In the summer of 2016, Smilow Cancer Hospital at Yale New Haven Health, a large, National Cancer Institute—designated comprehensive cancer center, introduced 4 inpatient virtual hospice beds—and oncology nursing leadership identified an opportunity to evaluate the coping needs of staff who care for actively dying patients. The beds, implemented in partnership with a regional hospice service, were placed on the medical oncology and gynecologic oncology units.

 and subsequent turnover, 3 nurses representing the 2 inpatient units participating in the 2015-2016 University HealthSystem Consortium (UHC)/American Association of Colleges of Nursing (ACCN) Nurse Residency Program evaluated the impact of a meditation intervention on staff perception of stress.

The evaluation was performed using a 3-step process: an initial survey to gather demographic information about the nursing and support staff, a Likert scale to determine baseline subjective stress levels, and another Likert scale to measure levels after the intervention using guided imagery, a form of meditation.

Thirty-four staff members from the medical oncology and gynecologic oncology units participated, including registered nurses, nurse educators, and patient care associates. The initial survey consisted of 10 questions to identify participants’ perceptions of 

 and related to actively dying patient care, years of experience, and coping mechanisms for dealing with work-related stress. The participants then completed a Likert scale survey associated with the statement “I feel stressed,” with responses ranging from 1 (strongly disagree) to 10 (strongly agree). Next, all participants listened to a guided relaxation audio provided by Smilow Cancer Center’s Integrative Medicine Department. The 10-minute exercise and survey took place in a conference room during a change of shift or 

Afterward, participants were asked to again respond to the “I feel stressed” statement on the scale of 1 to 10. Evaluation of the pre- and post-intervention data revealed that the majority of nursing staff experienced a decrease in perceived stress level after using guided imagery.

The remaining minority of nurses attributed their unchanged stress level to the responsibility of a patient assignment during the evaluation and intervention, timing of the evaluation (eg, during a shift change), and the voice on the audio.

Interestingly, none of the 4 participating patient care associates identified caring for actively dying patients as a stressful event; therefore, there was no change in evaluation of stress after guided imagery.

Further exploration into differences in nursing and support staff stress levels is warranted, and monitoring of turnover post-intervention is in progress. A standardized tool to evaluate stress and perception of burnout, as well as a list of standardized definitions of words and phrases frequently used in the survey and discussion (eg, “comfort measures only,” “actively dying patient,” and “compassion fatigue”) would help provide a concrete reference for participants. For example, nurses and nursing support staff define “actively dying patient” differently: While one nurse might use that term to describe the majority of patients on the medical oncology or gynecologic oncology units, another staff member might consider only a patient with agonal breathing or “comfort measures only” code status as actively dying.

This gray area of definition may have affected perception of stress in the overall results. Another area for further study may be use of the Professional Quality of Life (ProQOL R-IV) scale, a standardized tool for evaluating perception of stress. Overall, the project provided a great foundation for further examination into the areas of self-care for nurses. Guided imagery offers an easy, feasible, and effective coping strategy that staff who take care of actively dying patients can use while on duty.

This project invites discussion into promoting wellness and mental health of the staff—specifically, those who care for patients transitioning to hospice.

The author acknowledges Mercy Asomaning, RN, and Kelsey Osinski, RN, for their help in the implementation of the project.

graduated from the University of Connecticut in 2015. She now works as a clinical nurse II at Smilow Cancer Hospital at Yale New Haven.

Articles

Partner Perspectives

Guided imagery intervention helped evaluate perceived stress levels among registered nurses, nurse educators and patient care associates.
 

Survey Examines Burnout of Nurses Caring for Actively Dying Patients

It’s gift-giving season again—although for oncology nurses, managing material expressions of gratitude happens all year long, not just during the holidays. This can be a complex issue for all healthcare providers but especially oncology nurses, who develop a special, unique bond with patients and their families, who often want to show tangible appreciation for their care.

