Fatal and serious skin reactions have been reported with bendamustine hydrochloride injection treatment in clinical trials and postmarketing safety reports, including the toxic skin reactions Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and rash.

Skin reaction events occurred when bendamustine hydrochloride injection was given as a single agent and in combination with other anticancer agents or allopurinol.

Fatal and serious cases of liver injury have been reported with bendamustine hydrochloride injection. Combination therapy, progressive disease or reactivation of hepatitis B were confounding factors in some patients.

Most cases of hepatoxicity were reported within the first 3 months of starting therapy.

Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity.

Niolotinib is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.

Patients should be advised that treatment with nilotinib can cause serious thrombocytopenia, neutropenia, and anemia; possibly life-threatening, abnormal heartbeat; an increased risk of pancreatitits, tumor lysis syndrome; and fluid retention.

Patients should be cautioned about symptoms suggestive of these adverse events and advised to seek immediate medical attention if such symptoms occur.

The potential for serious adverse reactions in nursing infants whose mothers are being treated with nilotinib is unknown. Because many drugs are excreted in human milk, physicians should decide whether to advise nursing mothers to discontinue nursing or stop nilotinib treatment based on the importance of the drug to the mother.

Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy.

Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioids prior to, during, and for 2 hours following completion of dinutuximab infusion.

Permanently discontinue dinutuximab in patients with peripheral motor neuropathy of grade 2 or greater severity.

Urinary retention that persists for weeks to months following discontinuation of opioids has occurred in patients treated with dinutuximab; permanently discontinue the drug if retention does not resolve after opioid therapy ends.

Transverse myelitis and reversible posterior leukoencephalopathy syndrome (RPLS) have occurred in patients treated with dinutuximab. Permanently discontinue dinutuximab in patients who develop transverse myelitis and in patients with signs and symptoms of RPLS, such as severe headache, hypertension, visual changes, lethargy, or seizures.

FDA’s Drug Safety Labeling Changes database

Articles

Adverse Events Report

The adverse events report featuring FDA labeling changes for bendamustine hydrochloride, nilotinib, dinutuximab.

April Adverse Events Report: FDA Labeling Changes

When active cancer treatment finishes, some well-meaning people still believe that these survivors should celebrate and simply move on. Yet more often than not, the end of cancer treatment ushers in a host of new challenges, as survivors worry over recurrence, physical impairments, job lock, finances, and merely learning how to reconnect with family, friends, and coworkers after being singularly focused on just putting one foot in front of the other while navigating their journey from diagnosis through treatment.

Oncology nurses are well aware of this reality, says survivorship nurse navigator Darcy Burbage, RN, MSN, AOCN, CBCN, but providing care to the nation’s survivors, who currently number 15.5 million, “is really everyone’s business.” Burbage, who has been an oncology nurse her entire career, was drawn to survivorship care after being inspired by the resilience she observed in her patients with breast cancer as they embraced the “new normal” of life after treatment.

And despite the uncertainty surrounding what, at the time, was expected to be a 1-year position to launch a survivorship program at the institution—the Helen F. Graham Cancer Center & Research Institute in Wilmington, Delaware&mdash;where she works, Burbage jumped at the opportunity. Now, more than 6 years later, she&mdash;and the program&mdash;are still going strong.

Quickly immersing herself in shaping the young program, Burbage soon discovered that, “There is not a one-size-fits-all program for survivorship ... We’re in a community cancer center, so our program looks much different than an academic one.” Each survivorship care program needs to be tailored to meet the needs of the populations it serves.

Burbage’s practice is embedded in the cancer center’s radiation oncology department, so she sees patients as they prepare to finish their radiotherapy, as well as patients referred to her by physicians and nurses with the independent medical and surgical oncology practices based at her institution. And, “Sometimes the patients just find me.”

By 2026, there will be an estimated 20 million cancer survivors in the United States.

She added that because she is the only provider at her cancer center focused solely on survivor care, she must focus first on patients who need intense services. To triage these patients, she uses the Patient Health Questionnaire (PHQ-4) to gauge psychological distress. During visits with those patients, she provides education on long-term and late treatment effects, conducts follow-up on psychosocial issues prevalent in survivors using the 11-item version of the City of Hope Quality of Life scale, and provides them with a survivorship care plan (SCP). Many good options exist for building SCPs, Burbage said, but she particularly likes the Journey Forward template that can be downloaded and customized to meet individual survivor needs; it also automatically updates as new information becomes available.

