For patients with cancer, moving through the phases of diagnosis, treatment, and survivorship can be more than a little daunting. The process can seem like a different world, with a whole new language. Personalized treatments, molecular profiling, and immunotherapies have led to advances in treatment, but they also add a layer of complexity at a time when patients and their loved ones are feeling terrified and overwhelmed.

Enter the nurse navigator, a certified RN with navigation training tailored to a specific type of cancer. The nurse navigator’s role is to empower patients and families by eliminating barriers to care, providing education about their specific cancer, available treatments and clinical trials, as well informing them how to find support, such as physical and psychosocial therapy and financial and transportation resources.

Sarah Cannon, the Cancer Institute of HCA Healthcare, has built a flagship navigation program to serve its cancer programs across the nation. The program has seen tremendous growth—from just 5 nurse navigators in 2011 to 200 today. The number one goal of the navigation program, explained Crystal Dugger, MBA, MSN, RN, assistant vice president of clinical operations at Sarah Cannon, “is to help patients stay compliant with the treatment plan.”

“Nurse navigators are the point person for the patient throughout the entire continuum of care,” she continued. And, nurse navigators are not there just for the patients. At Sarah Cannon, navigators also coordinate office visits, streamline communication among other members of the healthcare team, and organize multidisciplinary team conferences. With a process that has as many moving parts as cancer care, the nurse navigator can function as a conductor, ensuring that all departments know how to work with one another in the most efficient and effective way.

“Nurse navigators are the point person for the patient throughout the entire continuum of care.”

The impact of the program can be seen in many ways, but especially in the patient experience. As just 1 example, Dugger mentioned a patient who had been diagnosed with breast cancer 8 years ago, before the navigation program was in place. Recently, that same patient had a recurrence and was given a nurse navigator. “She could not stop talking about the difference in the experience that she had from the first time compared to the second time,” Dugger said.

Dugger attributes much of the success of Sarah Cannon’s navigation program to the creation of oncology pathways— guided by physicians and based on tumor type and stage&mdash;that help ensure seamless care across the cancer journey for both patients and providers. These pathways help to standardize the training and role of the nurse navigator, with an eye toward achieving critical quality metrics and optimal patient outcomes throughout the health system.

The Sarah Cannon program assigns a nurse navigator to the patient at the time of diagnosis. In turn, the navigator walks with the patient through every step of the cancer journey: diagnosis, genetic testing, treatment, palliative, and/or supportive care.

Nurse navigators at Sarah Cannon also keep the patient’s own specific goals in mind. “The navigator’s job is to ensure that the voice [of the patient] is heard in our multidisciplinary conferences, when providers are creating the treatment options for the patient.” Dugger recalled a patient who was a concert pianist, but the standard chemotherapy was likely to cause neuropathy, or severe numbness in the fingertips, a side effect that would have a tremendously negative impact on that patient’s livelihood. Survival statistics were not quite as good with another chemotherapy option, but that therapy offered a lower neuropathy risk, an option the patient preferred. Without the nurse navigator advocating on the patient’s behalf, this risk may have been missed.

For other institutions seeking to start or improve their own navigation programs, Dugger urges starting with a vision: “What are you trying to accomplish? What is the goal you’re trying to reach?” It is also necessary to have other programs and departments fully on board: “You need to make sure you have physician and administrative alignment.”

Successful navigation programs ultimately depend on a workable business model. “We have to make sure that we’re being impactful within the budget,” Dugger stressed. For Sarah Cannon, this meant measuring patient satisfaction and retention at the facility. Although nurses can sometimes be uneasy focusing on financial aspects, they’re important for creating a sustainable program.

To facilitate demonstration of the navigation program’s value, Sarah Cannon’s proprietary iNavigate data collection software captures key metrics such as timeliness to first treatment, patient satisfaction, and navigator retention, which generates a scorecard that captures all data into one report.

“At the end of the day, our goal is to help more patients. You’re going to do that by showing a good business model, so you can get resources, grow your program, and show improvement.”

For nurses who are unfamiliar with quality and financial metrics or may be uncomfortable with this line of thinking, Dugger urges them to get more involved with leadership. “Nurses have to start talking from the perspective of both sides of the business. We have to get nurses thinking that way,” she said.

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Nurse navigators at Sarah Cannon use oncology pathways to help ensure patient access to seamless care across the cancer continuum.

Removing Barriers to Improve Care

Myelodysplastic syndromes (MDS) are rare, which can make them difficult to study. The biggest challenge is finding enough patients to enroll in clinical trials that could help to advance treatment. But the Aplastic Anemia and Myelodysplastic Syndrome International Foundation (AAMDSIF), a nonprofit organization, wants to change this by providing patients and patient data to support research. One of its efforts in this area is the MDS Clinical Research Consortium.

, Rami Komrokji, MD, a hematologist at Moffitt Cancer Center in Tampa, Florida, discusses the advances that have been made in MDS in the past few years, as well as the MDS Clinical Research Consortium and its importance.

: What progress has been made in the field of MDS in the last few years?

: There have been several discoveries that led to better understanding of the disease and its biology. Hopefully this can translate into improving patient care and finding new treatments.

The use of molecular testing can help us in deciding, or tailoring, the treatment. There are also some new treatments on the horizon based on some of the molecular targets of testing that are being conducted. 

Advances have also been made in the biology of the disease and our understanding of MDS. We've made huge progress in understanding what occurs in MDS, what are the gene mutations that are acquired in this disease, the role of the bone marrow microenvironment and inflammation in developing MDS.

Also, risk stratification for patients with MDS is a crucial step for patient management. How do we risk stratify the disease? Once we establish a diagnosis for patients, we try to gauge the risk of the disease  because we tailor therapy based on that, such as recommending allogeneic stem cell transplant for patients. An accurate risk assessment for the disease or certification is important for the patient and their families. It gives them prognostic information. It's also important for the physicians because we decide on our therapies based on the disease risk.