Do you or don’t you accept a gift from a patient? Is a certain type of item or dollar amount OK? What about baby gifts or wedding presents?

The short answer: maybe. Although it is never appropriate for a nurse to accept a gift of a large monetary value—be it an item or cash, a gift card, or tickets to a concert, the theater, or sporting events &mdash;smaller tokens of appreciation might be acceptable. Consider the following situation.

When I was in my first year of practice as an oncology clinical nurse specialist (more than 30 years ago), my patient Lin offered me a personal gift. Sure, I had been the recipient of many gifts— flowers, chocolate candies, homemade food&mdash;but all had been shared with the entire staff. This situation was different: She was presenting me with a small, hand-embroidered hankie. No note, no verbal thank-you&mdash;just a smile and a bow. I had first met Lin about 10 months before, when she was diagnosed with acute lymphoblastic leukemia. She had worked long, hard hours as a housekeeper; had a devoted husband and 2 beautiful boys, both in elementary school; and barely spoke English. I was the nurse who helped her understand her diagnosis, her access device, and her complex 2-year chemotherapy protocol, with all its adverse effects. She had just finished her initial phase of intense treatment and was transitioning to maintenance therapy.

I carefully and quickly evaluated the situation based on some of what I had learned in nursing school about accepting gifts:

 It definitely was homemade. I wondered how Lin had done such beautiful needlework, considering her peripheral neuropathy.

 We had a long-term but always professional relationship.

 Her gift was offered as she completed initial treatment.

I truly believed it was a heartfelt thank you and not a quid pro quo.

Rejecting her gift could be perceived as devaluing it and being rude or impolite.

I accepted her gift with a sincere “thank you,” and then shared the situation at my next meeting with my manager. This incredible leader simply asked, “Would you do anything differently next time?” What I have since learned is that I need to ask myself additional questions:

Could the gift be viewed by others as a tip, bribe, or favor?

Is the giver seeking preferential treatment?

Would accepting the gift change my professional, therapeutic relationship with this patient or any of my other patients?

Could accepting this personal gift affect my relationship with my colleagues?

What do my organizational policies or professional standards say?

We want our patients to know that we treat all patients equally, regardless of their ability to pay or give gifts. The receipt of anything other than a token gift of low monetary value could compromise a professional, therapeutic relationship. The challenge is defining “token gift,” which can be very subjective.

Many employers have created policies in an attempt to prevent any perceived conflict of interest. For example, one healthcare organization states in its code of conduct that employees “will never accept gifts of money or cash equivalent, including gift cards from patients or their families.” The National Council of State Boards of Nursing states that “accepting inappropriate gifts (beyond a thank-you card or a gift of food to the unit, etc) is a warning sign in crossing professional boundaries.”

So how can you handle the offer or presentation of a gift? If it is expensive or could be perceived as more than a token gift, then politely decline it. Let the giver know that accepting gifts is against your employer’s policy. Suggest that they instead:

Bring popcorn, cookies, a meat and cheese tray, or fruit to share with the entire staff (divided into 2 or 3 platters so all shifts can enjoy).

Complete an employee recognition form (provide the document or link) or write a letter.

Make a contribution to the clinic, unit, or facility; often, a foundation has a fund.

Donate to their favorite cancer charity in honor of you or the clinic or unit.

If you have any questions about receiving a gift or concerns about a colleague who accepted one, start by reviewing your organizational guidelines. Have a direct discussion with your colleague or your manager, explaining the reasons for your concern and the potential impact for the patient, other patients, and staff.

Consider championing a proactive approach at your facility to clearly communicate that staff are not allowed to receive monetary gifts or the equivalent. Create a statement—e.g., “It is our policy that staff may not accept gifts of any kind”&mdash; that can be shared with new patients in their information packet about the facility, parking, visitors, etc, and suggest alternatives for redirecting gifts.

