explores the intersection between obesity, cancer, and underserved patients.

Obesity can cause health complications among the general population of the United States, but patients with cancer who are obese face additional health risks. Some rural and minority populations face further challenges, such as lack of access to care and healthy food, as well as unhealthy food-related regional or cultural traditions. In this issue’s cover article, experts weigh in on how nurses can have a great impact on patients’ awareness of their risks, as well as how to communicate steps to take to reduce them.

Oncology nurses can play many roles in the healthcare ecosystem to support patients with cancer. When one nurse experienced the effects of chronic medical challenges, she channeled her expertise toward writing about nursing instead. Read this month’s feature story about Ashley Hay and her journey from clinical nurse to freelance writer. Editor in Chief Lisa Schulmeister reviews the practice of scalp cooling to reduce hair loss, and how it is becoming more common, in her “Nurse’s Notes” column. Another article covers the use of placebo and its growing use in cancer clinical trials.

All of the articles in the Clinical Insights section focus on chimeric antigen receptor (CAR) T-cell therapy research and practice. Read about the potentially game-changing preclinical development of off-the-shelf CAR T-cells that don’t require personalization and may be able to be mass-produced. Other articles highlight studies in myeloma, lymphoma, and leukemia treatment with this therapy, and review the role of nurses who care for patients receiving it.

As always, we strive to bring you practice-based information that can help you stay current in the field of oncology nursing. We hope you find this issue useful and enlightening.

Articles

From the Chairman

This letter from the Chairman and CEO of Oncology Nursing News gives an overview of the contents of the July 2018 print issue of the magazine.

A Weighty Matter

Unavoidable emotional workplace stressors may threaten personal health and occupational wellbeing of clinicians who care for patients with cancer.

 Although advances in diagnostic technology and expanding treatment options have improved survival rates for individuals with many cancers, patients and their families are exposed to continued suffering as they endure often debilitating treatments and disease progression. Oncology providers carry a high risk of developing compassion fatigue, psychic strain, and exhaustion as a result of chronic exposure to others’ pain.

Oncology care providers also face increasing patient care load and more time away from the patient for computer documentation.

 Occupational stress increases healthcare providers’ risk for work-related injuries and illness and can reduce the quality of patient care providers are able to give.

 Evidence-based ameliorative strategies are critically needed to change how providers experience and respond to workplace stressors.

Meditation can relieve stress, cultivate self-regulation skills, and modify risk and symptoms of compassion fatigue and work-related burnout.

 Workplace training typically offers mindfulness-based stress reduction, a composite group of practices that obscure the source of potential benefits. These programs are traditionally offered via group formats requiring lengthy time commitment and fixed scheduling, thus reducing their feasibility for busy health professionals with demanding personal schedules.

To offset the time-prohibitive delivery barrier, we, along with colleagues Marcel Allbritton, PhD, Michelle Wiseman, MPA, RN, and Tom Day, MA, developed and tested a 6-week cybermeditation program we delivered via email and a mobile app.

The program included five 10-minute meditations (Calming, Nature, Nourishing, Spaciousness, and Releasing) grounded in the Krishnamacharya—Desikachar approach to yoga for healing known as yoga therapy.

 These meditations were tailored to address the work stressors of oncology professional healthcare providers. The meditations were designed to be effective in changing the state of the human system in the direction of mental focus yet also be accessible to individuals new to yoga and meditation and those with limited physical strength and flexibility.

We conducted pre- and poststudies with 36 palliative/hospice professional healthcare providers who participated in the cybermeditation program.

 After completing presurveys, participants downloaded and used the cybermeditations: 1 new program used regularly throughout each week for 5 weeks, with 1 extra practice week. We conducted 3 follow-up focus groups and 1 in-depth interview.

Results showed that the program motivated regular use, significantly improved interoceptive awareness, and reduced compassion fatigue and burnout (TABLE). Twenty-five percent (n = 9) averaged fewer than 2 meditations, 42% (n = 16) completed 2 to 4 meditations, and 33% (n = 13) completed more than 4 meditations per week over the 5-week period. Two-thirds (n = 24) reported being somewhat to very likely to continue using the app after the program ended.

Focus group interviews revealed diverse approaches to how the apps were used.

 For example, some healthcare providers used the cybermeditations almost every day on a set schedule, whereas others used the apps on difficult days. Participants reported recalling particular breathing, movements, or meditation objects from the apps during stressful work moments, using associated memory of how they felt doing the meditation to buttress most appropriate responses to situations.