In MDS, there is an unmet need for patient treatments. We've made some progress with current medications like azacitidine (Vidaza), decitabine (Dacogen), lenalidomide (Revlimid). We consider transplant as a curative option for patients with high-risk disease. Those are the options we currently use. Other than transplant, most of the treatment options are not curative. They work and patients can derive benefit in terms of survival and quality of life, but at some point they stop working. We always are in a need for next treatments.

Over the last few years, we started to understand more about the biology of the disease and found certain genetic abnormalities that hopefully we can target. There are several trials with promising medications looking at this concept.

For example, there is a study that just finished, called the MEDALIST study, which tests a drug called luspatercept, which is injected every three weeks for patients with lower-risk MDS, but need transfusions on a regular basis. In the early phases, phase 1 and 2, this drug showed promising results and is now finishing the phase 3 study. If that study is positive, then this drug could be approved and available for patients. Luspatercept works in certain subsets of patients with MDS, particularly those who have ring sideroblasts or a certain gene splicing mutations, SF3B1 mutation.

Other studies are testing drugs that can target the IDH2 mutation. They have been tested in leukemias and in subsets of patients with MDS.

A lot of the new medications have the same theme, targeting those somatic mutations that are common in MDS. We call them splicing mutations. There are drugs that are known as splicing inhibitors that are going into the early phases of testing in MDS.

There is also a subset of patients with MDS who have a gene mutation called p53. This is a protein or the brake on the cycle. If it's abnormal or mutated, patients tend to have more aggressive disease. With this mutation patients usually respond to available therapies early on, but then the disease progresses after that. We are trying to also develop medications that target that p53 mutation or at least restore its function to control the aggressiveness of the disease. 

There are different, new modalities of treatment. Most of them have the theme that they are going after certain molecular targets, which is something new. In the past, most of the studies of MDS would include a heterogeneous group of patients, without really knowing their biology. Now, the treatments could be based on that underlying biology for the disease and we hope that some of those studies will lead to approvals of drugs in the near future.

Can you talk about the MDS Clinical Research Consortium?

The MDS Clinical Research Consortium is supported by the Evans Foundation for MDS with a generous grant. The AAMDSIF serves as the coordinator for the consortium. The foundation is our link with patients.

The consortium is a collaboration between six large institutions that see a high volume of MDS cases, including Moffitt Cancer Center, MD Anderson Cancer Center, Cleveland Clinic Cancer Institute, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dana-Farber Cancer Institute and Weill Medical College of Cornell University.

The idea is to try to get clinical trials available for patients in different areas and get the trials conducted quickly. That way, if the drug seems promising, we'll be able to push them through development in a faster way.

Typically, MDS studies are very difficult to do at the single-institution level. There are similar consortiums in Europe for MDS where they conduct studies in collaborative fashions like this. This is really the main idea of the consortium, to try to conduct clinical trials of agents that are promising early on, during phase 1/2 development, to be able to get the drugs for patients in phase 3 in a faster way.

Also, through the consortium, we have large datasets of patients, databases that are seen at those institutions so we've been able to collaborate on those data and answer some questions that could not be looked at in clinical trials. For example, the response criteria we're using for clinical trials, are they valid? What happens to patients when they stop responding to azacitidine? Some important questions that cannot be answered in clinical studies, but when you have large datasets of patients, then you can answer those questions.

We've conducted a few studies so far through the consortium, including the first study in chronic myelomonocytic leukemia (CMML) with the drug called Jakafi (ruxolitinib). Jakafi is a drug approved for myelofibrosis, however, through some work in the consortium, we identified that patients with CMML may be sensitive to the treatment because in CMML they have oversensitivity to a growth factor called GM-CSF, where Jakafi will target. We conducted the first phase of the first study particularly in CMML and the first round of results looked promising. We finished a phase 1/2 study in less than two years, which typically would have taken a single institution six or seven years to finish in this subset of the disease.

We have an important study looking at early treatment versus waiting in patients with lower-risk MDS, looking at different dosing of azacitidine and then randomizing them to decitabine for three days or azacitidine for five days, which is the standard for lower risk. That study will answer two important questions: Is there benefit of early treatment? And, which is the best schedule for high-proliferating agents?

We are also bringing the first study with a drug called APR-246 to target that subset of patients that have the p53 mutation.

Why is it important to collaborate among institutions, both nationally and internationally?

The most important thing is being able to conduct clinical trials in a fast way that can lead to patients getting these medications sooner. Typically, the drug approval process takes many years. The first step of conducting phase 1/2 studies is slow and a single institution, no matter how large the volume of patients they see is, may take two years to run the first phase 1 or phase 2 of the study. A collaboration like this can get some of those studies done in six months, so we know if the drug is promising and we can move it further. We hope with this collaboration we'll be able to shorten the time it takes to get a drug from the early testing to the benefit of patients.

Also, sharing the patient information data gives us the power. Let's say we see 1,000 patients. But, if we collaborate with five or six centers, we'll have data on 6,000 or 7,000 patients, which becomes much more powerful in answering certain questions that we cannot answer in clinical trials.

Rami Komrokji, MD, discusses the advances that have been made in myelodysplastic syndrome MDS in the past few years, as well as the MDS Clinical Research Consortium and its importance.

Looking Ahead for Myelodysplastic Syndrome

With smaller patient populations in rare cancers, it can be difficult to conduct clinical trials. This can make advances in this field rare as well. Rare ovarian cancers are no exception to this trend. 

, David M. Gershenson, MD of University of Texas MD Anderson Cancer Center discusses the treatments available for some of these rare types, as well as what the future could look like.

: Can you tell me a little about the rare types of ovarian cancer and what is important to know about them?

: There are several of the rate types of ovarian cancer: malignant ovarian germ cell tumors, sex cord stromal tumors, and then the rare types of epithelial tumors: ovarian clear cell carcinoma, low-grade serous carcinoma and mucinous epithelial ovarian cancer.