Typically, within 3 months of treatment completion, she sits down with the patient to review the personalized SCP and provides 2 copies; she advises that 1 stay in the patient's personal medical file and the other is for their primary care provider (PCP). However, she also faxes it to the patient’s PCP to make sure the SCP is received and doesn’t end up at the bottom of a pile of papers.

“I urge patients to advocate for themselves, and they need to have this plan at hand so it can be part of their conversation,” Burbage continued.

When she meets a patient for the first time, she wants that person to guide the discussion. “I say, ‘I have access to your chart, but I want to hear your story,’” Burbage explained. Then she follows with an assessment tool, including a quality-of-life survey, and asks the patient to prioritize his or her top 3 concerns.

“It’s a journey. Sometimes it’s 1 or 2 visits, sometimes it’s many more,” said Burbage. Above all, “it’s patient-driven and determined by what they need. Patients want to stay connected with their healthcare team.”

Adding another complexity to the landscape of survivor care is that health issues often arise long after cancer treatment ends, and, observed Burbage, “It’s hard to identify a cause and effect a lot of time.” 

“Perhaps they received doxorubicin for their breast cancer in their 40s, and now they’re in their 60s. Are they going to recall that it was 20 years ago? Did people tell them about the cardiotoxicities? Even if they’re seeing the same PCP—and many are not&mdash;is the PCP going to relate it to their treatment? Or would they think it’s related to normal effects of aging or family history?”

All this points to the importance of education, said Burbage, and not just for survivors and oncology practitioners, but for PCPs, too: What are the late effects survivors need to look out for? What symptoms and signs they should be telling us about? Burbage added that because cancer, for some, has become a chronic disease and many people are living with advanced disease or on adjuvant treatment for early-stage cancers, comprehensive survivor care calls for both a multi-and interdisciplinary focus.

The Patients Health Questionnaire (PHQ-4)

NCCN Distress Thermometer and Problem List for Patients

Quality of Life Patient/Survivor Version (QOL-CSV)

Though cancer treatment has come a long way, survivors are likely to experience fear of recurrence. Burbage learned how big an issue this is for survivors when she started her career in nursing.

“I admit I was naïve. I would say, ‘You’ve finished treatment. How are you doing?’” thinking that was the end of the conversation,” Burbage recalled. She said she quickly realized there was much more to the conversation, and now, she just raises the topic: “I know you’re happy to be done, but a lot of people have concerns about how having cancer affects their relationships, returning to work, and/or they’re afraid it’s going to come back. How are you managing?”

“When I put it out there, people are so relieved—they just open up to you. Their families are excited they’re ‘done,’ having walked through this journey with them, but they really don’t know what it’s like, to come back for the follow-up exams and have that anxiety,” Burbage said.

As survivors get farther out from their active treatment, the cancer will not be at the forefront of their mind, “but it’s always going to be somewhere,” said Burbage, and she sees part of her role as providing the reassurance that help is out there if and when they need it. "We'll always be there," she assures patients. "We're not kicking you out to the curb—whether it's 2 weeks, 2 months, or 2 years."

In addition, although many treatment-related physical issues will improve over time, fear of recurrence is not the only psychosocial issue facing survivors, and Burbage would like to see more attention paid to these (Box). “There are a lot of issues survivors are dealing with right after treatment and beyond.”

The volume of survivors alone underscores the need for survivorship care. In its 4th annual “State of Cancer Care” report, the American Society of Clinical Oncology estimated that the number of cancer survivors is expected to grow by one-third over the next decade—from 15.5 million in 2016 to 20.3 million by 2026. Although there is no charge for the services Burbage provides, when survivors come back for other needed services that can be coded and charged, such as dietician or rehabilitation services, there are revenue opportunities for hospitals downstream.

• Fear of passing cancer on to their children

In fact, a key to the success of the survivorship program at her cancer center is buy-in from the top. “Our senior management staff really believes in the program,” said Burbage. Another critical driver for survivorship care is the Commission on Cancer’s Survivorship Care Plan Standard 3.3 requiring that patients who have completed active therapy receive a SCP, she added.

Ultimately, however, “Survivorship is about much more than that piece of paper," Burbage stresses. "It’s the conversation.”

Cover Story

The ever-growing number of cancer survivors means that practitioners across the healthcare spectrum need to step up to an active and dynamic role in their care.

Everyone's Business: Taking Survivorship Care to the Next Level

Janice Withycombe and Kate A. Yeager are assistant professors at the Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.