The study demonstrated effectiveness of the shorter length, portability, and convenience of the app and the brief informational and motivational support emails that minimized time demands compared with meditation interventions used in most studies. The cybermeditation program is scalable, optimizing both reach and efficacy and, once normed, can be adapted for other groups. Although scientific testing is still in early stages, the approach could potentially transform the delivery and effectiveness of meditation training programs for the healthcare industry.

Carrie Heeter, PhD is a professor of media and information at Michigan State University. She designs and researches cybermeditation. She is a certified Viniyoga and meditation teacher. Heeter has studied meditation one-on-one for 6 years with Marcel Allbritton, PhD.

Rebecca Lehto, PhD, RN is an associate professor at Michigan State University College of Nursing and a former oncology clinician. Her research focuses on symptom management and adaptation to cancer.

Boyle DA. Compassion fatigue: the cost of caring. 

 2015;45(7):48-5 doi: 10.1097/01.NURSE.0000461857.48809.a1.

Back AL, Steinhauser KE, Kamal AH, Jackson, VA. Building resilience for palliative care clinicians: an approach to burnout prevention based on individual skills and workplace factors. 

. 2016;52(2):284-291. doi: 10.1016/j.jpainsymman.2016.0002 .

Back AL, Rushton CH, Kaszniak AW, Halifax, JS. “Why are we doing this?”: clinician helplessness in the face of suffering. 

 2015;18(1):26-30. doi: 10.1089/jpm.2014.0115.

Boyle D. Occupational stress in oncology nurse caregiving: caring for ourselves. 

2015;19(5):499-499. doi: 10.1188/15.CJON.499.

Gómez-Urquiza JL, Aneas-López AB, Fuente-Solana EI, Albendin-Garcia L, Diaz-Rodriguez L, Fuente GA. Prevalence, risk factors, and levels of burnout among oncology nurses: a systematic review. 

. 2016;43(3):E104-E20. doi: 10.1188/16.ONF.E104-E120.

Sauter S, Murphy L, Colligan M, et al; National Institute for Occupational Safety and Health. Stress...at work. Centers for Disease Control and Prevention website. cdc.gov/niosh/docs/99-101/. Updated June 6, 2014. Accessed July 28, 2018.

Back AL. How Contemplative Practice Infuses Clinical Practice with Serious Illness. Int. Symp. Contempl. Stud. [Internet]. Boston, MA; 2014. iscs2014.org.

Sorensen G, Nagler EM, Hashimoto D, et al. Implementing an integrated health protection/health promotion intervention in the hospital setting: lessons learned from the Be Well, Work Well study. 

 2016;58(2):185-194. doi: 10.1097/JOM.0000000000000592.

Principles and Practice of Yoga Therapy: A Complete Guide for Learning and Practice of Yoga Therapy

. Chennai, India: VHP Publications; 2012.

Heeter C, Lehto RH, Allbritton M, Day T, Wiseman M. Effects of a technology-assisted meditation program on healthcare providers’ interoceptive awareness, compassion fatigue, and burnout. 

 2017;19(4):314-322. doi: 1097/NJH.0000000000000349.

Lehto RH, Heeter C, Allbritton M, Wiseman M. Hospice and palliative care provider experiences with meditation using mobile applications. 

. 2018;45(3):380-388. doi: 10.1188/18.ONF.380-388.

Partner Perspectives

Researchers tested a meditation app that addresses the work stressors of oncology professional healthcare providers. 

Meditation App Benefits Hospice and Palliative Care Clinicians

A diagnosis of primary immunodeficiency as a teenager, and later of autoimmune disease, didn’t discourage Ashley Hay, BSN, RN, from pursuing her dreams. Maintaining a positive attitude helped her circumvent professional roadblocks while managing chronic illness to craft a successful nursing career alongside, and away from, the bedside.

Ashley Hay has always loved writing. When the time came to choose a career path, she initially considered journalism but had been so inspired by stories of caring nurses who had helped her father during his treatment for osteosarcoma and leg amputation that she decided to become an oncology nurse instead. Because she had received immunoglobin therapy on a pediatric oncology infusion unit as a teenager, she believed she could one day care for this population, too.

Hay pursued nursing and acquired experience in various healthcare settings in oncology, including proton therapy, clinical research, chemotherapy, transplant, hematology, wound care, postanes¬thesia recovery, and more.