I think one of the main takeaways is that there are challenges and barriers to studying rare ovarian cancer. There are many fewer cases and it's very difficult to conduct clinical trials because there are fewer patients. It sometimes can take a long time to accrue patients on a clinical trial. There is not a lot of federal funding for trials of rare cancers in general, and there's as much emphasis on it. The pharmaceuticals are not that interested, for obvious reasons related to revenue. So there are many challenges in trying to make advances in the study of ovarian cancers that are rare.

Also, some of these rare ovarian cancers have a number of very interesting genetic or genomic abnormalities. Unlike high-grade serous carcinoma which is the most common type, which has many abnormalities that are difficult to treat. These types have fairly specific genomic aberrations that can be, in some cases, treated with targeted agents. I think that the emphasis over the past few years, and in the next decade, will be on targeted agents, combinations of targeted agents, and, in some of these rare tumors, hormonal therapies. For instance, for granulosa cell tumors, a type of sex cord stromal tumor, as well as low-grade serous cancers, these are relevant. There are many different targeted treatments and new treatments that we'd like to study, but again it gets back to the challenges that we have in conducting clinical trials.

What are the current treatment options for a patient with one of these rare ovarian cancers?

It varies. For low-grade serous carcinoma, there have been first generation trials of MEK inhibitors. MEK is a gene that occurs in the MAP kinase pathway and we know that there are mutations of KRAS and BRAF that occur in that pathway. There have been a number of trials of these targeted agents, these MEK inhibitors: one has been completed, three have been done in the second-generation, the last of them is finishing accrual later this year. That's one major area of research.

Another for low-grade serous carcinoma is hormonal therapies. We know that low-grade serous carcinoma has many common features with ER+ breast cancer. We are studying aromatase inhibitors in upcoming trials in the neoadjuvant setting, in the recurrent setting, as well as in the frontline setting for maintenance therapy.

Clear cell cancer is another area where there are a number of aberrations in the pathways so ARID1A mutations occur in about 50% of patients' tumors. PI 3-kinase, AKT, mTOR abnormalities occur in about a third of these tumors. There's a great opportunity to study targeted agents in that area. There have been some trials and there will be future trials as well.

The other thing I would mention for clear cell cancer is immune checkpoint-inhibitor treatments. There have been some very interesting responses in clear cell cancers with immune checkpoint drugs. And there will be future trials, that are currently in development, focused on the checkpoint inhibitors.

Do these rare types have symptoms or effects on the body that differ from the most common

No. Most of these rare ovarian cancers have symptoms that are not really differentiated from women who have the most common type, which is high-grade serous. Abdominal pain, bloating, those kinds of symptoms occur at the time of diagnosis.

Some of the patients with certain types live a very long time, because the diseases are indolent. That would be true for granulosa cell tumors as well as low-grade serous carcinomas. These patients may experience side-effects from treatment. It all is related to quality of life that they may have. Not only from the cancer, but from the many treatments. 

One of the areas where we're really reducing the amount of treatment is a success-story with malignant ovarian germ cell tumors. The average age at diagnosis is about 16 and up until the 1970s, most girls and women who have this type died of their disease. We had no good therapy. The introduction of Platinol (cisplatin) in the late 1970s completely transformed that area. Now the cure rate is 95%. However, these girls and women experience some of the side-effects of chemotherapy. Now, there's a big move, and a recent clinical trial, that focuses on reduction in the surgical treatment of germ cell tumors, as well as trying to completely get rid of chemotherapy in some patients, who have early-stage disease.

Sixteen is a very young age to encounter cancer. Can you discuss some of the specific concerns for those patients?

Late-effects and fertility are the two major concerns. Fortunately, for instance with germ-cell tumors and granulosa cell tumors, they are almost always unilateral, they only affect one ovary. In almost all of these patients, you can preserve a normal contralateral ovary and uterus, so you preserve their fertility. However, if the patients does receive chemotherapy, there's about a 15% rate, or frequency, of acute ovarian failure, making them infertile.

Most young patients are able to preserve their fertility. We’ve conducted studies to show that many of these young patients can go on to have normal pregnancies and normal offspring. That's good news. Once we start to reduce the amount of chemotherapy we're using in these patients, that will be even better, because then we won't have to face that 15% frequency of acute ovarian failure.

A big concern for many patients with ovarian cancer is the high-rate of recurrence. Does that

It is, unfortunately. All three of the rare epithelial types: clear cell, mucinous and low-grade serous are not very sensitive to the standard chemotherapy, which is typically Abraxane (paclitaxel) and Paraplatin (carboplatin). The recurrence rate in all three of those tumors are high, in the 70% range.

Fortunately, low-grade serous carcinoma, despite its insensitive to chemotherapy, is an indolent disease, as is granulosa cell. Patients can still live for many years. Clear cell and mucinous are fairly aggressive types. When they recur, they're very difficult to treat.

Is there anything else you’d like to say about these rare types of ovarian cancer?

We need a grass-roots advocacy movement to lobby not only Congress but the National Cancer Institute to put more emphasis on rare cancers, specifically rare ovarian cancers. That would be my plea. The only way we're going to advance treatments is to conduct clinical trials that prove that one treatment is better than the other. We really need the help of our advocates in that fight.

Ovarian cancer expert, David M. Gershenson, MD, from University of Texas MD Anderson Cancer Center discusses thre treatments for some of the rare types of ovarian cancers and the challenges to treating these diseases.

Rare Ovarian Cancers: Treatment and Challenges

Patients with cancer have an elevated risk of venous thromboembolism (VTE), and of recurrence of VTE. Karley Trautman, DNP, ANP-BC, of University of Colorado Hospital noticed that the numbers for VTE and recurrence of VTE in their Blood Cancer and Bone Marrow Transplant program seemed higher than even that rate. Along with her colleague, Chelsea Boggs, MS, AGANP-BC, Trautman set out to decrease the incidence rate and the recurrence rate of VTE, as well as control the rate of bleeding in their inpatients.

Using existing standards, the two nurse practitioners created a quality improvement program and were able to reduce their rates of VTE occurrence, VTE recurrence and their rate of bleeding.