Significant progress has occurred in cancer treatment which has resulted in improved survival rates, but treatment toxicities are often a byproduct of therapy and these toxicities can negatively impact quality of life.

For patients enrolled in oncology clinical trials, mandatory reporting of adverse events (AEs) during cancer therapy is required by the federal government. 

The Common Terminology Criteria for Adverse Events

) is the reference book used by clinicians to complete this mandated AE reporting; however, up to one-third of the items in the 

 manual have some subjective component and are therefore best reported by patients. For this reason, it is imperative that the voice of the patient be captured, so that the full impact of treatment toxicity and symptoms is understood.

Patient reported outcomes (PROs) are defined as data reported directly from patients without interpretation from others. PROs produce useful metrics, which inherently provide more accurate data for subjective symptoms compared with clinician reporting. In fact, the more subjective the symptom, the lower the clinician—patient agreement of ratings of presence, frequency, and severity.

 For these reasons, the medical community has embraced, for over 2 decades, the fact that the most valid measure of a patient’s pain is the patient’s self-report of pain.

Nonetheless, investigators on clinical trials and clinical projects have been slow to adopt PRO metrics for other symptoms that are predominantly subjective (eg, cognitive problems, fatigue). PROs provide essential information for the assessment of the value of treatments, such as independent prognostication of survival across cancer sites

 and issues related to patient treatment adherence.

When patients refuse to take a medication as prescribed due to treatment-related symptoms, there is no value of that drug to the patient. The need for standard inclusion of PRO measures becomes even more pressing as we move forward with clinical trials of precision medicines, many of which include oral medications with multiple side effects that patients manage at home.

The National Cancer Institute (NCI) has been an international leader in providing metrics for toxicity and symptom assessments in clinical research, beginning with the 

 The NCI also supported the recent development and validation of the patient-reported version of the 

A core set of 12 symptoms—specifically, fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea&mdash;were included in the final recommendation for inclusion in clinical trials where a PRO is measured.

 should be used and reported in conjunction with the 

 reports gathered by clinicians. This patient data provides additional information that is complementary to existing safety and tolerability assessments reported by clinicians using the 

 items is dependent upon anticipated AEs based upon previous preclinical data and regimen-specific information.

Research has shown that children are also able to selfreport their symptoms during cancer therapy. The creation and validation of pediatric-specific PRO instruments requires careful consideration for the developmental stage of the child as well as emerging literacy skills. Some instruments have sucessfully been used in children as young as 5 years of age, but most have a lower age limit of 7 to 8 years.

 and is currently undergoing validation testing in children aged 7 to 18 years. For children younger than age 7, or otherwise not able to self-report, a proxy version of the Pediatric PRO-

 instrument exists. Although patient report is considered the gold standard, parent or proxy report is necessary when working with very young children and infants.

 is a library of 62 AEs which are subjective in nature and amenable for self-report in children. Fifteen core items (common across all childhood cancer therapies) have been identified: abdominal pain, anorexia, anxiety, constipation, cough, depression, diarrhea, fatigue, headache, insomnia, oral mucositis, nausea, pain, peripheral sensory neuropathy, and vomiting.

As some clinical trials span multiple ages, there is a need to consistently capture PROs accoss wide age ranges. The adult version of the PRO-CTCAE has recently been tested and proved to be well understood by children as young as 16 years of age.

 This has implications for use in clinical trials which have eligibility criteria to allow enrollment of both adolescents and older adults.

Although strong efforts have been made in adult oncology to routinely integrate PRO reporting in clinical trials, less progress has been made in pediatric oncology. Future research is needed to examine how to effectively provide healthcare practitioners with clinically useful results from PROs so that patient symptoms can be best managed in a timely manner.

One limitation of PROs is that not all patients are able to self-report secondary to literacy issues or visual/cognitive impairments. More work is needed to expand methods of capturing PROs in this disadvantaged population. Recently, the use of PROs is being explored by some as an alternative endpoint of cancer therapy.

 Open dialogue regarding PRO use within oncology is warranted as well as additional research to examine the benefits and/or limitations of integrating PROs into all cancer clinical trials.

Partner Perspectives

The voice of the patient during clinical trials must be captured, to fully record the impact of treatment toxicity and symptoms.