BALANCING ACT: CAREER AND CHRONIC ILLNESS

Symptom management became challenging, as Hay worked the night shift while pursuing her bachelor of science in nursing, but her passion for the profession and a strong desire to continue learning helped her persevere. She advises nurses with chronic illness to make taking care of themselves their first priority. “Your basic needs must be met first to be able to provide great care,” Hay says.

Over time, the physical demands of nursing took a toll on Hay. With her career in the balance, she asked herself, “How can I possibly continue to use the skills I’ve worked so hard for in a way that my mind would be fulfilled and my body wouldn’t reject?”

One day, Hay came across an article by a nurse freelance writer. Until then, she had never realized her 2 passions, nursing and writing, could coexist. “Once I went into nursing, I had given up on writing,” she says. But then, Hay adds, she realized, “I could combine the expertise I had gained over the years with an ability to educate my peers.”

She admits that when she considered freelance writing, she initially suffered self-doubt: “Could I do it?”

A community of freelance healthcare writers and authors that offers insight, support, and accountability 

A website offering resources and opportunities for networking 

allnurses.com/entrepreneursinnovators-hub

Resources for nursing career options away from the bedside

Upon reflection, she realized she had already ventured into healthcare writing in 2012 while working at Memorial Sloan Kettering Cancer Center in New York City. She had written up results of 

 and presented the report at a meeting of the Oncology Nursing Society. She had received complimentary feedback on her work, and the more she thought about it, the more she believed she could do it.

At the beginning of her freelance writing career, Hay collected data on other nurse writers. She researched and reviewed their writing clients, their rates, and their websites to help create her business plan and develop her website, ahaywriting.com.

Her initial submissions to publications were not accepted, and she felt discouraged but remained determined. Then an unpaid article for allnurses.com, the largest peer-to-peer nursing website, led to her first writing break. “They loved the article and asked to bring me on as a contracted writer,” says Hay.

As her writing business grew, Hay realized she’d need to use her assessment skills in a different way. “Learning basic business skills like invoicing, and creating purchase orders and contracts was an obstacle in the beginning and seemed overwhelming for someone with no business background,” she says.

Hay discovered that the network she had developed with other writers from the Healthcare Marketing Network and through allnurses.com proved to be a wonderful resource for helpful advice. “Ask other people. If I reached out, others were happy to help a novice writer. That’s how I learned what to charge and how to negotiate.”

Hay’s hard work led to a growing portfolio of healthcare writings. During this time, her health required her to reduce her nursing hours. Ultimately, the time came to completely step away from the bedside to fully focus on freelance writing.

The decision was a difficult but necessary one for Hay. Being a freelancer means she has much more flexibility in her schedule to accommodate her medical needs. “It’s wonderful for my business when my calendar gets full, but sometimes my body has other plans for the day,” she says. “I get ahead when I can but take time when I need to, or have to, rest.”

In addition to writing articles, Hay has begun working as an oncology consultant and identifies public speaking as a long-term goal. She is also working on a book that documents the struggles of nurses with chronic illness and hopes to make a difference through sharing their stories. She encourages nurses who have stepped back from their bedside career but still want to use their experience to pursue their life’s passions. “Just go for it. Nurses are very resilient, flexible, intelligent people who have all the skills to do whatever we would like in our careers.”

Maureen L. Bonatch MSN, RN, is a fiction author and a freelance healthcare writer specializing in leadership, careers, and mental health and wellness. She is the owner of CharmedType.com and MaureenBonatch.com.

Feature Story

Ashley Hay, BSN, RN, crafts a successful career away from the bedside.

From Nurse to Freelance Writer

Although placebo use in cancer clinical trials has been rare, it is becoming more common in today’s advanced pharmaceutical environment.

 Some trials have started to incorporate randomization and placebo.

 Placebo-controlled trials are justifiable when they are supported by sound methodologic consideration and when their use does not expose research participants to excessive risk of harm.

 What do you need to know regarding placebo in cancer clinical trials? Below is a look at the use of placebos in oncology practice.

The use of placebos dates back to at least the end of the 18th century.

 After World War II, randomized controlled trials gained in popularity, making the inclusion of placebos more common. A placebo is a pharmaceutically inert substance, often a sugar pill.1 Investigators use placebos to prove a new treatment is effective above and beyond the simple belief in the ability of the drug to cure.

During a trial, one group will be given a placebo, and the other group will receive the new active drug therapy being studied. The results of the outcome of the drug use are then compared between the 2 groups. The placebo-controlled trial is considered the gold standard for testing the efficacy of new treatments in most clinical research areas other than oncology.