Why did you decide to embark on this quality control project?

Blood clots are a big problem in the oncology population in general. Patients with cancer are at a significantly higher rate for both occurrence of blood clots and then recurrence. In our clinical practice, I work with patients with blood cancer and we see a high incidence of venous thromboembolism (VTE). I wanted to see what we could do to decrease the incidence rate and then also to decrease the recurrence rate, which was high.

The study showed that cancer patients are at about an 8%-20% risk of getting a clot in general, which is 4 times higher than what the normal population has, but the recurrence rate is about 20% higher in patients with cancer. What we found, at our institution, was that our recurrence rate is about 40%. I kind of knew just from clinical practice, that that was something that seemed higher than what it should be.

And we are at a unique position, where our patients are at risk for bleeding at well, from both their disease and their treatment. Because of that, we need to balance both the risk of clot and the risk of bleeding. That's what drove the project for us, determining that this is something we need to consider and look to the research to guide our practice.

What steps did you take to improve those rates?

We first did a literature search, to see what was out there. We found that the National Comprehensive Cancer Network (NCCN) has clinical practice guidelines for VTE prophylaxis and treatment. We also looked at what the literature says about preventing bleeding in this patient population, which is a pretty small amount of data and research. For the purposes of this quality improvement project, we used some of those bleeding prevention guidelines and married them with the NCCN guidelines about VTE. Then, we did a lot of education for our staff and providers, about how we were going to do the program. We had a systematic approach that we could then measure the outcomes.

Did you encounter any problems while implementing the program?

We had to do a lot of education and re-education. It seemed like things would take hold right away, and then started to slip. We had to go back and talk about things again. Sometimes I had to go to a physician colleague and say, "You didn't really follow our guidelines with this patient, what's going on?"

One of the things that we didn't predict was what to do with patients when they develop both bleeding and clotting at the same time. How do we work that into the guidelines? Honestly, what we've figured out is that you have to do it case-by-case, you can't just have a one-size fits all for it.

What are some of the outcomes and improvements that you’ve seen?

We started in August of 2014, so it's been about 2 ½ years. What we've seen is that our actual VTE rate has dropped. It started at about 13%, which is right in line with the baseline from what we know about the population. And it's dropped to 10%, which is a good start. Our recurrence rates have dropped significantly, from about 20% to closer to 10%.

The interesting thing is that we saw our bleeding rates drop, too. We just wanted them not to go up, but they decreased. We don't know exactly why that is, we're looking at it from a statistical standpoint. But just thinking it through, we think that possibly since we're not having to put as many people on anti-coagulation, because they're not developing clots, and therefore they're not bleeding

Additionally, before this project, we were only treating about 20% of our inpatients prophylactically for VTE. What the literature supports is that everyone, unless they meet the strict contra-indications, should be treated prophylactically. And with our project we saw that jump from 20% to about 50%.

We still have room to work and grow, to tweak some things so people feel more comfortable and safe, but we've seen some great outcomes that translate to some big cost savings. Not just for the patients, but also the healthcare system in general.

What are your next steps for this program?

We're going to continue to think about outpatient prophylaxis. Right now, the literature doesn't necessarily support that, but I suspect that's partly because it hasn't been looked at too much. We also need to continue to expand on dealing with thrombocytopenia and prophylaxis, because we’re still seeing clots with patients that are thrombocytopenic.

What would you say to other nurses who would like to make changes within their practice?

This was all driven by myself and another nurse practitioner. We were able to gather the literature and do all the work so when we presented it to our physician colleagues, it was easy for them to say “yes, let's start trying this.”

Sometimes it can feel, as a nurse or an advanced practice nurse, that we don't have as much control over changing true clinical guidelines but that's not true. We can drive this, because we're seeing the patients and we're seeing exactly where the problems lie. We took this quality improvement project and we're actually able to make research projects come out of it that can really contribute to this place in medicine that's a little lacking good research.

Karley Trautman, DNP, ANP-BC, explains her efforts to improve the rates of venous thromboembolism (VTE), as well as the rates of recurrence of VTE in the Blood Cancer and Bone Marrow Transplant program of University of Colorado Hospital.

Nurses as a Driving Force to Change Clinical Practice

After getting through her treatment for breast cancer, Ms. K* looked at the experience as an opportunity to get back into shape. She knew that she would have trouble motivating herself and needed a kick-start. It was an advertisement in her state newspaper that gave her just what she needed.

The ad was for Moving Forward Together 3, a study aiming to evaluate how to get breast cancer survivors to start and maintain an exercise routine.

There’s no question that exercise is good for patients and survivors of cancer. It’s an easy answer to the question of what survivors can do for themselves, once they’ve been declared “cancer-free.” However, getting started on exercising, and keeping up with it, can be difficult, and this is especially true for cancer survivors who have gone through physically taxing and exhausting treatment regimens.

Bernardine Pinto, PhD, associate dean for research and professor at the College of Nursing at the University of South Carolina, is the lead researcher on this study. “We know that exercise, becoming physically active, helps to improve patients’ recovery, in the sense that it improves their physical functioning, their mood, quality of life, and in some cases even fatigue,” Pinto said in an interview with

. “And then we have the issue of cancer patients being at increased risk for cardiovascular disease, diabetes, obesity and so on.”

The Moving Forward Together study will be open to women who are 21 years of age or older, have been diagnosed with stage 0-3 breast cancer in the past five years, are not participating in regular physical activity, can read and speak English, and have access to a telephone. Survivors must be able to walk without assistance and must live within the Eastern timezone.

Each of these survivors will receive a pedometer and then be paired with a fellow breast cancer survivor who has been trained through the American Cancer Society’s Reach to Recovery (RTR) program. “RTR is a peer-based program,” Pinto explained. “These are breast cancer survivors who have survived their treatment, and the ACS trained these individuals to help them to provide emotional and other kinds of support to patients at different times in diagnosis. They already know how to work with patients.”