Capturing the Patient's Voice: Reporting Cancer Treatment Toxicities in Clinical Trials

Researchers are seeking to determine whether adding the PARP inhibitor valparib to a chemotherapy combination will improve outcomes for patients with HER2-negative, germline 

-associated metastatic or locally advanced breast cancer.

The international Brocade 3 trial, which is currently enrolling participants at more than 200 locations, seeks to randomize an estimated 500 patients in a 2:1 ratio to either veliparib with carboplatin and paclitaxel or a placebo plus the 2 chemotherapy agents (

“What we’re hoping to learn is whether, irrespective of hormonal status, the BRCA mutation is driving the response, as opposed to other factors,” explained principal investigator Shannon L. Puhalla, MD, who is director of the breast cancer clinical research program at the University of Pittsburgh Cancer Institute.

If successful, the addition of veliparib to a chemotherapy regimen would provide another option for a sizable subgroup of patients with the mutation Germline 

 mutations account for 5% to 10% of all breast cancers, from 20% to 25% of hereditary breast cancers. "Where this study will fill a void is for the patients who requires chemotherapy but also has a BRCA mutation,” said Puhalla. “Then there would be an advantage to giving the PARP inhibitor with chemotherapy.”

Nearly 78% of patients who were treated with a combination of veliparib and carboplatin/paclitaxel responded to treatment in phase II clinical trial results presented at the 2016 San Antonio Breast Cancer Symposium. However, progression-free survival (PFS) and overall survival (OS) did not meet the threshold for statistically significant improvement compared with the same chemotherapy regimen plus placebo.

Puhalla and colleagues believe there were enough positive signals in the results to remain optimistic about the prospects for success in the Brocade 3 study, however.

The phase II study also demonstrated that the backbone treatment of carboplatin and paclitaxel is extremely effective as first- or second-line therapy for patients who are BRCA mutation carriers.

Participants will be randomized 2:1 to veliparib plus paclitaxel/carboplatin or placebo with the combination chemotherapy.

The phase III trial allows for veliparib/ placebo monotherapy (depending on which arm the patient is on) if there is toxicity with combination treatment, a difference between the phase II and II trials. The primary endpoint is PFS; secondary endpoints include OS, clinical benefit rate, and objective response rate. Upon confirmation of progression, patients randomized to placebo will have the option to crossover to receive single-agent veliparib.

Women and men ≥18, with locally advanced (unresectable) or metastatic HER2-negative breast cancer who have a deleterious BRCA1 or BRCA2 germline mutation, ≤2 prior lines of DNA-damaging therapy, and stable CNS metastases are eligible for the trial.

The Brocade 3 trial is being conducted by AbbVie, which is also the company developing the drug. The study is expected to be completed in March 2018.

Clinical Trials in Progress

An ongoing trial is evaluating the addition of PARP inhibitor velaparib to a chemotherapy combination, for patients with HER2-negative, germline BRCA-associated metastatic or locally advanced breast cancer.

Phase III Trial to Examine Veliparib in BRCA Positive Breast Cancer

New standards for protecting healthcare workers, patients, their families, and the environment from unnecessary exposure to hazardous drugs (HDs) are coming next year. These standards were published in February 2016 by the US Pharmacopeial Convention (USP) in General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings of its National Formulary; they will be officially implemented July 1, 2018.

One of the new requirements is the mandatory use of closed system transfer devices (CSTDs) for the administration of antineoplastic drugs “when the dosage form allows.”

This means that nurses must use CSTDs for chemotherapy agents when the standards become mandatory.

CSTDs are devices that contain HDs when they are transferred from one container to another (eg, from vial to syringe or IV container). The National Institute for Occupational Safety and Health (NIOSH) defines a CSTD as a “drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”

Currently 10 products are available in the United States with various methods of reducing leaks and capturing HD aerosols. Each has multiple components that work together, such as vial adapters, syringe adapters, and tubing connectors. Parts from different systems are not interchangeable or compatible.

The purpose of CSTDs is to prevent the escape of HDs that may be harmful to healthcare workers while maintaining sterility of the product. Standard IV equipment is designed to protect patient safety (ie, to provide a sterile path for fluids or prevent free-flow). IV components with open-ended tubing, needles, and needleless connectors are open systems that are prone to leaking—which is not dangerous if the leaking fluid is normal saline or 5% dextrose solution.

When handling HDs, however, even small leaks are problematic. In addition to exposure of the individual preparing or administering HDs, leaking results in contamination of the environment with HD residue. That residue becomes an invisible source of exposure for others, even those not directly involved in HD handling or

the care of patients receiving the drugs.