During a recent interview with Cancer.Net, Richard L. Schilsky, MD, senior vice president and chief medical officer of the American Society of Clinical Oncology, discussed recent changes in the structure of clinical trials for cancer treatments. In past years, he said, it was not necessary or even possible to use placebos in cancer clinical trials.

A randomized double-blind, placebo-controlled study is considered the benchmark of epidemiologic research.

 Randomly assigning treatment reduces complicating variables.

 In double-blind studies, the participants, the investigators, and the staff do not know which patient is receiving which treatment.

One of the reasons placebos were not used in cancer research is that investigators could easily identify patients randomized to the placebo group based on the change in tumor size.

 Another was related to adverse events (AEs). Many past chemotherapeutic agents caused severe and easily identifiable effects, potentially unmasking randomization of patients to placebo or active treatment groups.

In the interview, Schilsky went on to report that today, many of the newer, targeted drugs slow tumor growth rather than shrinking the tumor, thus allowing placebo use in cancer trials.

 Because visible changes are now more difficult to see, a control group in these trials is beneficial to show whether the stabilization of tumor growth is from the treatment or the natural behavior of the tumor.

The other change Schilsky discussed is related to the pharmacokinetics of the newer cancer treatments. Many of the latest cancer drugs are given by mouth and have fewer AEs, such as fatigue, for which the cause—the cancer itself or the drug&mdash;is difficult to determine.

 So, this study design, once not used in cancer clinical trials, is on the rise.

Schilsky offered this support for the necessity of the advancement of cancer research: “The fastest way to improve access to new cancer treatments for all patients is the timely completion of well-designed, definitive clinical trials that provide evidence of the safety and effectiveness of a new drug and lead to marketing approval.”

 To achieve this goal, the inclusion of placebo control may be necessary in some circumstances.

Ethical concerns about placebos have existed for as long as they have been in use. It is important that the use of placebos be disclosed to all study participants upon entry into a clinical trial.

 Because clinical trials use human subjects, there must be a balance of science, ethics, and human protection.

 When there is no standard treatment, the use of a placebo is typically accepted. However, in placebo-controlled trials, ethical concerns arise when an effective treatment exists.

 If a placebo increases the risk of the control group’s having an adverse outcome, such as death, irreversible illness, disability, or other injuries, it should not be used.

 If a highly effective or potentially curative treatment is available, the use of placebo is considered unethical.

“The bottom line is that there are no ‘ethical considerations’ when placebos are used appropriately in cancer clinical trials,” said Lisa Schulmeister, MN, RN, FAAN, in an interview with 

. “The important thing is that a placebo is not being compared to known effective cancer treatment. They are being used alone in symptom management trials. They’re being used alone when there is no known effective treatment. They’re being used in conjunction with known effective treatment.”

The increased use of placebos in oncology makes it important for nurses to familiarize themselves with how they are used. Patients may have misconceptions about placebos in clinical trials, and it is a nurse’s role to provide education about them. Schulmeister also says that nurses need to reinforce the importance of noting and reporting side effects during a trial. If patients have questions or concerns regarding the use of placebo in a clinical study, nurses should contact the research coordinator or primary investigator for more information and support. They can also refer patients to their informed consent document, which should clearly explain the purpose of the study and any placebo use.

Melissa Mills, BSN, RN, CCM, MHA, is a freelance healthcare writer and owner of the website makingspace.company. She has been a registered nurse for 20 years and is passionate about case management, nursing leadership, and finding the right care for patients in every setting.

Milestones in cancer research and discovery. National Cancer Institute website. cancer.gov/research/progress/250-years-milestones. Published January 21, 2015. Accessed June 14, 2018. 

Placebos in cancer clinical trials. Cancer.Net website. cancer.net/research-and-advocacy/clinical-trials/placebos-cancer-clinical-trials. Published April 2018. Accessed June 8, 2018.

Misra S. Randomized double blind placebo control studies, the “gold standard” in intervention based studies. 

 2012;33(2):131-134. doi: 10.4103%2F0253-7184.102130.

Gupta U, Verma M. Placebo in clinical trials. 

 2013;4(1):49-52. doi: 10.4103/2229-3485.106383.

Millum J, Grady C. The ethics of placebo-controlled trials: methodological justifications. 

 2013;36(2):510-514. doi: 10.1016/j.cct.2013.09.003.

Fast Facts for the Frontline

Why are more oncology trials incorporating placebos today?
 

