Elizabeth Whittington

Soy has been touted as a wonder food, as it’s high in fiber, potassium and protein. It’s often used as a meat substitute, which could ultimately lower overall cancer risk in individuals who use it to replace their red meat intake. The low incidence of breast cancer in cultures with high soy consumption, particularly in Asian countries, also has led to the theory that soy lowers breast cancer risk.

But a diet high in soy has also been associated with cancer risk because it contains isoflavones, a type of phytoestrogen that has a similar structure to estrogen and binds to the estrogen receptor. Might women with a high risk of breast cancer or a past diagnosis of estrogen-positive breast cancers increase their risk by consuming large amounts of soy?

The potential association between soy and breast cancer initially came to light in the 1990s after a rodent study showed an increase in hormone-positive breast cancer incidence after rats were fed high doses of isoflavones. It seemed to make sense that foods high in phytoestrogens could impact the growth of breast cancer cells fueled by estrogen.

But experts now say it’s a large leap to go from the effects of high supplemental doses of a soy compound in rats to an effect in humans.

If anything, recent research has shown that it is associated with a lower risk of breast cancer, and for women who have had breast cancer, with a lower risk of recurrence, says Peggy Mancini, a clinical dietitian at City of Hope in Duarte, California.

A large-scale study found that women who consumed natural sources of soy had a lower risk of breast cancer than individuals who did not consume soy. The study, which was published in 2014 in the 

, found that of the nearly 10,000 women surveyed, those who consumed soy after a breast cancer diagnosis had a 25 percent lower risk of recurrence after about seven years. Other evidence points to a reduced cancer risk if soy is consumed during childhood and adolescence. Additional findings have shown that certain dietary factors, including soy consumption, decreased the risk of death from all causes in breast cancer survivors and possibly survivors of other cancers, according to Marjorie L. McCullough, strategic director of nutritional epidemiology for the American Cancer Society.

Finally, other studies have found additional health effects, including cardiovascular benefit, a lower risk of colon cancer and decreased PSA levels in prostate cancer survivors. There has not been a confirmed association, and studies have yielded mixed results, but soy may also alleviate symptoms of menopause, including hot flashes.

Experts recommend moderate soy consumption, as with most foods and beverages. A diet high in soy could include soy beans, tofu, tempeh, edamame, soy yogurt and soy milk.

In fact, Mancini recommends soy milk over other milk alternatives. “It’s closer to animal milk than are almond or rice milk, which don’t have the protein soy milk has,” she says.

McCullough, whose research has focused on the role of dietary factors in relation to cancer risk, emphasizes that people should consume their soy through whole foods, not supplements.

“So far, in the studies in humans, observational studies, people were eating soy foods and some were taking supplements,” although not enough to sufficiently draw conclusions about the pros and cons of supplementation, she says. “We just don’t have the data. At the American Cancer Society, we don’t recommend that people take (soy) supplements because we just don’t have the evidence that it’s safe.

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Moderate consumption of soy-based foods may lower the risk of breast cancer or recurrence.

The Skinny on Soy

With cancer treatment being delivered more in an outpatient setting, the burden of home healthcare has shifted more to family caregivers.

Family caregivers are no longer just providing custodial care, but more professional care, such as monitoring for potential adverse events, scheduling oral therapy, keeping up with equipment, and managing treatment adherence.

Patricia Geddie, MS, CNS, AOCNS, a clinical nurse specialist at Orlando Health, says there is no universal measure for nurses to assess family caregiver knowledge of cancer-related symptoms. In a past study that assessed caregiver knowledge of pain management, individuals reported that most of their caregiving skills were learned through trial and error and that more assistance from the medical team would be welcome.

In regards to two specific symptoms—fever and dehydration&mdash;caregivers may not be knowledgeable enough to know when action is needed, such as calling the medical team or heading straight to the emergency department.

“Seems like in our current healthcare environment, we depend on the family and the patient to call us versus us being proactive and calling them before they have the need and to anticipate their needs,” Geddie says.

"Unfortunately, not all family members are very knowledgeable or skilled to manage those side effects and unfortunately, it ends up in a visit to the ED or an unplanned hospital admission.”

Geddie developed The Nursing Assessment of Family Caregiver Knowledge and Action Tool (NAFCKAT) to help identify a caregiver’s baseline knowledge about potential side effects and to personalize the educational material for the patient and caregiver. Geddie presented the data April 25 at the 40

 Annual Congress of the Oncology Nursing Society.

The tool was developed and evaluated in a three-step process, Geddie explained. She researched and developed the format of the questionnaire tool, which was followed up with a reliability study conducted with a group of oncology clinic nurses. Lastly, a validity study of family caregiver groups was conducted, which included factors such as education, gender, prior caregiving experience, and prior cancer experience.