Remember that most patients just want to show their appreciation and that for some people, visible symbols of caring and love speak the loudest. And yes, I still cherish my hankie from Lin, who died a few months after I received my gift.

Professionally Speaking

Accepting gifts can be a complex issue for all healthcare providers but especially oncology nurses, who develop a special, unique bond with patients and their families, who often want to show tangible appreciation for their care.

Gifts From Patients: Accept or Reject? 

Sydney J. Harris, an American author and syndicated columnist for the 

, wrote that the words information and communication often are used interchangeably but signify different things. Harris, who died in 1986, astutely noted that “information is giving out and communication is getting through.”

Effective communication is an interactive process, with both parties mutually engaged in the conversation. However, all too often our interactions are anything but effective—and in oncology practice, poor communication with patients can lead to confusion or misunderstanding and potentially compromise patient care.

To identify best practices for effective communication with patients with cancer, the American Society of Clinical Oncology convened a multidisciplinary panel of experts in medical oncology, psychiatry, nursing, hospice and palliative medicine, communication skills, health disparities, and advocacy to review the literature and formulate recommendations. The panel addressed several areas, ranging from identifying core communication skills to describing strategies for related training.

One of the core recommendations is to determine the patient’s understanding of his or her disease, clinical status, and prognosis. Sounds simple enough, but many patients do not fully know or understand the extent of their disease. I still remember the patient who watched the oncologist draw the anatomy of the colon on exam room paper and write survival statistics next to it, yet when I asked that patient what he knew about his disease, he said, “I have a 60% cancer of the semicolon.” That type of response illustrates the importance of assessing the patient’s understanding.

Patients often get flustered when asked to repeat what they have been told or taught. A better way to assess their understanding is to say, “I want to be sure I’ve done a good job explaining this. Please recap what we’ve been talking about.”

When a misunderstanding is identified, the clinician can respond, “I haven’t done a very good job explaining this,” and then use a different approach to convey information.

Prior to each conversation, the clinician should review the patient’s medical information, establish goals for the conversation, and anticipate the needs and responses of the patient and family, according to the recommendations. Providing information is easy but skips the step of mutually establishing goals for the conversation. Teaching about treatment adverse effects, for instance, will be ineffective if the patient is focused on the unexpected news of a cancer recurrence.

Simply asking “What would you like to discuss or learn about during today’s visit?” can identify the patient’s needs and priorities and reduce time wasted discussing topics of little or no interest to the patient.

When patients who are asked what they’d like to talk about say that they have nothing specific to discuss, consider asking “What is of most concern to you right now?” The answers often are surprising and may be completely unrelated to the patient’s cancer treatment. This question also helps individualize documentation of the patient’s visit.

Another recommendation centers on patients’ awareness of all treatment options, including clinical trials and palliative care, which can be initiated simultaneously with other treatment modalities when appropriate. The panel used the term bidirectional in reference to discussions of end-of-life care and advised starting conversations about the patient’s preferences early in the course of incurable disease, readdressing the topic periodically, based on the patient’s clinical course.

“Enter clinical encounters with a sense of curiosity, aware that any patient and family, regardless of their background, may have beliefs, experiences, understandings, and expectations that are different from the clinician’s,” recommends the panel.

In practical terms, that means suspending judgment and making an effort to learn more about the patients. It also presents an opportunity to examine our biases and assumptions and learn more about ourselves, as well.

The experts recommend communication skills training for clinicians that includes learning about self-awareness and situational awareness related to emotions, attitudes, and underlying beliefs that may affect communication. One strategy to develop awareness involves reflecting on difficult, challenging, or unpleasant patient encounters, along with considering the elements of patient care that are satisfying or provide a sense of meaning.

The consensus guidelines, published on September 11, 2017, are available at ascopubs.org/doi/full/10.1200/JCO.2017.75.2311. To facilitate communication skills training, a number of no-cost resources have been developed, including slide sets, a data supplement, and clinical tools and resources (accessible at asco.org/supportive-care-guidelines). A 13-page summary of the guidelines also is available (consider posting 1 page a week in the workplace), along with patient resources, including videos on talking with a healthcare team, a list of questions to ask, tips to facilitate communication, and navigating challenges, such as making decisions, managing costs, and finding emotional support.