Exploring the Use of Placebo in Cancer Clinical Trials

 is an increasingly common concern for cancer survivors, affecting their treatment, recovery, quality of life, functional abilities, and long-term survival. About 31% of cancer survivors are obese,

 and that percentage has been steadily increasing for more than 2 decades, with no signs of slowing. Underserved populations, which tend to be minorities and those in rural areas, face a disproportionate burden, with higher rates of cancer and higher mortality. These populations also tend to have higher rates of obesity, creating a challenging environment for providers to address unmet needs and encourage lifestyle modifications.

Karen Meneses, PhD, RN, FAAN, professor and associate dean for research at the University of Alabama at Birmingham (UAB) School of Nursing, studies the intersection of obesity, cancer, and underserved populations. She said about 40% to 60% of the population around her is overweight or obese.

Despite efforts by leading health organizations and individual institutions, there’s still no standard approach to weight management and nutrition for cancer survivors. Nurses are poised to be advocates for patients, incite change, and spur individuals to action.

Research in breast cancer survivors found a 41% increase in all-cause mortality among obese women compared with those of a normal weight.

According to Wendy Demark-Wahnefried, PhD, RD, who studies weight management and patients with cancer and works with Meneses in underserved populations, second cancers represent the fastest-growing cancer diagnoses in the country. Though obesity may not necessarily be identified as the direct cause of death in second cancers, she says, it does increase mortality from comorbidities such as heart disease and diabetes. “We also know that individuals with diabetes have diminished physical functioning,” Demark-Wahnefried, who is professor and Webb Endowed Chair of Nutrition Sciences and associate director, UAB Comprehensive Cancer Center, added.

Meneses said many of the patients she works with are breast cancer survivors who were overweight or obese before their diagnosis. “With the food culture in the South and a preferred self-image that skews toward being a little larger, many of these women struggle through treatment and put on more weight,” she said. Many of her patients come from rural, underserved communities, presenting unique challenges to tackling obesity throughout treatment.

In the United States, about 21% of cancer survivors live in rural areas, where people tend to be poorer, have less access to community programs, and have higher education gaps than those living in urban areas. Low-income minority populations also have higher rates of obesity.

Whether from lacking money or living in food deserts, many underserved populations simply don’t have access to healthy foods. They have more convenient fast-food chains than quality restaurants. And some people are unaware of how to make the most of what they do have available. For instance, urban populations may have more grocery stores or food banks they can learn to use appropriately, while rural areas may be more able to grow their own produce and have access to community gardens or farmers markets.

. “In underserved populations, [people] have access to fast foods, junk food, and grocery stores. Patients tend to put others before themselves and buy food that is convenient or cheaper.”

Smith is currently field medical director in GU Oncology at Pfizer and works periodically at the University of Chicago Medicine as an oncology nurse navigator. She has worked with underserved populations throughout much of her career.

When much of the population is obese, many people don’t see themselves as overweight or obese. They’re concerned about the perceptions of their family and friends if they lose weight. They also may not get the support they need when their loved ones aren’t trying to lose weight or maintain healthy weights themselves.

“Some patients we see worry that if they lose weight, their friends and family would worry too much about what is wrong because families think cancer is associated with massive weight loss,” Meneses said.

Meneses and Smith emphasized that food is deeply personal for many people, representing kinship and community. Someone gets sick? You take food to them. Family or church gathering? Everyone brings food. Cultural traditions can make it hard for patients to follow healthier eating patterns when social functions make it easy to overeat.

Preparation methods get passed down through generations. Frying tends to be cheaper and easier than other methods of cooking. It’s also how many people whom Smith has met were raised to eat. “People cook like Mama used to cook,” she said.

“It’s the only way they know how, and even the kids know how to use the deep fryer to prepare meals when Mom or Dad can’t.”

Pro Tips for Advising Patients about Weight Loss

Karen Meneses, PhD, RN, FAAN, suggests giving survivors who are obese or at risk simple strategies to reduce their weight:

Recommend that they follow free workout videos on YouTube for 15 or 30 minutes of physical activity daily

Teach them about small changes to cooking habits

Suggest better choices at fast-food restaurants

Share healthy recipes that feature affordable ingredients

Suggest they eat more fruits and vegetables

Trust between patients and their providers affects whether those patients will be willing to accept messages about the need to address obesity. Meneses has found challenges in helping Hispanic women, who in her experience tend to defer to their husbands’ opinions and have different family dynamics. With this population, a nurse or a dietitian may need to engage a woman’s husband and other family members to explain why weight loss is important and how it contributes to recovery and survival.