 Nurses may think that if they are careful, their routine drug administration activities will not result in HD leaking and exposure. Multiple studies indicate that is not the case.

 In one study, for example, when nurses primed IV tubing and connected chemotherapy infusions to patients, 30.5% of the time their gloves were contaminated with the drugs.

The effectiveness of CSTDs in containing HDs has been documented since the early 2000s. Substantial published evidence indicates that the use of some of the devices has resulted in a reduction in environmental contamination and worker exposure.

Every CSTD study has demonstrated improved worker safety. USP considered this along with the fact that no other engineering controls exist for HD administration when writing the standards. These devices have the potential to minimize occupational exposure to HDs for nurses and others in areas where these drugs are prepared and administered.

CSTDs are not perfect. The ability to prevent HD exposure varies with the device. There is no performance standard or testing methodology to evaluate manufacturers’ claims of efficacy. Some product components are bulkier than other IV equipment with which nurses are familiar. Other products require nurses to use different techniques. Most require training and practice to learn how to use the devices correctly, and user error may influence containment. An additional barrier is that CSTDs add cost to each dose of drug for which they are used.

CSTDs do not solve all problems related to HD exposure. No CSTD can be used with ampules, so opening ampules and withdrawing HDs is a source of exposure (arsenic trioxide comes in an ampule). Alternative routes of drug administration may require delivery equipment that is incompatible with CSTDs, precluding their use.

Additionally, nurses must remember that any HD contamination on the outside of vials when delivered by the manufacturers is still a source of exposure, and will not be affected by CSTD use.

 Hazardous drugs and USP 800: implications for nurses. bit.ly/2mJ1IFg

 The evolution of the CSTD. bit.ly/2mmaXjE

 Closed-system transfer devices for safe handling of injectable hazardous drugs. bit.ly/2nfhP1q

When making decisions about which device to purchase, organizations must identify the CSTD that best fits with the needs of the setting. An interdisciplinary group should be involved in product selection, including pharmacists and nurses who will use the devices. The evaluation team should examine product information, including published studies supporting their containment. Compatibility with other IV equipment and ease of use should be considered. Product trials conducted under usual working conditions allow staff to see how well CSTDs fit the drug administration procedures of the practice setting.

Although barriers exist to implementing new equipment for drug administration, CSTDs represent a huge step forward for HD safety of nurses. Organizations in which CSTDs are not currently used must begin the process of incorporating these devices into practice as soon as possible, with full compliance expected by July 2018.

1. US Pharmacopeial Convention Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings. 

http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

2. Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. 

3. Hon CY, Teschke K, Shen H, et al. Antineoplastic drug contamination in the urine of Canadian healthcare workers. 

4. Hon CY, Teschke K, Demers PA, Venners S. Antineoplastic drug contamination on the hands of employees working throughout the hospital medication system. 

5. Connor TG, DeBord, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. 

6. Connor TH, Anderson RW, Sessink PJ, et al. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. 

7. Friese CR, McArdle Zhao T, et al., Antineoplastic drug exposure in an ambulatory setting: a pilot study. 

8. Rioufol C, Ranchon F, Schwietz V, et al. Administration of anticancer drugs: exposure in hospital nurses. 

9. Sessink PJ, Trahan J, Coyne JW. Reduction in surface contamination with cyclophosphamide in 30 us hospital pharmacies following implementation of a closed-system drug transfer device. 

10. Siderov J, Kirsa S, McLauchlan R. Reducing workplace cytotoxic surface contamination using a closed-system drug transfer device. 

11. Sessink PJ, Connor TH, Jorgenson JA, Tyler TG. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed-system drug transfer device. 

Feature Story

Nurses may think that if they are careful, their routine drug administration activities will not result in hazardous drug leaking and exposure, but even small leaks are problematic.

New Safety Requirements for Nurses Handling Antineoplastic Agents

“Scanxiety” refers to the fear and worry associated with imaging, both before and after a test is performed, and lasts until the test results are communicated to the patient. As described by cancer survivor Bruce Feiler in a Time magazine column, “Scans are like revolving doors, emotional roulette wheels that spin us around for a few days and spit us out the other side. Land on red, we’re in for another trip to Cancerland; land on black, we have a few more months of freedom.”