Nurse's Notes

To help convey effective messages, nurses should determine how much of the disease a patient understands.
 

Information Is Giving Out, Communication Is Getting Through

Throughout the course of treatment, many patients with cancer receive chemotherapy, intravenous fluids, antibiotics, and much more via central venous catheters such as Mediports. It is crucial that oncology nurses perform proper technique and site maintenance to prevent infection and avoid infiltration or extravasation. Providing comprehensive patient education can prevent foreseeable issues and improve patient outcomes.

Several types of intravenous ports are available, and knowing which one is being used can provide clues regarding how to access and dress it.

For example, there are both single and double lumen ports. To find out which type a patient has, checking the radiology report always helps, but it usually can be determined by feeling for the septum(s). This is especially important when accessing a double lumen port, because the orientation can differ and even move slightly (septums are situated either side by side or superior and inferior). Some ports—mainly, single lumen ones&mdash;have raised bumps along the septum’s edge that make it easier to identify an exact access point.

A patient might have a PowerPort, a device that allows rapid injection of the contrast agent or dye during radiological exams. Depending on the treatment plan and the last date of access, one or both ports may need to be accessed. Once the type of port is determined, the nurse can plan supplies and method of access. The same technique is used whether accessing 1 or both ports, and 1 dressing will adequately cover both sites.

Feeling for the septum is not always straightforward. Depending on the patient’s anatomy and weight, the port can be difficult to locate, especially if mild swelling post-surgery is present.

A port is typically placed on the right side of the patient’s chest and about 3 to 5 fingerbreadths below the clavicle. The insertion scar provides a useful landmark, because the port is usually located 0.5 to 1 inch below the surgical incision.

Bringing a patient who has large amounts of breast tissue to a fully upright position, with the right shoulder rotated toward the patient’s backside, can aid in visualizing or feeling the port access site.

Understanding the available needle types can help the nurse execute the best possible access to the port. Consider these questions: What is the most comfortable way to hold and insert this particular needle? Are butterfly wings present? Do any pieces require removal before or after access?

Proper needle length is crucial for preventing infiltration and/ or extravasation. Although a ¾-inch needle is widely used, a particular patient may require anywhere from 1 to 2 inches.

Once inserted, the nurse should be able to feel the needle’s tip gently tap the plastic or metal backing of the port. Once accessed, the needle should lay relatively flat against the patient’s chest and blood return should be present, along with an easy, pain-free saline flush.

Maintain a sterile field with all equipment needed for access, including any dressings, flushes, valves, etc. This is critical for infection prevention, as well as ease of access and time management.

Allow proper dry time for any skin cleanser, such as ChloraPrep, to help prevent not only infection but also a rash. A dressing placed before the cleanser fully dries can cause a red raised rash that might be confused for a dressing allergy.

Ensure that the needle is primed with saline. However, many hospital policies differ slightly in best practice for port access.

Stabilize the port with the nondominant hand prior to access to improve Mediport access success rate.

Although rare, it is possible for ports to flip.

Emphasize the benefits of an implanted port: It avoids many painful venipuncture attempts and provides a stable line if urgent medication is needed. This knowledge can help allay patients’ fears and solidify their decision when selecting a port.

Explain what to expect regarding a new port site. Bruising and swelling should subside. If steri strips were used, ensure the patient is aware to let them fall off on their own. Removing them prematurely could reopen the incision and increase the risk of infection.

Educate patients on monitoring for signs of infection, both systemic and at the port site. Be sure they know what symptoms require medical attention: fever and abnormal swelling, redness, warmth, or drainage, especially during healing.