Smith finds that in Chicago, African American patients are sometimes wary of accepting messages from medical staff who don’t look like them. “Patients don’t always feel they can trust the information they are being told because they can’t relate specifically to some of the individuals sharing that information with them,” she said. Smith, who is also African American, makes a point to connect with her patients, sharing her own or her family’s struggles to build trust and inspire change.

“Although nursing is the most trusted profession, it’s still hard to find diversity,” she said. “It’s important to have conversations and relate to patients personally.”

Obesity leads to a host of problems for cancer survivors, but the good news is, there’s a lot that patients can do to reduce their risks. Obesity is the second-leading preventable cause of cancer, and lifestyle modifications do make a difference.

In one study, cancer survivors who had more physical activity had a 37% lower risk of dying from cancer than those who were less active. In another, weight management interventions improved metabolic health and decreased inflammation. Weight loss of just 3% to 5% lowers the risk of diabetes and cardiovascular disease.

 Knowing that interventions work, nurses next need to figure out how to spur patients to take action.

Nurses are in a role to inspire change in their patients and organizations. Financial limitations may make accessing supportive services difficult for some survivors. But many communities around the country have coordinated outreach programs. And exercise and healthy eating can be affordable; individuals just need motivation more than anything.

“Establishing principles of self-management and empowerment are where we have to go,” Meneses said. “More burden is being placed on the survivor and family.”

The first thing nurses can do is simply deliver the message about food, weight, and exercise in culturally relevant ways, and do it early. “The easiest way to intervene is at the point of diagnosis,” Demark-Wahnefried said. “Tell people that some treatments increase the chance of becoming overweight or obese.”

The American Society of Clinical Oncology (ASCO) and other groups recommend talking about weight management, including diet and exercise, with patients, starting with the basics and not assuming patients know the risks of being overweight.

A 2017 ASCO opinion survey found that only 31% of Americans realized that obesity was a risk factor for cancer.

Nurses can begin the conversation by showing the patient a body mass index chart and explaining the benefits to obese people of losing even 3% of their body weight. Educating survivors on the importance of building and maintaining muscle to lessen weight gain could halt some preventable consequences.

Delivering the message to underserved populations can be challenging. “We have to introduce changes in diet and physical activity slowly and repeat the message,” Meneses said. That’s why it’s all the more important to start at diagnosis.

Emphasize what they can control, Smith said. They can control what they eat, how they prepare meals, and how much they move around. Encourage them to use what they have at home for exercise, such as canned goods as weights or videos on their smartphones.

Meneses, Demark-Wahnefried, and Smith all emphasized the importance of nurses’ modeling positive behaviors and maintaining healthy weights. “Delivering a message about weight can be uncomfortable and harder if you’re insecure about your own weight,” Demark-Wahnefried said. “But I’ve seen a new generation of nurses becoming more health conscious and leaner.”

“I was overweight a few years ago,” Smith said. “I didn’t want to repeat my family history, so I changed my habits.” She’s now able to share that journey with patients as well.

Addressing obesity and cancer is complicated and multifaceted. Results from research have shown that providers have gaps in their knowledge of nutrition and physical activity recommendations, making it harder to deliver these messages.

 Not to mention the time involved in talking about health and following up, along with cancer and survivorship care. Nurses don’t have to do it alone. Registered dietitians and nutritionists have deep knowledge of food and health. Refer patients to these experts, and tell the dietitians about a patient’s care plan. Is a patient on a medication that will likely cause weight gain? Is the patient at risk of losing muscle mass that could cause weight gain? Working together will give patients the best information and strategies for self-management.

Despite more recognition of the problem of obesity, coordinated, national efforts are lacking. Meneses and her team at UAB have worked on community programs that have seen success, focusing mostly on empowering patients and educating them on ways to improve self-management skills, including:

Cover Story

Overweight survivors in rural and minority populations need nurses on their side.

Obesity, Cancer, and the Underserved

, also called scalp hypothermia and cold cap therapy, was introduced in the late 1970s, and many had high hopes for its success. However, its effectiveness in preventing hair loss varied by the type of chemotherapy administered, and because of concerns about the potential for scalp metastasis, scalp cooling quickly fell away. Now, it’s back and commonly used in clinical practice. Scalp cooling constricts blood vessels in the scalp, thereby reducing blood flow to the hair follicles and limiting the amount of chemotherapy that reaches the follicles.

