cancer patients receiving stem-cell transplantation. 

 2002;20(7):1907-1917. doi:10.1200/JCO.2002.07.101

Bui QUT, Ostir GV, Kuo YF, Freeman J, Goodwin JS. Relationship of depression to patient satisfaction: findings from the barriers to breast cancer study

2005;89(1):23-28.doi:10.1007/s10549-004-1005-9

Adler NE, Page AEK, Institute of Medicine (US) Committee on Psychosocial Services to Cancer Patients/Families in a Community Setting, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. National Academies Press (US); 2008. 

https://pubmed.ncbi.nlm.nih.gov/20669419/

Granek L, Nakash O, Ariad S, Shapira S, Ben-David M. Mental health distress: oncology nurses’ strategies and barriers in identifying distress in patients with cancer. 

. 2019;23(1):43-51. doi:10.1188/19.CJON.43-51

Corrigan PW, Druss BG, Perlick DA. The impact of mental illness stigma on seeking and participating in mental health care. 

. 2014;15(2):37-70. doi:10.1177/1529100614531398

Although oncology nurses are trained to show empathy and offer support, they lack the resources to adequately care for patients with acute mental health problems. 

Oncology Nurses Need Better Resources to Help Patients With Mental Health Problems

® spoke with Milagros Elia, MA, APRN, ANP-BC, about the role that oncology nurses play in increasing dialogue around climate change. Elia recently presented on climate change as part of the 

. In this episode, she discusses how increases in heat and poor air quality can negatively affect vulnerable populations, and the role nurses play in proactively managing their patients’ health in the context of changing local climates.

Top takeaways from the discussion include:

“We know that climate change is damaging human health today and will have a greater impact in the future. These health consequences will inevitably harm some more than others.” 

“As nurses, we realize that extreme heat can take a toll on the body and increase the risk of heat-related illnesses and hospitalizations.” 

“How do we allow for the continuation of care when we have an area that has been flooded? Or [where] wildfires have been?” 

“[If] you have patients going undergoing chemotherapy, they are extra sensitive to the sun; they need extra [sun] protection, so you tell them about the EPA’s [Environment Protection Agency] UV index application.” 

“You don't need to use the word climate change with [your patients] unless they are open to that conversation. What you need to do is you need to address their symptoms and make the connection to their environment.” 

Episode 27: COVID-19 Pandemic Emphasizes Disparities in Cancer Care

Episode 10: The Year of the Nurses' Voice

Climate Change and Evolving Threats to Public Health: The Oncology Nurse’s Role

Better Research Funding Practices Are Needed to Mitigate Disparities in Cancer Incidence and Mortality

Sunscreen Guide Contains Surprises About Effectiveness

Oncology Nursing News® Publication Features

The Connection Between Lung Cancer and Outdoor Air Pollution

Expert Says Pandemic Put a ‘Lens’ on Health Disparities for People Outside the Medical Field

Climate change and health. World Health Organization. October 30, 2021. Accessed September 22, 2022. 

Elia MR. Climate change and its impact on health. Presented at: ONS Bridge; September 13-15, 2022; virtual.

Nogueira LM, Yabroff KR, Bernstein A. Climate change and cancer. 

. 2020;70(4):239-244. doi:10.3322/caac.21610

Walker RK, Pereira-Morales S, Kerr R, Schenk E. Climate change should be on every nursing research agenda. 

. 2020;47(2):135-144. doi:10.1188/20.ONF.135-144

Butterfield P, Leffers J, Vásquez MD. Nursing’s pivotal role in global climate action. 

 2021;14(373):n1049. doi:10.1136/bmj.n1049. PMCID: PMC8201521.

Man RX, Lack DA, Wyatt CE, Murray V. The effect of natural disasters on cancer care: a systematic review. 

. 2018;19(9):e482-e499. doi:10.1016/S1470-2045(18)30412-1

Turner MC, Andersen ZJ, Baccarelli A, et al. Outdoor air pollution and cancer: an overview of the current evidence and public health recommendations. 

. 2020;10.3322/caac.21632. doi:10.3322/caac.21632

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Podcasts

In this episode of The Vitals, Milagros Elia, MA, APRN, ANP-BC, highlights how oncology nurses play a role in ongoing conversations regarding the intersection of climate change and public health. 


Milagros Elia Underscores How Oncology Nursing and Climate Health Are Intertwined 

Panelists briefly review ongoing clinical trials with trastuzumab deruxtecan in the setting of HER2+ gastric cancers.

Ongoing Clinical Trials With T-DXd in HER2+ Gastric Cancer

Shifting focus to the second patient profile of HER2+ gastric cancer, key opinion leaders highlight the risk and management of diarrhea in this setting.

Patient Profile 4: A Patient with HER2+ Gastric Cancer Treated With T-DXd Who Develops Diarrhea 

The rise in popularity of oral anticancer therapy has introduced problems of access and insurance coverage that oncology nurses previously did not have to deal with, according to expert presenters at the 2022 Oncology Nurse Society Bridge. However, many resources are available to nurses, and a key first step is to ask patients how they are faring financially.

“Even though you might not have all the answers right then and there when you’re talking to the patient, don’t shy away from a discussion you can have [about] their finances,” said Mary Anderson, BSN, RN, OCN, an oral oncolytic nurse navigator at Norton Cancer Institute.

Anderson presented alongside Christina Bach, MBE, MSW, LCSW, OSW-C, FAOSW; and Nora Hansen, CPhT, in a presentation titled “Managing Oral Cancer Therapies: What Are Your Tools?” The team highlighted the scope of the problem of financial-related toxicities, best practices for financial toxicity assessment, and resources to help nurses connect their patients to the care they need. 

When assessing patients for the first time, oncology nurses are encouraged to ask the following questions:

Are you able to get to the pharmacy to pick up your medications?