Be sure patients who have implanted ports understand that, once the site heals, they will have more freedom of activity, because the port is completely under the skin and protected (once healed). They can shower normally and even swim when the port is not accessed, although participating in contact sports is not advised as injury to the port site is possible.

Remind patients remaining accessed for multiday infusions that the site must stay clean and dry. Many patients like to use AquaGuard dressings, which help protect the site from water.

Instruct patients that, if not in use, a port should be accessed and flushed once a month to maintain patency.

 is a freelance healthcare writer and owner of AHayWriting.com with over 10 years of nursing experience in several areas of pediatric and adult oncology.

Fast Facts for the Frontline

Basic knowledge of types of intravenous ports can help nurses who manage these for patients.

Know Your Ports

Cancer does present an initial hardship for patients. But in the days, weeks, months, and years after treatment has started and stopped, the adverse effects (AEs) become an even greater challenge. Patients may present with common AEs such as nausea, alopecia, fatigue, and depression. However, low blood counts, diarrhea, shortness of breath, weakness, and skin alterations also plague them. These can be severe and debilitating for a patient and may negatively affect their day-to-day living, such as going to work, visiting with a friend, taking care of a household, or attending a child’s school event.

Symptom burden is an area in which oncology nurses can make improvements for their patients. In our cover story in the November/December 2017 issue of 

 Carlton G. Brown, PhD, RN, AOCN, NEA-BC, FAAN, shares his expertise on symptom management. He discusses proactive solutions such as interventions used in cancer centers that have proven to be effective in symptom control and longer tolerance of treatment. Knowing the common symptoms associated with different cancer types and having access to guidelines, which Brown discusses, can lead nurses to deliver quality care for those fighting the disease.

, tips on how to locate an intravenous port, choosing a needle, and ensuring successful access. A topic that many nurses can relate to: stress and burnout. Inside these pages, we explore a study that examined the burnout of nurses caring for actively dying patients. You will read about what researchers learned and the coping strategy they found to be effective.

Finally, the holiday season is among us. This means gift giving—something nurses encounter not only at this time of year. What should you do if a patient or their loved one offers you a present? This month’s Professionally Speaking column explores simple, yet useful, questions you can ask yourself before accepting or rejecting. Plus, advice on to how navigate the situation without hurting anyone’s feelings.

Also inside, the keys to effective communication with patients, fears and misconceptions of radiation therapy, and boosting quality of life for patients through yoga. We hope you find these articles informative, and as always, thank you for reading.

From the Chairman

This letter from the Chairman and CEO of Oncology Nursing News gives an overview of the contents of the December 2017 print magazine. 

Putting Patients' Adverse Effects to the Top of the List

Carlton G. Brown, PhD, RN, AOCN, NEA-BC, FAAN

It is estimated that well over 1.6 million Americans will be diagnosed with some form of cancer in 2017. Many of these patients will be treated with chemotherapy, immunotherapy, radiation, surgery, or a combination of these therapies. For patients with cancer, the diagnosis and treatment of the disease create very complex experiences, which usually include one or more adverse symptoms.

Often, we think only about symptoms that result from treatment, such as alopecia and nausea. However, even before undergoing treatment, patients with cancer may present with many symptoms, including low blood counts (red and white blood cells, platelets), bleeding, fatigue, pain, and difficulty urinating or defecating. In fact, these troublesome symptoms often lead patients to seek some form of healthcare to alleviate the burden.

Treatment for cancer comes with a host of potential adverse effects (AEs)—pain, nausea, vomiting, fatigue, depression, diarrhea, cough, shortness of breath, weakness, mucositis, and skin alterations, to name a few. Some treatments are well known for their potential AEs. For example, it is common knowledge that some chemotherapy drugs cause high levels of nausea or vomiting. Some targeted anticancer strategies, such as epidermal growth factor receptor inhibitors, result in AEs like dermatologic toxicities.

 Radiation treatments often have long-term or permanent effects, such as salivary gland damage or alopecia.