There are 2 types of scalp cooling available in the United States. Manual cold caps have gel or fluid-filled compartments that require chilling/freezing and are placed on the patient’s head about an hour before chemotherapy. The caps are changed periodically during the infusion (usually every 15-30 minutes) and worn for 90 to 120 minutes afterward. Caps, supplies, and rolling coolers are rented to patients, and shipped or delivered to the patient’s home or treatment facility. Machine-based scalp cooling systems consist of a cap connected to a device that circulates coolant through the cap. These systems provide automated continuous cooling at a set temperature throughout the chemotherapy treatment. Some models have 2 independently-controlled continuous cooling systems that enable simultaneous treatment of 2 patients, and the system can be easily detached if a patient needs to use the restroom.

Two recent US prospective studies of scalp cooling systems support the safety of the practice. Adverse events were minor (grade 1 or 2) and included headache, nausea, chills, dizziness, skin pain, skin ulceration, dry skin, sinus pain, paresthesia, and pruritus.

In one of the US studies, 101 women used a machine-based cooling system and were followed for a month after the last chemotherapy cycle; 67 of the women (66.3%) lost less than half of their hair. In comparison, 16 women (100%) in the control group lost more than half of their hair. Success was documented in 83.3% of women receiving docetaxel and carboplatin, 60.2% of those treated with docetaxel and cyclophosphamide, and 83.3% treated with a taxane alone.

 In the second study, conducted at 7 US sites, successful hair preservation occurred in 50.5% of women who underwent machine-based scalp cooling compared with none of the women in the control group who did not receive scalp cooling. About a third of the 142 women received anthracycline-based chemotherapy, and 64% received taxane-based chemotherapy.

In both studies, there was variability in the rate of hair preservation, which may have been due to improper fit of the cap, type of chemotherapy (less hair loss was observed with taxane-based treatment than with anthracycline-based treatment), and patient characteristics such as pretreatment hair thickness and texture.

Chemotherapy-induced hair loss can be a distressing effect of cancer treatment, so scalp cooling should be discussed with concerned patients. The FDA approved machinebased scalp cooling for use in women with breast cancer in 2015, and in July 2017, expanded its approval for use in all patients with solid tumors.

Studies of scalp cooling have excluded patients with hematologic malignancies because of concerns about reducing treatment efficacy. Scalp cooling should not be used by patients with cold agglutinin disease, cryoglobulinemia, and cold-induced migraines because of the potential to exacerbate these conditions through prolonged exposure to cold temperatures.

Manual scalp cooling systems rent for $325 to $500 per month. A full course of manual or machine-based scalp cooling during adjuvant chemotherapy for breast cancer costs $1500 to $3000.

 Some insurance companies may cover scalp cooling treatment, and patients can apply for assistance from the nonprofit organization HairToStay (hairtostay.org).

A practical issue related to scalp cooling is how to incorporate it into the workflow of an infusion center. The prechemotherapy cooling period could coincide with administration of premedications, and manual posttreatment scalp cooling could occur in another area, such as a waiting room.

 However, machine-based cooling is more difficult to relocate to another area and may not be possible if 2 patients are using 1 machine simultaneously.

Scalp cooling is now approved for use with men as well as women, so scalp cooling may be an option for men with solid tumors who are concerned about hair loss. However, all patients considering scalp cooling need to know that data suggest it reduces but does not entirely prevent hair loss, so they should expect some degree of loss to occur. Another consideration is that there are limited follow-up data, so there is some concern about the potential for scalp metastasis. In fact, investigators planned routine follow-up visits for the women enrolled in the multisite trial for 5 years after the study to further assess safety (time and site of first recurrence) and overall survival.

FDA clears wider use of cooling cap to reduce hair loss during chemotherapy. National Cancer Institute website. cancer.gov/news-events/cancer-currents-blog/2017/fda-cooling-cap-chemotherapy. Published July 21, 2017. Accessed April 19, 2018.

Rugo HS, Klein P, Melin SA, et al. Association between use of a scalp cooling device and alopecia after chemotherapy for breast cancer. 

. 2017;317(6):606-614. doi:10.1001/jama.2016.21038.

Nangia J, Wang T, Osborne C, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: The SCALP randomized clinical trial. 

 2017;317(6):596-605. doi: 10.1001/jama.2016.2093.

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy [news release]. Silver Spring, MD: FDA; July 3, 2017. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565599.htm. Accessed April 19, 2018.

Kruse M, Abraham J. Management of chemotherapy-induced alopecia with scalp cooling. 

 2018;14(3):149-154. doi: 10.1200/JOP.17.00038.