Although the word “scanxiety” has primarily been used in the context of cancer diagnosis and treatment and imaging testing, similar anxiety can be elicited when a variety of tests are performed for other diseases. The root of this anxiety is thought to be related to the uncertainty of the test results and the amount of time that elapses between when the test is performed and the results known. Not surprisingly, most patients report an escalation of anxiety that correlates with longer wait times.

In an ideal world, scanxiety could be alleviated by immediate test results. However, test results also need someone qualified to interpret them and explain their implications. When scans show no evidence of disease, or a blood test is within normal limits, the phone calls are easy to make. It’s a different story when the scans or tests are abnormal or indicate disease progression. In these cases, face-to-face conversations about treatment options are usually best.

: a 12-minute video presented by Memorial Sloan Kettering Cancer Center’s Laura Liberman, MD, FACR, a physician, breast-imaging expert, and lymphoma survivor.

So, what can healthcare providers do to reduce scanxiety? Some oncology practices schedule patients for a clinic visit on the same day a scan or test is performed. Of course, this approach only works when there is collaboration between the imaging or laboratory department and oncology providers. “The test results are not back yet” are words no patient wants to hear on a follow-up visit.

Patients who have scans and tests performed in their hometowns need to be informed that test results may or may not be available on the same day. These patients should be instructed to call their oncology providers to obtain results rather than wait for a call with the results.

Every oncology facility should have procedures that reduce the likelihood that patients will “fall through the cracks” and not be followed up. This can happen when return calls to patients go unanswered. The resulting “phone tag” is frustrating for patients and healthcare providers alike.

After-hours calls are particularly challenging, as they are often placed or received via personal cellphones. One option is to block or hide personal cellphone numbers; however, patients may ignore or decline these calls since the callers are not identified. Another option is the Doximity Dialer, an app that allows healthcare providers to call patients without revealing their personal cellphone numbers. Patients see an office or clinic number instead. The app allows healthcare providers to call patients at any US number, choose the caller ID that appears, and send return calls to an office or clinic.

The app can be downloaded for iPhone at the App Store and for Android devices at Google Play.

What else can be done to reduce scanxiety? Cognitive-behavioral therapy (CBT) may be helpful in dealing with the thoughts that are at the root of the anxiety. CBT helps by examining possible outcomes. This leads to a reduction in all or nothing, catastrophic thinking, which in turn reduces anxiety.

The bottom line is that there are a number of strategies to help patients reduce scanxiety and cope with its effects (Box). Being diagnosed with cancer is hard enough; we need to do all we can do to make the journey less stressful.

Do you have tips for helping to reduce your patients’ anxiety? Send an email to Lauren Green at 

 lgreen2@onclive.com, and we’ll share them on our website here.

Nurse's Notes

Patients with cancer know all too well the worry that accompanies waiting for test results. What can healthcare providers do to help?

"Scanxiety": Helping Patients Cope

If I could have a superpower, I’d wish to be able to speak every language in the world. The diversity of the patients I help to navigate, many who speak Spanish, Mandarin Chinese, and a variety of other languages, inspires me.

As a breast cancer screening navigator, it is my job to ensure that every woman who needs a mammogram can get one. That means helping to address patients’ barriers to care. Language can be a big barrier. Women who fear they won’t be understood by their provider tend to put off preventive health screenings, including mammograms.

Such was the case for Mrs. B, a 57-year-old retiree from Spain who had never had a mammogram. She presented with a lump in her right breast that she had felt for some time. Mrs. B had delayed going to a doctor in part because she did not want to have to rely on her son, who is bilingual and in his early 20s, to interpret for her.

She ultimately made an appointment with one of our partners, Congreso Health Center, a bilingual and bicultural primary care clinic whose patient service navigator connected Mrs. B to me for the mammogram.

I remember meeting Mrs. B and her son at that initial mammogram appointment. A certified language interpreter was there with us, and we had a seamless conversation about what to expect. Mrs. B was most relieved that her son could simply remain her son and not have to be her translator. I continued to see them—her son with her at every appointment&mdash;when they returned for the biopsy and the first visit with the provider to discuss her diagnosis and treatment. Each time, the interpreter was there, too, allowing each of us to feel understood in our roles as patient, family member, physician, and navigator. It is through these and many other interactions that I have come to value the importance of comprehensive language interpretation services as an integral part of navigation.

The next time I saw Mrs. B she was outside of the hospital waiting for her son to pull the car around. “Andrea!” she called to me from across the street. At first, I wished I had my superpower. But, even with only my basic Spanish skills, we had a meaningful interaction filled with hugs and laughter thanks to the connection we had built.