Via weekly phone calls over 12 weeks, the RTR volunteers offer their survivor partners a home-based exercise program (mostly brisk walking) to help them gradually progress to exercise at least 150 minutes/week (this goal is consistent with the American College of Sports Medicine’s recommendation for cancer survivors). 

Investigators plan to enroll 150 women in the study that launched in April 2015 and will be completed in March 2020.

, Ms. K said that having a survivor for an exercise coach “was a big help,” because it allowed her to “not only talk to the professionals, but to talk to someone who had been through it as well, someone who truly understands what the obstacles may be, but was still telling me, ‘I know you're going to do well.’”

For Ms. L, a coach with Moving Forward Together 3, physical fitness was always a part of her recovery. “Establishing a regular walking routine was a part of getting back to something like normal,” she said. “And that was on three levels — not just physical, but also part of the mental and spiritual recovery.”

All three of those components are important to Ms. L, and to her counseling. She explained that patients in this program “have to be prepared to understand that there are going to be setbacks.” She went on, “I counsel thoughtful goal-setting and a lot of forgiveness and patience with yourself.”

Ms. K also stressed the importance of starting slowly. “The key is just to do it incrementally,” she said, “a little bit at a time.” She went on to explain that her coach was sympathetic. “If I was only able to get in two sessions in a week, she would ask how I felt and tell me, ‘I had times when it was tough, but I did as much as I possibly could.’ It helped, since I knew she had gone through it herself.”

Before Moving Forward Together 3 in South Carolina, Pinto led two similar studies in 2015. These studies also evaluated the effects of survivors receiving exercise-related telephone mentorship from fellow survivors. Early results show that the intervention was successful in getting cancer survivors to engage in exercise routines. Pinto said, “We found that [the participants’] physical activity had improved significantly from their baseline. Their vigor had improved. Their quality of life had improved. Their fatigue had gone down.”

After the initial 12-week program in the study enrolling now, there will also be a follow-up at the 6 month, 9 month and 12 month marks to determine whether survivors were able to maintain their exercise routines.

The focus of Moving Forward Together 3 is on helping survivors adopt and 

exercise. After the initial 12-week program has been completed, the study will examine three types of communication as maintenance strategies, including monthly phone calls, exercise logs and text messages/emails, to determine which is the most effective.

“The research shows how exercise can help cancer survivors with fitness, physical functioning and quality of life,” Pinto said. “In this partnership with the American Cancer Society, we hope to show how community-based organizations will be able to implement our home-based exercise program and help survivors become and stay physically active.”

If the study’s goals are met, researchers plan to conduct a larger trial of the program that will allow cancer care organizations that have been peer-based programs an opportunity to expand the scope of the services they offer to survivors of breast cancer.

Those interested in learning more about, or participating in, Moving Forward Together 3 may contact Kimberly Bowyer, University of South Carolina research assistant, at 803-777-3909, 888-829-1916 or 

. Participants do not have to live in South Carolina, but they must live in the Eastern time zone to participate.

Moving Forward Together 3 is a study evaluating how to get breast cancer survivors exercising, by using other breast cancer survivors as coaches.

Moving Forward Together 3: Breast Cancer Survivors Exercising Together

Participation in clinical trials in the United States is much lower than many clinicians would hope. However, this issue is more complicated than patients simply choosing not to participate. Often, there can be barriers to clinical trials that are felt more acutely by patients in minority and other groups like the elderly where comorbidities can be a disincentive to their inclusion.

Clinical trials that lack diversity can lead to ethical, as well as efficacy, issues, however. In an interview with 

, Jennifer A. Wenzel, PhD, RN, CCM, FAAN, associate professor at Johns Hopkins University Schools of Nursing and of Medicine, explains what some of these barriers can look like, why diversity in trials is important, and how nurses can help encourage patients in minority populations to enroll in clinical trials.

: What are some barriers to clinical trials that minority patients can experience?

: There are certainly some barriers that affect a lot of people, issues like transportation or concern about income and perhaps the issue of being uninsured or underinsured. These are issues that cut across groups and, as with many things when we look at health disparities, they may impact minority populations more than other groups.

The issue of being mistrustful or warier of research can impact minority groups, specifically when we think about projects like Tuskegee where there have been egregious instances of research misconduct. We can see how that would impact certain groups more than others.

Another issue is how trials are communicated. We know that this is important, and we know that we're still struggling with challenges like cultural competence and communication bias, whether it’s overt or perhaps more implicit. How are clinical trials represented and are they represented at all to groups? One barrier might be that minority patients may hear less about clinical trials than other groups. Some of this comes from what we think of as a positive motivation—providers see a patient, and they make assumptions about protecting the patient and not creating what they might see as additional vulnerabilities for the patient, or complications related to their care. However, there are benefits to participating in trials.

Why is it important that clinical trials be diverse?

First, it's an issue of an essential ethical principle of justice. When we think about trials, some of our largest trials are funded through federal monies. We expect that these trials will be to benefit not just science but people. We want to make sure that those benefits are distributed equally.

To be able to generalize, from a scientific standpoint, these results to all groups, we must have representation from all groups. To be able to answer important questions about whether treatments, devices, or drugs impact some groups differently than others, we must have adequate sample size and representation so that we can make some subgroup analyses. We really have learned from some important missteps that not all groups respond to the same treatment, to the same drugs, to the same devices, in the same way.

How can nurses encourage patients from minority populations to enroll in the clinical trial?

Nurses may sometimes perceive more burden for patients. Better understanding of clinical trials, and the importance for patients of engaging in clinical trials, would help. Clinical trials do create some complexity on the front-end of treatment, there's no doubt about that, and even during treatment it may require some additional visits.

Particularly for minority patients, there may be concerns about the community at large and some of the disadvantages that they observe in the community. Many times there is an extra burden for them [minority patients], in terms of wanting to make sure that their experience does benefit other people from a community that they see as having been left behind.