Nurse's Notes

Scalp cooling helps reduce hair loss from chemotherapy.

Ahead of the Game with Scalp Cooling

Investigators are hopeful that CMB305, a vaccine that boosts the immune response to tumor cells expressing the antigen NY-ESO-1, can improve survival outcomes for patients with synovial sarcoma, a rare cancer that develops in the arms and legs and affects about 800 individuals in the United States each year.

After patients with synovial sarcoma stop chemotherapy treatment because of toxicities, their disease often progresses. The clinicians can often re-treat with chemotherapy, but as a result of the toxicities, this is not always an option, and there aren’t agents available for subsequent lines of therapy.

CMB305 combines 2 mechanisms of action in 1 vaccine targeting the antigen NY-ESO-1. The prime component is an engineered lentiviral vector that binds to dendritic cells (DCs), causing them to express NY-ESO-1, thereby boosting the immune response against NY-ESO-1—expressing tumor cells.

 The second component of the vaccine, G305, is a toll-like receptor 4 (TLR4) agonist, which also boosts the immune system. G305 binds to TLR4 on immune cells, including DCs, and induces an NY-ESO-1—specific antibody response,

 impeding tumor cell proliferation and survival.

“It’s the combination of these 2 things [that] can make [CMB305] very potent, [prompting] the immune system to recognize and want to go after cells that have NY-ESO-1 protein,” said William B. Tap, MD, chief, Sarcoma Medical Oncology Service, Memorial Sloan Kettering Cancer Center.

In the phase III Synovate study, CMB305 will be tested as maintenance monotherapy in patients with locally advanced, unresectable, or metastatic synovial sarcoma after initial treatment with chemotherapy.

Progression-free and overall survival as the coprimary endpoints will be assessed. Secondary endpoints will include overall response rate, duration of response, and safety and tolerability.

Investigators seek to enroll approximately 248 patients who have achieved stable disease and will randomize them to CMB305 or a placebo.

 Eligible participants must have expression of the NY-ESO-1 surface protein, which is commonly found in synovial sarcoma tumors. The Synovate study is accepting participants as young as 12 years to include in this patient population.

Immune Design. Harnessing the immune system to fight cancer. ir.immunedesign.com/static-files/cdf2d12b-46d6-4972-b99c-0a30b07e9ddb. Published April 26, 2018. Accessed May 22, 2018.

NCI drug dictionary: immunotherapeutic combination product CMB305. National Cancer Institute website. cancer.gov/publications/dictionaries/cancer-drug/def/immunotherapeutic-combination-product-cmb305. Accessed May 22, 2018.

Clinical Trials in Progress

Investigators are hopeful that CMB305, a vaccine that boosts the immune response to tumor cells expressing the antigen NY-ESO-1, can improve survival outcomes for patients with synovial sarcoma.

Novel Cancer Vaccine May Improve Survival in Synovial Sarcoma

Two randomized phase III clinical trials, ASTRAL-2 (NCT02920008) and ASTRAL-3 (NCT02907359), are designed to determine whether guadecitabine (SGI-110), a potent second-generation hypomethylating agent, could answer unmet medical needs for patients with certain types of blood cancer.

Patients with relapsed/refractory acute myeloid leukemia (AML) have limited options for treatment, especially if they are not candidates for hematopoietic cell transplant or do not have targetable genetic mutations. Individuals with a myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) face a similar challenge, and most do not respond to high-dose chemotherapy, which is the first line of therapy, said investigator Guillermo Garcia-Manero, MD, deputy chair, translational research, Department of Leukemia, The University of Texas MD Anderson Cancer Center.

Data suggest second-generation hypomethylating agents such as guadecitabine may in part overcome resistance to hypomethylating drugs such as azacitidine or decitabine, he added. Guadecitabine inhibits DNA methyltransferase, a family of enzymes that catalyze DNA methylation and regulate many normal cellular processes. Aberrant DNA methylation is one of the mechanisms that result in inactivation of tumor suppressor genes, leading to genomic instability, increased cellular proliferation, decreased apoptosis, and increased metastasis. One effect of guadecitabine’s reversing the aberrant hypomethylation is the upregulation of tumor-associated antigens. It can also sensitize tumor cells to other anticancer agents or resensitize resistant cancer cells to chemotherapeutics.

Two randomized phase III clinical trials are designed to determine whether guadecitabine (SGI-110), a potent second-generation hypomethylating agent, could answer unmet medical needs for patients with certain types of blood cancer.

August 2018