Furthermore, it is not unusual for patients to experience 2 or more symptoms at the same time. Take, for instance, the patient receiving chemotherapy who has mucositis, nausea and vomiting, depression, alopecia, and pain—all at once. Just 1 of those symptoms might be deemed unbearable; combined, they could result in a tremendously debilitating situation. Ineffective or absent symptom management can create poor quality of life and other undesirable outcomes for patients.

Excellent symptom management does not need to be a hopeless situation. It might seem obvious, but oncology nurses have incredible opportunities to make improvements for patients with cancer, regardless of whether the person is undergoing treatment.

The results of a study by Jennifer Temel, MD, and colleagues

 from Massachusetts General Hospital showed that a palliative care nurse-driven intervention significantly improved both quality of life and mood (reducing anxiety and depression) for patients with metastatic non—small cell lung cancer. Further, the researchers found that, compared with patients who received standard care, patients receiving early palliative care from nurses had less aggressive care at the end of life but longer survival.

Not only are oncology nurses the perfect conduit for providing excellent symptom management, but they have also led the way in related research and, just as important, developed evidence-based guidelines, such as the Oncology Nursing Society (ONS) Putting Evidence into Practice (PEP) resources (ons.org/practice-resources/pep). According to ONS,

 teams of nurse scientists, advanced practice nurses, and bedside and chairside nurses synthesized evidence into PEP topic areas and created resources that all healthcare teams can use for patients with cancer.

Remarkable progress has been made in the science around managing adverse symptoms in patients with cancer. The progress in supportive care of patients includes the establishment of systematic reviews by organizations, such as ONS with PEP, and the creation of National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines).

 The NCCN Guidelines provide documented, evidence-based recommendations for symptom management, including pain relief, antiemetic therapy, and palliative care. Now, more than ever before, there are practice guidelines for managing virtually every symptom that patients with or being treated for cancer might experience.

Proactive symptom management should not be an elusive goal—certainly, we possess the knowledge of how to treat many adverse symptoms. Still, a few significant issues seem to get in the way. One barrier to proactive symptom management, especially for patients at home or in an outpatient setting, is that it is difficult for clinicians to know when a particular symptom occurs. Sometimes the patient will communicate about the problem much later, such as at a follow-up appointment. Other times, patients will decide to stop or reduce a treatment because a debilitating symptom went unmanaged. Ideally, a clinician would know when a patient is experiencing a symptom and immediately provide interventions almost in real time. Finding ways to logistically deliver those evidence- based interventions to oncology nurses and other healthcare providers, so they can use them for patients experiencing symptoms, presents another barrier.

Yet another concern regarding symptom management: Patients are not constantly monitored by the oncology team. Even when patients are with their team, it is estimated that doctors and nurses miss many of the symptoms that arise during treatment.

A technological solution to problems with proactive symptom management involves a web-based patient-reported outcome (PRO). This system, which requires Internet access and a computer, phone, or tablet, asks patients if they are experiencing debilitating symptoms.

The information from the patient is relayed to the team of doctors and nurses so that they can intervene appropriately and almost instantly — this is especially important for symptoms that are considered critical, like pain, diarrhea, nausea, and vomiting.

found in a randomized controlled trial of 766 patients receiving chemotherapy for metastatic cancer at Memorial Sloan Kettering Cancer Center in New York City, that participants who used a web-based PRO had significantly improved outcomes compared with patients receiving usual treatment. Specifically, patients using the system had improved quality of life, better symptom control, and fewer emergency department visits and hospitalizations, and—perhaps most important&mdash;they were able to remain on chemotherapy longer. Patients using tablets received weekly e-mail prompts to report symptoms between visits. Nurses received e-mail alerts when patients reported severe or worsening symptoms, and physicians were given symptom printouts at visits.