In speaking with patients on this topic, there was a clear understanding that minorities have been left out many times in the past. We must make sure that we're focusing on inclusivity and making it possible for them to be not just invited, but to be successful in terms of being enrolled to clinical trials. That's an important step forward when we think about research ethics, when we think about equity, in terms of healthcare access.

Nurses have a lot of respect from patients. Nurses are perceived as having less at stake in terms of research trials, and nurse navigators may be perceived as someone who is particularly focused on the patient, and perhaps on the family. The family is another really important opportunity, and it's probably the area that we've researched the least when it comes to clinical trial recruitment and retention—how families are part of healthcare decisions and how they're critical to success.

You led a nurse/community health worker navigation intervention involving caregivers. Why is it important to educate the caregiver?

It is probably the next step for us, in our work at Hopkins, is to look at what we call decision partners. Decision partners might not be caregivers in the strictest sense. They were, though, sometimes the main drivers of the clinical trial decision. Patients, and particularly our minority patients, or seniors, have a lot of concerns about family burden. They may defer the decision about whether to participate in a clinical trial to their family, or to their decision partner.

In other words, if the decision partner, who is in many cases the least likely to be on board when it comes to clinical trial participation, is not excited about the opportunity, then the patient may perceive that the family has enough burden with the disease and the treatment and that participating in the trial will add too much burden, so the patient may decide not to participate in the trial.

In these circumstances, the patients were probably the most likely to regret that decision. On their own, they probably would have made the decision to participate. It's observed as a missed opportunity to leave behind an important legacy.

I mentioned that the decision partners are probably the most likely to be against the idea of participating in research. I think a lot of that is because we don't include them in the conversation. Everything they're hearing is secondhand. When you hear things secondhand, you don't have the opportunity to ask questions, and you don't have the opportunity to share what your reservations are and to see if those can be overcome.

What tips can you offer to nurses in smaller clinics and practices?

Nurses who work in smaller centers are extremely resourceful at helping patients. A lot of times in smaller centers, we don't always have the people to refer to. We become really savvy about what some of the internal and even some of the community-level resources are. There are opportunities; for example, if transportation is an issue, “here's how we might be able to address this. Here are some community level resources, for people of your age, or in your geographic location. Here are some center resources.”

When people have a diagnosis of cancer, sometimes patients and families are inundated with offers of help, but it's hard for them to identify where people can help them. Nurses and navigators can be helpful in tapping into some of those resources. There is a tendency toward independence, self-reliance, the important of autonomy, and self-regulation—managing things on your own&mdash;that can be a little counter-productive sometimes, during treatment.

That may also be a problem when we think about adding the complexities of participating in a clinical trial: We need to help patients and families, help decision partners realize that they’ll need support, at least as much as the patient does during this process. And they're probably the least likely to get assistance in our current healthcare system. Nurses can talk to them about how, in supporting the patient during treatment and trial participation, they’ll need some support as well. “What are your resources? How can we be helpful to you in this process?” Because the truth is, we depend on caregivers quite a lot. We are delegating a lot more responsibility… but we're not necessarily allocating more resources or support to them.

What policies might help to improve clinical trial recruitment?

When we think about advocating policies that are supportive, the truth is, research funding promotes good science, but with very strict budgets. And as we tighten those budgets, sometimes what really falls by the wayside are specific programs and interventions to make sure that our research populations are diverse. From a nursing perspective, from a research perspective, we can advocate for funding that really allows for a research plan and a research approach that will promote adequate representation in trials. It shouldn’t be an afterthought, but rather, a specific plan to ensure adequate enrollment and retention.

Barriers to clinical trials can more acutely affect patients in minority and other groups -- such as the elderly.

Research Equity: Overcoming Barriers to Clinical Trials

Kathleen Emmets was 35 when she was diagnosed with stage IV colon cancer, and she immediately found an outlet in writing.

From the time she was told her disease was inoperable and that her days were numbered, through better moments after she learned that treatment was available, Emmets wrote everything from social media posts to longer essays. Among that work is a recent piece looking back on her initial devastating prognosis, titled “

” which describes the beautiful moments Emmets has experienced due to decisions she made while believing she had 18 months to live.

The piece came to her in a moment of pure inspiration. “The way I wrote that piece was exactly as it played out,” she recalled. “Just sitting and looking over at my boyfriend. Going outside and taking a breath. Thinking of the enormity of what had gone on in the past six years. And I just started writing.”

On April 3, Emmets’ piece was featured in the 9th annual night of live readings hosted by the Visible Ink writing program based at Memorial Sloan Kettering Cancer Center (MSK), in New York. After she became a patient there, Emmets joined the program that helps patients to write about their journeys, and her work within the group helped her hone and finish the essay.

Every fall, Visible Ink has a call for submissions, and from hundreds, a selection committee chooses no more than 15 to be performed “by amazing people, mostly from Broadway, who come in and do this pro bono,” explains writer Judith Kelman, who leads Visible Ink. The performers are actors, singers and dancers, including Tony Award winners.

Greg Kachejian, an actor who used to run the now-defunct patient library at MSK, first suggested bringing the pieces to life by putting together a performance. “He has a lot of friends in the Broadway community,” Kelman says, and puts the presentations together “in a rhythm that works for the evening … We have some pieces by men, some by women, some that are funny, some that are really rough and difficult.”

Emmets’ essay, read by actress Catherine Augier, closed this year’s performance. “I was deeply honored that they thought enough about the piece to do that,” she says.

Emmets started writing on social media, specifically Facebook, using it as a platform to update everyone in her life at once. Her first post, the day after she was diagnosed, just read: “cancer schmancer.”

“It was just a more in-depth way of explaining what was going on,” Emmets says. Social media not only allowed her to express herself, but gave her a support system and a community.

It was in treatment at MSK that she discovered Visible Ink. Founded in 2008 by Kelman, Visible ink pairs patients with writing mentors and allows them to write about anything they’d like. Since its start, the program has expanded from eight patients and one mentor to over 1,600 patients and more than 200 mentors. The program is free of charge and open to any patients, regardless of age, background, severity of illness, writing ability, educational level or perspective.