Included in the 10-minute interview were questions geared toward the lay audience, she says, such as: What would a fever look like to you? What would be the appearance of a person who had a fever? How many days would having a fever be a concern? What numbers on a thermometer would concern you? How many times in one day would vomiting or diarrhea concern you?

Not surprisingly, female caregivers had a higher baseline knowledge of fever symptoms than their male counterparts, possibly because of their history of family caregiving, she says. Education levels also played a factor in having a higher baseline knowledge. Nearly all caregivers surveyed had no prior cancer experience.

Almost half of the total sample of caregivers were found to have a fairly high level of knowledge and plan of action for fever and dehydration symptoms, two very common but potentially serious side effects.

“What I found was the fever can be recognized fairly easily,” she says. “And fever is one of the top reasons why some of our cancer patients get admitted to the hospital or emergency room.”

Dehydration, which can be caused by vomiting and diarrhea, is a little more complex, she says, because it’s more difficult to recognize early. Having caregivers diagnose dehydration before it reaches the point of decreased skin turgor and low and dark urine output requires specific education. 

“There is no real standard way to deliver that information, and they are usually under stress when they are receiving that information,” Geddie says. “Sometimes it is just a handout, sometimes it can be a little class. But again, how much can that person retain?”

She encourages nurses to begin with learning how much the caregiver and patient already know; assessing their baseline knowledge will allow the nurse to know what to build on during the teaching moment.

“[W]e’re making assumptions if we’re just telling them about side effects and symptom management,” Geddie says. “We’re assuming they already know certain things and perhaps we haven’t assessed their current baseline.”

Geddie hopes her work will eventually be used in the clinic. She envisions the process will help other nurses put together an individualized educational plan for caregivers, but also will determine ongoing follow-up and the frequency of that follow-up. It’s also important to consider that the caregiver knowledge and needs may change over time.

“Maybe they need to be called every day, once a week; maybe there needs to be a referral to home care or other community resources if possible,” she says.

As Healthcare Shifts to Caregivers, Knowledge Matters

Insomnia, restless leg syndrome, sleep apnea, and other sleep issues often affect quality of life in cancer patients, their caregivers, and survivors. Unfortunately, sleep complaints can often be overlooked by the medical staff or not mentioned by the patient.

Understanding and addressing sleep issues for those affected by cancer is the focus of studies presented at this year’s ONS 40th Annual Congress, including one by Patricia Carter, PhD, RN, CNS, and colleagues sharing the results of a clinic-based behavioral sleep intervention aimed at both patients 

Carter explained that sleep complaints are very often not addressed by healthcare professionals because they often are more focused on symptoms that they feel confident in treating, such as nausea, fatigue, and weight loss.

However, lack of sleep or lack of quality sleep can affect a patient’s memory, mood, immunity, and pain and result in poorer quality of life, which is why medical professionals should broach the conversation around sleep issues and hygiene.

“Talking with patients and caregivers about sleep is important because patients and caregivers often accept that poor sleep is a 'price to pay' for having and being treated for cancer, when, in fact, we have several empirically supported therapies that can help to improve sleep quality for patients and caregivers,” Carter says in an pre-conference interview with 

Carter, an associate professor at the University of Texas at Austin School of Nursing, specializes in behavioral sleep medicine not only for patients, but also caregivers.

Carter and colleagues presented a small, four-week study at ONS which found, not surprisingly, that both patients and caregivers reported similar levels of sleep disturbance, with nearly half reporting symptoms of insomnia.

“There are a number of studies that have explored the effectiveness of behavioral sleep therapies in patients or caregivers; however, there were no studies that explored providing these therapies to both the patient and the caregiver at the same time,” Carter noted.

“We hypothesized that treating both members of the dyad would offer support for the behavioral changes needed to improve sleep. Sort of a 'sleep buddy' would help you keep your sleep goals, like an 'exercise buddy' helps you to keep your physical activity goals.”

The researchers developed an hour-long informational discussion with two short follow-ups that could be given during the patient’s infusion therapy, which encouraged the patient and caregiver to improve their sleep together. Information was provided to the duo on stimulus control, sleep hygiene, relaxation techniques, and other cognitive behavioral therapy to increase quality sleep.

“We also observed a synergistic effect of providing the therapy to both partners at the same time in that they were able to plan and coordinate their sleep goals to support each other,” Carter continued. She also noted that the results showed that it is possible to provide behavior sleep therapies to both patient and caregivers during chemotherapy with minimal disruption to the workflow while maximizing the learning opportunity.

“It is always a good time to talk about sleep quality and ways to improve it,” Carter says. “The conversations should happen throughout the treatment and survivorship care… Sleep quality can impact both physical and psychological health and research is beginning to support the relationships between sleep quality and treatment effectiveness.”

Sleep Disorders in Breast Cancer Survivors

Not all sleep complaints point to a disorder; however, research is lacking on sleep complaints in breast cancer survivors in the context of possible sleep disorders. This information, according to researchers from Indiana University (IU), is needed for medical staff to offer treatment options, including referring patients to a specialist or suggesting cognitive—behavioral treatment, such as improving sleep hygiene and behaviors.