Are you able to get medications delivered to your home?

Other key questions include asking the patient to describe their insurance coverage plan, to highlight any other expenses they are worried may arise during their cancer care (ie, transportation, parking, child care, loss of income), if they are concerned about job loss, if they have had difficulty getting a prescription in the past, if their out-of-pocket expenses are what they expected, and if they are worried about financial toxicity affecting their quality of life.

“I start with making sure that folks understand that I’m not trying to be intrusive or overstep my bounds in asking really personal and private questions that we just don’t [normally talk about],” Anderson said. “I always say; ‘I know this is personal. I know a lot of people don’t want to talk about it. But knowing this information, is going to help me help you. And this is all between the two of us.’”

“We are validating that this is uncomfortable,” she added. “We’re also validating that it’s hard to ask for help—and also giving them permission at any time to say, ‘You know what, I don't want to answer that question.’”

Unfortunately, medical debt represents the number 1 cause of personal bankruptcy in the United States.

 Since 2010, cancer care spending has increased by approximately $175 billion. It is expected to continue to grow and reach $246 billion by 2030.

 Moreover, the average out of pocket expenses per patient increased from $1800 to $2900 per month since 2010.

“We have a major crisis when it comes to medical debt in this country,” Bach, an oncology social worker with OncoLink added. “A lot of that has to do with the way cancer [treatment] has changed a great deal in terms of oral oncolytics.”

“What is available to patients and how they access them is quite different than it was when I started as an oncology social worker in 2000,” she added. “[In 2000,] almost [every patient] was admitted for all their treatment for multiple days, it was covered by their major medical [insurance], and there were very few oral medications available.”

Presenters noted that solutions to help patients are also unfortunately limited: assistance from co-pay foundations are limited to certain diseases, procedures, and availability. In private practice oncology settings, which are often the only geographical option available to patients, charity care is not usually offered.

In addition, the Unites States has historically not regulated drug prices or had a system for drug price negation and a diagnosis of cancer does not equate to automatic approval for disability. Paid family leave varies across states but is generally limited—meaning that job loss (and consequent health insurance loss) is a reality faced by many Americans with cancer.

“Our solutions are limited,” Bach said. “I often feel like my hands are tied. It is very frustrating and also very morally distressing.”

Because of these increasing costs, it is not uncommon for patients to delay or forego treatments because of their financial burden. However, it is documented in the literature that financial toxicity is often linked to poorer outcomes.

Financial hardships often also extend into survivorship; 54% of survivors are between the ages of 18 and 64 years, 42% of whom reported experiencing financial hardships following diagnosis. Debt is most prevalent in populations under the age of 64 years, as well as in Black communities.

Previously, the problem in the United States was that most patients were uninsured. However, in 2022, the problem has become that patients are underinsured.

The speakers noted that it can be difficult for patients and nurses alike to understand the difference between Medicare A, B, and D. They outlined the general difference between plans as part of their presentation:

Medicare Part A is hospital insurance and is often premium-free;

Medicare part B is outpatient medical, and patients must opt in and pay a monthly premium;

Medicare part D is voluntary prescription drug coverage, patient pays premium and co-insurance (deductible and up to 25%);

Medicare part C is known as the “advantage plan;” it is offered by private insurance plans that contract with Medicare, it covers the same services as Medicare A, B, and some drug coverages, and patients choose their provider and plan, such as HMO;

Patients may also have Medicare supplements, which is optional additional coverage for co-insurance and deductibles. 

Insured patients are responsible for paying a premium, a deductible, the copay, the co-insurance, but may be unaware of additional items that are not covered. These may include cancer related needs or services, such as wigs, supplements, lymphedema garments, some durable medical equipment, private duty assistance, and indirect costs, including transportation, parking, child/elder care, loss of income/wages, and caregiving. This represents a heavy financial burden for many, speakers agreed.

The recently approved Inflation Reduction Act is expected to help ease some of the financial toxicity that patients face by capping the amount that a patient is expected to pay per year and lowering premium prices.

 Moreover, the act introduced the concept of price drug negations the consequences of which could be monumental for patients, according to Bach. However, despite the act’s approval, many of the benefits are many years away.

In the meantime, nurses should know that although they play a crucial role in helping connect patients to the resources they need, they are part of a team of players who can help patients navigate the world of insurance. Other professionals who can be leveraged include private brokers, social workers, financial navigators/advocates, state health insurance assistance programs (SHIAPS) counselors, ACA navigation assistance, private brokers. Because there are so many people invested in helping connect patients to help, nurses should not feel alone or intimidated to bring up the conversation: they are not expected to solve the problem, but they can help improve the situation.

The experts also recommend that oncology nurses leverage online resources, such as, 

ONS Guidelines™ to Support Patient Adherence to Oral Anticancer Medications

Cancer Support Community Financial Navigation

Gordon D. 50% of Americans now carry medical debt; a new chronic condition for millions. Forbes. October 13, 2021. Accessed September 26, 2022. 

Abrams HR, Durbin S, Huang CX, et al. Financial toxicity in cancer care: origins, impact, and solutions. 

. 2021;11(11):2043-2054. doi:10.1093/tbm/ibab091

Yabroff KR, Han X, Song W, et al. Association of medical financial hardship and mortality among cancer survivors in the United States. 

. 2022;114(6):863-870. doi:10.1093/jnci/djac044

Fact sheet: the Inflation Reduction Act supports workers and families. News release. The White House. August 19, 2022. Accessed September 26, 2022. 

Mary Anderson, BSN, RN, OCN; and Christina Bach, MBE, MSW, LCSW, OSW-C, FAOSW, discuss approaches to help patients navigate financial toxicity and insurance coverage in the age of oral anticancer drugs. 

Breast Cancer