All the patients contact Kelman first for a conversation. “I hear about what they’re being treated for and what their wish is in terms of expressive writing,” she says. It was always important to Kelman that participants be allowed to “express themselves on any topic, in any form.”

Kelman referred to the vast amount of evidence supporting expressive writing as an intervention, commenting that the writing allows patients to “get back in charge of their personal narrative, as they define it.” With cancer treatment, patients are often told and prescribed a lot of things to do. “It’s necessary to abdicate a part of your personal self in order to go along with that,” Kelman explains. “If I said, ‘Come in every Tuesday at 12:30 and write about your illness,’ I’m just another treatment. I’m just another stricture.”

Normally, after speaking with Kelman, each patient is partnered with a mentor. When Emmets came along, Kelman decided she wanted to serve as mentor herself. Since then, Emmets has written for magazines and websites but, she says, doesn’t submit anything “without sending it to Judith first. She is my editor and my friend.”

Of the program, Emmets claims, “I honestly feel like I owe everything to it, because Judith made me a better writer.” She goes on to praise the program, saying, “It helped me give voice to my story. It helped me make sense of what has happened.”

During treatment, Emmets says the writing was cathartic for her. “There’s a safety in treatment, because you feel proactive,” she explains. “I find it most difficult to write about it now, emotionally.” Emmets related the feeling of being done with treatment for cancer to that of being a soldier finished with service. “You put in your time and they just say ‘goodbye,’ without giving you the tools to deal with everything.”

Emmets enthusiastically recommends Visible Ink to everyone being treated for cancer at MSK. Patients elsewhere can write on their own or look for writing groups at their hospitals or in their communities; hospital social workers may be able to recommend groups.

“It will help you sort out the thoughts in your head,” Emmets says. “You’re going to have really phenomenal days, and you’re going to have awful days. And if you journal, and if you keep track, during hard days you can look back and you can remember the great days, and they can pull you through. And you can read (about the horrible days) and you can pride yourself that you pulled through that.”

She continues, “Everyone has a story. And every story has value. For someone to take time out of their life to help you find your voice and help you tell your story, it’s an incredible gift that they’re giving to survivors, to patients.”

To see her own writing brought to life by a Broadway actor during the MSK event was a surreal experience for Emmets. At such a performance, she says, “you are immersed in the emotion of it. And to have people come up to me after the performance and say that they connected with my piece, to know that I had an impact on someone, that they saw their own story in mine, is amazing.” To Emmets, that’s what Visible Ink is all about, “that connection with other people.”

It wasn’t just watching her own piece being performed that was moving, though. Emmets explains that the entire show is a reminder of “this common human experience. While we think that we’re on this island of our own emotions and our own journey, that’s not the case. You hear the numbers of people who have cancer, and you can’t really connect with ‘millions.’ But (you) see it on stage and feel the emotion coursing through all these stories.” She says the sentiment might seem “trite,” but that connection is a reminder that “You’re really not alone.”

Kelman offered her own view of the performance, saying that the program recognizes patients for “who they are, not what they’re sick with. That really is important to people. They are not seen as a kidney cancer patient, or a brain cancer patient. Just a person, with a story.”

The Visible Ink program at Memorial Sloan Kettering Cancer Center helps patients and survivors express their stories and feelings through writing.

Visible Ink: Program Helps Patients Express Emotions Through Writing

The number of suicides in patients with cancer is nearly twice that of the general population. However, when compared with breast, prostate, and colorectal cancers (the 3 other most prevalent nonskin cancers), lung cancer—associated suicide rates are much higher, according to research presented at the recent 2017 ATS (American Thoracic Society) conference.

“We wanted to see what the impact of one of life’s most stressful events is on patients,” explained first author on the study, Mohamed Rahouma, MD, a postdoctoral cardiothoracic research fellow at Weill Cornell Medical College/New York Presbyterian Hospital. “I think it’s fair to say that most clinicians don’t think about suicide risk in cancer patients. This study, I hope, will change that by making us more aware of those at greatest risk of suicide so that this catastrophe in the care of our patients doesn’t happen.”

, Jeffrey L. Port, MD, senior author on the study, specializing in cardiothoracic surgery with Weill Cornell Medicine, added, “I think we as doctors do a good job with the physical examination and understanding the laboratories and imaging, but we don't necessarily do a thorough emotional or psychosocial evaluation.”

Using the Surveillance, Epidemiology, and End Results (SEER) database, researchers studied the suicide deaths in all cancers, as well as in specific types (lung, prostate, breast, and colorectal) over a period of 40 years (1973-2017). For each type, researchers also looked at the suicide trends over time and the time from cancer diagnosis to suicide for each type. To focus on lung cancer, the researchers also recorded demographic, social, and tumor-related factors, hoping to get a better idea of who would be at a high-risk.

Suicide Risk Among Patients With Cancer by the Numbers

Of the 3,640,229 patients with cancer studied, researchers found 6661 cancer-associated deaths by suicide, which were most notable among patients with lung cancer. Compared with the general population, patients with cancer had a 60% higher suicide rate. Patients with lung cancer had a 420% higher rate, colorectal cancer was 40% higher, and breast and prostate cancers were both 20% higher.

“There’s no doubt that lung cancer is a serious diagnosis,” Port said. “A patient gets a diagnosis, and then a treatment plan that’s pretty extensive, and it can include chemotherapy, radiation, and even surgery. There’s a lot to handle there. It’s often overwhelming, early on.”

This stress can be compounded when there are other medical conditions to consider. “Many of our patients have extensive comorbidities, the same group of patients that have heart disease from smoking, and many of them are older and more frail,” Port said.

Patients with lung cancer can also feel a lack of support due to the stigma associated with this disease. “This is considered a disease they brought upon themselves by smoking,” Port said. “There's not as much emotional support or sympathy perhaps, they feel, as other types of cancers.”