Navigating women along the breast cancer care continuum from screening to diagnosis and into treatment can reduce delays in care. This is particularly true for patients who do not speak English and may experience unique barriers to care. These may include the patient who is a no-show for appointments because he can’t read the signs to know where to go, the patient who doesn’t follow up because she can’t understand the voicemail instructing her to return, or the patient who can’t read her mammogram result letter and sees only the word “cancer” and assumes the worst. I see each of these as touchpoints with patients and an opportunity for navigation.

Mrs. RM was one of these patients who without navigation may not have received timely treatment following her diagnosis. Our community health educator, Maria, met Mrs. RM, a 36-year-old woman who had recently immigrated to the United States, at an outreach event.

She learned that Mrs. RM had received a positive breast biopsy result at an area hospital, but had not yet started treatment.

She was quickly connected with our navigation services to help her get back on track. Maria helped Mrs. RM resolve an issue with her photo ID and speak with her employer about taking time off work. I set up transportation support to help her get to and from the appointments and facilitated her insurance coverage. Her provider helped her to further understand the diagnosis and treatment options. Before navigation, simply not knowing what phone number to call to schedule the appointment had delayed Mrs. RM for months. With navigation, she was connected to care within a week. Mrs. RM transformed to become an active participant in her treatment and decision making because she felt supported and understood by those around her.

The universal language of caring is one that as navigators we all speak. It is a privilege to use it to connect with patients each and every day.

Andrea Nicholson, MPH, is a patient navigator and program manager with the Penn Medicine Breast Health Initiative at the Abramson Cancer Center in Philadelphia. The Initiative provides free breast cancer screening and diagnostic services to uninsured and underinsured women as part of the Pennsylvania Department of Health’s Healthy Woman Program with support from Susan G. Komen. Nicholson is an associate fellow at the University of Pennsylvania’s Center for Public Health Initiatives and a steering committee member of the Pennsylvania Patient Navigator Network. Nicholson attended the Harold P. Freeman Institute for Patient Navigation in 2015.

Nurse Navigators

Language barriers can mean patients put off preventive screenings, and even treatment, for fear of being misunderstood by their healthcare providers.

The Universal Language of Caring

Understandably, patients have a lot of anxiety about starting anticancer therapy. Oncology nurses play a major role in alleviating some of this anxiety by providing education about management of possible side effects. Much of this education focuses on prevention of nausea and vomiting, and other common side effects, but one often overlooked topic deserves special attention: oral care.

WHY IS ORAL CARE DURING CHEMOTHERAPY SO IMPORTANT?

Many immunotherapy and chemotherapy agents cause mucositis, an inflammatory process within the gastrointestinal (GI) tract that can affect mucosal epithelial cells from the oral cavity to the rectum. Inflammation associated with severe mucositis can lead to breakdown of the protective mucosal barrier that lines the GI tract, increasing the likelihood of systemic infection caused by GI microorganisms entering the bloodstream.

Severe pain associated with mucositis often results in decreased oral intake and malnutrition, leading to dose reduction or delays in treatment. These complications negatively impact quality of life and often require lengthy hospitalizations. Beginning oral care early and maintaining a routine throughout treatment can reduce the severity of mucositis and prevent associated complications from getting out of hand.

before starting anticancer therapy is crucial.”

WHY IS THE FOCUS ON ORAL CARE WHEN MUCOSITIS CAN AFFECT THE ENTIRE GI TRACT?

Because the oral cavity can be easily assessed without costly invasive diagnostic studies, it has become the focus of much of the research surrounding prevention and treatment of mucositis. Patients also tend to report complications related to oral mucositis because of pain management issues and malnutrition that negatively impact their quality of life. In other words, the risk of infection related to mucosal barrier injury in the colon isn’t as readily apparent to patients as painful mouth sores that prevent them from eating.

WHAT INTERVENTIONS SHOULD BE INCLUDED IN AN ORAL CARE ROUTINE?

Research has shown that some interventions definitively decrease the severity and duration of mucositis. These interventions are recommended for practice:

 or topical application of ice chips, ice water, or ice lollipops can help reduce the symptoms and pain associated with mucositis when used during administration of chemotherapy agents with short half-lives.

Sodium bicarbonate (baking soda) mouth rinses

 have been shown to be effective, although the exact mechanism of action isn’t fully understood.

 that consist of routine oral hygiene (brushing and flossing, as allowed by hemodynamic status), oral rinses, and early detection through regular assessment are also highly recommended.