Julie Otte, RN, PhD, OCN, of the IU School of Nursing, and colleagues are presenting data at ONS that show how sleep complaints in breast cancer survivors may be more common than initially thought and that comprehensive evaluations of sleep complaints may signal a need for patients to be referred to a specialist.

The researchers conducted patient interviews and questionnaires, and analyzed biomarker data from a sample of 38 breast cancer survivors. All participants were postmenopausal with a mean age of 58 years. The sample group was composed of African-American and Caucasian women.

Although preliminary, the resulting evidence points to a very large percentage of survivors who have sleep complaints that should be referred to a sleep specialist for further evaluation and treatment. The IU researchers’ data revealed, for example, that 97 percent of participants had symptoms of a sleep disorder, including insomnia (97 percent), sleep apnea (71 percent), and restless leg syndrome (53 percent), with a majority of participants having more than one sleep disorder.

Researchers found that integrating basic screening questions during clinic visits helps nursing staff identify potential problems that could be used to triage patients needing specialist referrals. 

Sleep: An Unmet Need in Patients, Survivors, and Caregivers

 While clinical trials remain a treatment option and play a significant role in furthering cancer research in treatment, symptom management, and survivorship, less than 5 percent of patients participate in them, and 40 percent of patients report that they do not understand the idea of a clinical trial.

Patients who seek out clinical trials often rely on their medical team, primarily their oncology nurses, to help them navigate the process, including searching for a trial, understanding participation criteria, and enrolling in one.

“If patients aren’t provided information on clinical trials when they are considering their treatment options, they aren’t being provided with all of the options available to them,” says Kandie Dempsey, MS, RN, OCN, director of cancer research at Helen F. Graham Cancer Center & Research Institute at Christiana Care Health System in Newark, Delaware. It’s important for oncology nurses to understand how they can help their patients learn more about clinical trials, where to find them, understand them, and ask questions about enrollment, she explained.

At the 40th Annual ONS Congress, Dempsey and Rebecca J. Williams, PharmD, MPH, assistant director of the ClinicalTrials.gov site, delivered information on how nurses can  educate themselves and their patients about the clinical trial process, primarily how to use and search for trials on the clinical trial database. Clinicaltrials.gov, hosted by NIH, is the number-one registry site for clinical trials. It includes both federally funded and privately supported studies, featuring nearly 200,000 clinical trials in 109 countries.

Dempsey says that while that percentage of patient participation hasn’t increased, she has noticed an increase in patients asking about specific clinical trial protocols.

“What we’re seeing is that patients and their families have a greater awareness of clinical trials,” Dempsey says, which easily corresponds to an increase in discussion with their nurse about potential enrollment and participation.

“Twenty percent of all adult cancer patients are medically eligible, but only 3 to 5 percent take part, and it’s even lower for ethnic and racial minorities,” Dempsey says. “I think with the education of the ClinicalTrials.gov site to patients—and also to nurses and the people in the healthcare field&mdash; it’s going to boost that rate of participation.”

In her own facility at Christiana Care, Dempsey says 22 percent of eligible patients are enrolled in clinical trials, including those who have been typically underserved and patients older than 65 years. “We credit that to our nurse navigators, as well as our clinical trial nurses and physicians,” she says.

Dempsey encourages nurses to become familiar with the ClinicalTrials.gov website in anticipation of patient questions. Some of the features of the site she emphasized include filtering by disease type, phase of the study, and location. Inclusion and exclusion criteria, along with contact information for the study investigator and clinical trial sites, can also be important information when helping a patient decide on clinical trial participation.

In 2008, ClinicalTrials.gov launched its results database, which by law, requires results of a study to be published no later than one year after completion. Healthcare professionals and patients interested in specific studies can sign up for automatic updates for ongoing trials. For researchers, the publication database, which includes both positive and negative study results, also helps to reduce unnecessary duplication of trials.

Numerous resources are available to get the most out of the federal website, including online training on searching for clinical trials, downloading search results, RSS feeds, and finding study results, which can be accessed at 

Dempsey says that educating patients on the clinical trial process and how research is conducted can also help patients in evaluating websites when they and their families are looking for information about their cancer and treatment.

“Our key motto is research cures cancer, and education helps to overcome those challenges nurses face,” she says.

While clinical trials remain a treatment option and play a significant role in furthering cancer research in treatment, symptom management and survivorship, less than 5 percent of patients participate in them, and 40 percent of patients report that they do not understand the idea of a clinical trial.

Elizabeth Whittington

The Skinny on Soy

As Healthcare Shifts to Caregivers, Knowledge Matters

Sleep: An Unmet Need in Patients, Survivors, and Caregivers

Clinical Trial Awareness, Enrollment Increasing

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