Kathleen Mooney, PhD, RN, FAAN, and colleagues

 at the University of Utah used Symptom Care at Home (SCH)—an automated monitoring system focused on 11 symptoms&mdash;daily for 358 patients receiving chemotherapy. The patients received automated self-management coaching, and a nurse practitioner followed up with a phone call for poorly controlled symptoms. In this randomized controlled trial, patients on the SCH intervention had significantly less severity across all symptoms and significant reductions in severe and moderate symptom days compared with patients receiving usual care.

So, it appears that patients whose symptoms are monitored proactively via web-based technologies have better symptom control and tolerate treatments longer, which may help deliver control or survival of cancer.

Another intervention that aids proactive symptom management involves preloading evidence- based practice guidelines into electronic medical records (EMRs). When a patient reports a debilitating or troublesome symptom, either in person or via a web-based PRO, as soon as the assessment is documented in the EMR, a care plan should become available for the nurse or physician.

This immediate evidence-based intervention provides almost instant and very proactive symptom management for patients with cancer, whether or not they are undergoing treatment. For example, during a chemotherapy administration appointment, a patient may report hiccups that lasted 24 hours. The nurse assesses and documents that symptom in the EMR and immediately receives a set of evidence-based practice interventions for consideration—as opposed to assessing, documenting, and then turning away from the patient to search for a specific intervention. That can delay or even terminate the timely delivery of a symptom management intervention, a void in time that could be eliminated by having the plan of care readily present in the EMR and available to nurses and at the point of care. Because EMRs do not always include these interventions, some companies have created evidence-based guidelines that can be loaded directly into most EMRs.

Superior symptom management is crucial for patients with cancer. Oncology nurses are in the best position historically to provide the highest quality care. Nurses know the most common symptoms associated with almost every cancer treatment and have access to credible, evidence-based practice guidelines for cancer symptoms. Yet, patients experience untreated symptoms every day, resulting in poor quality care and, in some instances, causing patients to delay or terminate a treatment that is imperative for cancer cure or control. Oncology nurses can do better; with greater use of a few new tools available for proactive support, improvements for symptom management are on the horizon.

1. American Cancer Society. Cancer facts & figures 2017. https://www.cancer.org/content/dam/cancer-org/ research/cancer-facts-and-statistics/annual-cancerfacts-and-figures/2017/cancer-facts-and-figures-2017. pdf. Accessed October 20, 2017.

2. Hofheinz RD, Deplanque G, Komatsu Y, et al. Recommendations for the prophylactic management of skin reactions induced by epidermal growth factor receptor inhibitors in patients with solid tumors. 

. 2016;21(12):1483-1491. doi: 10.1634/theoncologist.2016-0051.

3. Temel, JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. 

. 2010;363(8):733-742. doi: 10.1056/ NEJMoa1000678.

4. Oncology Nursing Society. PEP rating system overview. ons.org/practice-resources/pep. Accessed October 23, 2017.

5. National Comprehensive Cancer Network. NCCN Guidelines. www.nccn.org/professionals/physician_gls/default. aspx#supportive. Accessed October 20, 2017.

6. Basch E, Deal AM, Kris MG, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. 

. 2016;34(6):557-565. doi: 10.1200/JCO.2015.63.0830.

7. Mooney, KH, Beck SL, Wong B, et al. Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. 

. 2017;6(3):537-546. doi: 10.1002/cam4.1002.

Cover Story

Early palliative care and web-based systems are effective solutions that helped boost quality of life.

Take Charge: Proactive Steps to Ease Patients' Symptom Burden

PEGPH20 (pegvorhyaluronidase alfa), a novel formulation of a naturally occurring enzyme, is being investigated as a biomarker-driven treatment for patients with advanced pancreatic cancer.

Researchers are testing the drug, a PEGylated recombinant human hyaluronidase enzyme, in combination with standard-of-care gemcitabine and nab-paclitaxel (Abraxane) in patients with stage IV treatment-naïve pancreatic cancer whose tumors express high levels of hyaluronan (HA). PEGPH20 degrades HA, a carbohydrate that can build up in the tumor microenvironment and block the delivery of anticancer therapies.