, published by the CDC’s National Center for Health Statistics show that the general population has a suicide rate of 13/100,000 person-years. Researchers found that the cancer-associated suicide rate is more than double that, at 27.5/100,000 person-years, standardized mortality rate 1.6.

The standardized mortality rate, or SMR, compares the number of deaths in the study population to the number of deaths expected in the standard population. Patients with lung cancer had the highest SMR at 4.2―this population is also the only one to exceed the SMR for all cancer patients. Colorectal cancer and breast cancer both had a SMR of 1.4, while prostate cancer had an SMR of 1.2.

Lung cancer patients also showed the least amount of time between diagnosis and suicide―a median of 7 months. All other types proved far higher―for colorectal cancer the median was 37 months, breast cancer was 52 months, and prostate cancer was 56 months.

“What’s striking to me, regardless of the stage of the diagnosis, having lung cancer is portrayed with a terminal outcome,” Port commented. “If a patient starts asking about numbers and chances of cure, compared to breast and prostate for example, the results are not as favorable.”

However, there has been an overall trend toward a decrease in suicide over time, and this decrease has been more noticeable in patients with lung cancer. Port hopes this trend will continue, “as we talk about things like CAT scan screening, liquid biopsy, and potentially blood tests in the future,” to provide for better screening and earlier diagnosis. “There’s reason to be hopeful.”

Supporting Patients With Lung Cancer: What Clinicians Can Do

Importantly, the researchers determined the factors that could indicate a patient with lung cancer would be at high risk for suicide. They found that patients with lung cancer were more likely to die by suicide if they were male, Asian, widowed, older (70-75 years), refused surgical treatment or had a difficult-to-treat type of cancer (metastatic, small-cell lung carcinoma histology).

Identifying these high-risk patients is important as it can allow clinicians to provide psychological assessment, support, and counseling to reduce the rates of suicide. Port added, “We have to do a better job in assessing those emotional needs as well. If we can do that, and we can tease out the risk factors, then you can intervene earlier.” Port explained that intervention could as simpler as a referral to a social worker, psychologist, or psychiatrist.

“While cancer diagnosis counseling is an established practice, especially if a patient seems depressed, referral for ongoing psychological support and counseling typically does not happen,” Rahouma said. “This represents a lost opportunity to help patients with a devastating diagnosis.”

Port also commented on what an elevated rate of suicide, as seen in the population of cancer patients, implies. “It’s not just about suicide,” he noted. “If you have these higher suicide rates, it must also imply that there’s a higher distress level among all of our patients. That’s what’s important here.”

Researchers found that the rate of suicide in patients with lung cancer is much higher than those with other types of cancer.

Suicide Risk and Lung Cancer: Are Clinicians Aware?

Senate Republican leaders released their draft of a bill to repeal and replace the Affordable Care Act (Obamacare) June 22, and immediately stakeholders began to weigh in on its implications, including practitioner groups and patient advocates.

Providing a rationale for the legislation, Senate Majority Leader Mitch McConnell (R-Kentucky) said on the Senate floor, “Republicans believe we have a responsibility to act and we are. For our constituents, for our states, and for our country.”

The Senate plan in many aspects is like the American Health Care Act passed by the US House of Representatives May 4 in a 217-213 vote. However, the Senate bill, called the Better Care Reconciliation Act of 2017 (BCRA), would factor in age, income and geography when determining financial assistance to help individuals pay their premiums, whereas the House version did not include income in this calculation.

Both the House and Senate versions propose deep cuts to Medicaid and would phase out Obamacare’s expansion of the program, although the Senate version would phase the expansion out on a slower timetable; both bills would also convert Medicaid to a block grant program.

Other ways the Senate bill differs from Obamacare include repeal of the mandates that individuals carry health insurance and that employers with 50 or more employees provide it. Additionally, where the ACA allowed insurers to charge a maximum of 3 times their lowest rate to older consumers, this bill changes that age rating to 5-1―meaning insurers would be able to charge older adults up to 5 times what they are charging younger adults.

Holdover protections the Senate retained from Obamacare are the provisions allowing individuals to remain on their parents’ health insurance through age 26 and preventing exclusion based on preexisting conditions. The Senate bill does not include stipulations which allow states to charge individuals more based on preexisting conditions, which the House bill included. However, it does grant states more flexibility in deciding the rules of insurance in their state.

Also, funding for cost-sharing reduction payments, which decrease the out-of-pocket costs for some low-income individuals, will continue through 2019.

In a statement June 20, McConnell stated that Obamacare trends are unsustainable and his chamber’s legislation to repeal and replace the law is necessary due to the instability of the insurance market, leading to higher costs and less choices for many consumers.

Senate Minority Leader Charles E. Schumer (D-New York), however, countered that these proposed changes, “will result in higher costs, less care, and millions of Americans will lose their health insurance, particularly through Medicaid.”

The American Nurses Association (ANA) expressed its opposition to the bill at a press event with Senators Debbie Stabenow (D-Michigan), Maggie Hassan (D-New Hampshire) and Jeff Merkley (D-Oregon) along with nurses from Michigan, Ohio, Pennsylvania, West Virginia, Maryland, and Virginia, including ANA President Pam Cipriano, PhD, RN, NEA-BC, FAAN.

At that event, Cipriano stated, “The Senate’s healthcare proposal would be disastrous for our nation’s most vulnerable. We will not be fooled. This is not a promise kept. This is a promise broken. This proposal is heartless. We are nurses and we are worried about our patients. We will not stop fighting for them. We can—and must&mdash;do better.”

The American Society of Clinical Oncology (ASCO) also issued a statement June 22 in opposition to the bill: “We are disappointed that the legislation fails to meet our guiding principles for healthcare reform by halting Medicare expansion, reinstating annual and lifetime coverage caps, and cutting coverage for essential health benefits including cancer screening. These provisions are critical to providing high-quality cancer care in this country and lead to even greater state-by-state disparities in the delivery of care.”

As the Senate revealed their healthcare reconciliation bill, healthcare advocacy and profession organizations weighed in.

Allie Casey