Low-level laser therapy and IV palifermin

 administration have only been studied in certain populations — primarily patients with head and neck cancer receiving radiation therapy and patients undergoing hematopoietic cell transplantation. Both have shown great effectiveness in reducing duration and, in some cases, preventing the incidence of oral mucositis. 

Further research is needed in order to recommend several other oral care interventions, but enough evidence is available to suggest that the following are likely to be effective:

In a study examining mucositis among patients receiving radiation and chemotherapy, use of 

 reduced the incidence of oral mucositis when compared with placebo.

 reduced the incidence of mucositis and associated pain in several studies. However, these rinses are not recommended for treatment of existing mucositis as they can intensify pain and irritation.

 shown to reduce pain and severity of oral mucositis in a few studies are recommended by international oncology associations for patients with head and neck cancer, but additional research is necessary among larger sample sizes and other patient populations.

WHAT'S THE MOST IMPORTANT TAKE-AWAY FOR NURSES INVOLVED IN DIRECT PATIENT CARE?

Having the initial conversation about oral care with patients starting chemotherapy and immunotherapy is crucial. However, helping your patients adopt an oral care routine and performing frequent assessments for early detection of oral mucositis can greatly decrease the incidence, severity, and duration of this side effect.

Eilers J, Harris D, Henry K, Johnson L. Evidence-based interventions for cancer treatment-related mucositis: putting evidence into practice. 

. 2014; 8(6):80-96. doi: 10.1188/14.CJON.S3.80-96.

Lalla RV, Bowen J, Barasch A, et al. The Mucositis Guidelines Leadership Group of MASCC/ISOO: Clinical practice guidelines for the management of mucositis secondary to cancer therapy. 

. 2014;120(10):1453-1461. doi: 10.1002/cncr.28592.

McGuire DB, Fulton JS, Park J, et al. Systematic review of basic oral care for the management of oral mucositis in cancer patients. 

. 2013;21(11):3165-3177. doi: 10.1007/s00520-013-1942-0.

Fast Facts for the Frontline

Many anticancer therapies increase the risk of oral mucositis, leading to dose reduction or treatment delays. There are interventions that can help, and more are under study. 

 Fast Facts for the Frontline: Oral Care and Mucositis During Cancer Treatment

Statistics about the growing number of individuals joining the ranks of "cancer survivor" are truly heartening. Currently, there are more than 15 million US cancer survivors, and that number is expected to grow by at least one-third to 20 million over the next decade.

These are numbers I suspect even the most optimistic cancer research- er and practitioner might not have imagined even only a few years ago. Yet with this good news comes a re- sponsibility for the nation’s health- care providers—and not just those working in oncology. As survivorship nurse navigator Darcy Burbage notes in our cover story this month: “Survi- vorship care is everyone’s business.”

And, indeed, that chord was struck over and over again at the 2017 Can- cer Survivorship Symposium, where hundreds of researchers, healthcare professionals, survivors, and advo- cates convened for this annual conference where oncology and primary care practitioners share the latest research on providing optimal survivor care.

In this issue of Oncology Nursing News®, we highlight just a sampling of those presentations; many more can be found on Nursing.OncLive.com. And Burbage gives readers an up- close look at how survivorship care is delivered at the Helen F. Graham Cancer Center & Research Institute in Delaware, a community cancer cen- ter. It looks different, she notes, than how survivor care is delivered at larg- er academic medical centers, under- scoring a point oncology nurses know well: when it comes to survivorship, there is no one-size-fits-all approach.

Also in this issue, Pamela Gaytan, nurse and neuroendocrine specialist at the Rocky Mountain Cancer Cen- ter in Denver, provides her peers with a primer on treating and supporting patients with neuroendocrine tumors and carcinoid syndrome. Her insights are well-timed, following on the FDA’s recent approval of telotristat ethyl (Xermelo), a new drug for the treatment of carcinoid syndrome—re- lated diarrhea in these patients.

The full implementation of the new USP <800> standards for handling hazardous drugs will happen in July 2018 and oncology nurses and others who work with these agents need to be prepared.

In her column this month, nurse safe handling expert Martha Polovich explains why closed system transfer devices are mandatory under the new standards for the administration of antineoplastic agents and shares guid- ance on their use.

As always, we hope that you find the information in these pages helpful, and thank you for reading.

April 2017