The phase III, randomized, multicenter HALO-301 trial seeks to recruit 420 patients with advanced, metastatic pancreatic ductal adenocarcinoma, including patients with disease progression that occurs following resection 6 months or longer after their last therapy (NCT02715804).

“This is a biomarker-stratified trial because we learned from retrospective analyses that the patients who benefit most from this enzymatic strategy to degrade HA are those with the highest levels of HA in their tumors,” said Sunil R. Hingorani, MD, PhD, director of the Center for Accelerated Translation in Pancreas Cancer at the Fred Hutchinson Cancer Research Center in Seattle and a professor at the University of Washington School of Medicine.

The rationale for the HALO-301 trial was established in the phase II HALO- 202 study, which randomized 279 and treated 260 patients to PEGPH20 combined with gemcitabine and nab-paclitaxel versus the chemotherapy agents alone.

The median progression-free survival (PFS) difference in the 2 regimens was modest but statistically significant in favor of the PEGPH20 treatment arm (6.0 vs 5.3 months, respectively). In patients with HA-high tumors (n = 84), the median PFS benefit was significantly higher in the PEGPH20 arm at 9.2 months, compared with 5.2 months with chemotherapy alone.1

One of the main adverse effects (AEs) associated with PEGPH20 is the increased risk of thromboembolic and clotting events. In the HALO-202 study, the thromboembolic event rate was 43% in the PEGPH20 arm, compared with 25% in the chemotherapy arm.1

Other significant AEs of any grade in the PEGPH20 arm included peripheral edema (63%), muscle spasms (56%), neutropenia (34%), and myalgia (26%). Febrile neutropenia was rare and did not differ between the 2 arms.1

Although PEGPH20 has shown efficacy in this patient population, the HALO-301 trial will determine whether it is a feasible treatment option in combination with gemcitabine and nab-paclitaxel in the firstline metastatic setting.

Eligible patients will be randomized 2:1 to be treated with either PEGPH20 plus standard-of-care gemcitabine and nab-paclitaxel or the chemotherapeutic agents alone with a placebo. Investigators will be looking at PFS and overall survival as the primary endpoints, with overall response rate, duration of response, and safety as secondary endpoints.

The Ventana HA CDx Assay, a companion diagnostic developed by Ventana Medical Systems, will be used to conduct HA testing. The test is a recombinant HA binding probe designed to be used with the Ventana OptiView DAB IHC Detection Kit on formalin-fixed, paraffin-embedded pancreatic tumor samples.2

The assay was tested for its interreader precision by 3 pathologists who evaluated 100 tumor samples with varied HA expression levels. The evaluation showed agreement rates greater than 94%, which investigators said demonstrated the assay’s “high robustness and reproducibility.”2

All prospective participants will be tested for HA levels in their tumors. HA-high tumors are defined as having HA staining on greater than 50% of the tumor surface in the extracellular matrix; those with low levels (<50%) will be excluded. Additionally, participants must have an ECOG performance status of 0 or 1, as well as no evidence of deep vein thrombosis, pulmonary embolism, or any other known thromboembolic event.

1. Hingorani SR, Bullock AJ, Seery TE, et al. Randomized phase II study of PEGPH20 plus nab-paclitaxel/gemcitabine (PAG) vs AG in patients (Pts) with untreated, metastatic pancreatic ductal adenocarcinoma (mPDA). 

. 2017;35(suppl; abstr 4008). http://meetinglibrary.asco.org/record/ 144526/abstract.

2. Khelifa S, Pu J, Aldrich C, et al. Development of a companion diagnostic assay for tissue hyaluronan detection and treatment with PEGPH20 in metastatic pancreatic ductal adenocarcinoma patients. 

. 2016;34 (suppl; abstr e15749). http://meetinglibrary.asco. org/record/127997/abstract.