African American patients with cancer are more likely to enroll in a clinical trial if their primary oncologist is one of the trial investigators, according to a presentation from the 

 Moreover, findings showed that African American patients with lung cancer are just as, if not more, knowledgeable about clinical trial enrollment as White patients with lung cancer, and highlighted that 1 key barrier to enrollment between the 2 groups may be an issue of trust.

“The way [respondents] expressed themselves was telling in terms of the trust for the physician,” Faith Mutale, CRNP, of the Abramson Cancer Center at the University of Pennsylvania, who presented the findings during the meeting, said in an interview with 

. “Some of the participants would say, ‘I don’t trust the medical system, but I trust my physician because they’ve shown interest in my individual well-being.’ ”

Understanding the role that trust plays in clinical trial enrollment is crucial for efforts to diversify research, Mutale added, particularly among the African American community, where there has been a history of abuse and misinformation.

Less than 5% of patients in the general population with cancer enroll in clinical trials.

 Among African American patients with cancer, enrollment rates are even fewer, even though African Americans comprise about 13% of the United States population.

 For other minorities, enrollment numbers are even lower.

The reason for lower enrollment rates is multifaceted, Mutale said. However, obtaining a better understanding of what motivates these patients to enroll was part of the impetus behind a clinical project that Mutale helped launch at her institution.

The study looked at 2 different sites within the Matrix Cancer Centers, comprising different ethnic populations. One center has a mixed racial population and the other primarily treats African American patients. The cohort size was 65 patients, and the primary end point was to explore clinical trial knowledge and factors that influence attitudes and willingness to enroll onto a clinical trial among African American patients with lung cancer using a survey.

“We were going into this project with several assumptions, one of which was [that] participants from the primary site were more likely to have clinical trial knowledge and interest to enroll, as opposed to the affiliate site,” Mutale said. “But that wasn’t [the case].”

How can oncology nurses address this lack of trust?

According to Mutale, nurses will be at the forefront of bridging this barrier to care. Specifically, nurse navigators may play a role in helping keep patients both informed, and well-advocated, as they navigate the process of clinical trial enrollment.

“Nurse navigators have the ability to inform or educate patients about what’s available,” Mutale explained. “Patients may not be very comfortable discussing these things upfront, particularly after the first visit. However, they may then go the navigator and talk about what [clinical trials] are and what this may mean for them.”

Alongside nurse navigators, social workers have the potential to make patients feel both at ease, and well supported throughout their cancer journey, Mutale added. “Some of our patients just felt very comfortable talking to someone who looked like them,” she said, emphasizing that it’s not just the information that matters, but feeling as though your provider understands you and is invested in your well-being that is critical as well.

“In my experience, having a navigator and a social worker has always been very helpful. Their presence can [have] a calming effect in a nonthreatening way,” she said.

Overall, a paradigm shift is necessary in oncology, according to Mutale. At an institutional level, there is a need is a need to develop nurse-driven programs to combat disparities in clinical trial enrollment. There also needs to be a push for specific training for the role of the “clinical trial educator,” as Mutale calls them. “I coined this particularly nurses who are members of minority groups. Patients must feel and know that the providers interest goes beyond the trial but for each individual patient outcomes as well.”

Based on these findings from the phase 1 part of the study, investigators are now launching a phase 2 study.

Mutale FA. Sandy B. Inclusion of minorities in cancer clinical trials: where are we now? Presented at: 6th Annual School of Nursing Oncology®; July 29-30, 2022; San Diego, CA.

Unger JM, Cook E, Tai E, Bleyer A. The role of clinical trial participation in cancer research: barriers, evidence, and strategies. Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.1200/EDBK_156686

Siegal RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. doi:10.3322/caac.21654

Articles

Faith Mutale, CRNP, discusses the paradigm shift needed in oncology to address clinical trial enrollment hesitancy among African American patients with lung cancer.

Nurse Navigators Can Help Alleviate Medical Distrust, Improve Clinical Trial Enrollment

Nurse navigators may play a key role in mitigating toxicities from chemotherapy and perform geriatric assessments for patients treated at hematology/oncology clinics, according to data from a pilot project presented at the 2022 ASCO Annual Meeting.

Investigators assessed the use of the G8 questionnaire to identify vulnerable geriatric patients with cancer and the Cancer and Aging Research Group (CARG) scoring tool to calculate chemotherapy toxicity risk among patients aged 65 years or older. These tools are used to stratify those at-risk for severe adverse effects using information beyond age as a guide for treatment decisions and improve outcomes. The tools also aid in the referral of patients with vulnerabilities to external services for follow-up treatment.

Completion rate of these assessments is between 20% and 35% when administered by physicians and investigators sought to improve completion rates with assistance of nurse navigators.

Seven community cancer centers were included in the pilot program and the study period lasted from May 1, 2021, to December 31, 2021, G8 assessment was administered at all 7 sites and CARG plus G8 assessments were administered among patients with solid tumors receiving chemotherapy at 4 of the 7 sites.

In total, 1372 patients were eligible to undergo G8 assessment and 563 were eligible for CARG assessment. The completion rates of the assessments were 78.9% and 91.6%, respectively, when administered by a nurse navigator.

“Nurse navigators can successfully implement G8 and CARG toxicity tool in hematology-oncology clinics in a broad range of cancer types at a high rate with resultant referrals to multiple supportive services in real-world settings,” the study authors wrote in a poster of the data.

Referrals to external services were also initiated among the population and included 193 referrals for nutrition services, 30 for audiology, 18 for physical therapy, 5 for psychiatry, and 5 for neurology. The median age of patients in the eligible population was 74 years (range, 65-100) with a near even split between men (48%) and women (52%). Patients has a range of cancers including genitourinary (18%), breast (17%), upper gastrointestinal (15%), and thoracic cancers (13%).

The G8 assessment produces a score ranging from 0 to 17 based on fitness characteristics of patients.

Has food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties?

Mobility (ie, able to get out of bed/chair)

Neuropsychological problems (ie, severe dementia or depression)

Heath assessed in comparison with other individuals the patient’s age

The CARG tool is used to predict cardiac toxicity based on a range of factors including the following

Primary tumor site (ie, genitourinary or gastrointestinal cancer)

Laboratory results (ie, hemoglobin and creatinine clearance)

Socialization (ie, observed decreases because of physical and emotional health)

ASCO guidelines for geriatric oncology recommend that patients aged 65 years and older should undergo assessment to identify risks that not routinely captured in clinical assessments. The recommendations include both the G8 and CARG tools as supplemental assessments for geriatric assessment in the clinic.

Shaia JL, Liu R, Sun H, et al. Nurse navigator–initiated geriatric assessments in hematology/oncology clinics. 

. 2022;40(suppl 16):12051. doi:10.1200/JCO.2022.40.16_suppl.12051

Bellera CA, Rainfray M, Mathoulin-Pélisser S, et al. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. 

. 2021;23(8): 2166-2172. doi:10.1093/annonc/mdr587

Kim J, Hurria A. Determining chemotherapy tolerance in older patients with cancer. 

. 2013;11(12):1494-502. doi:10.6004/jnccn.2013.0176

Mohile SG, Dale W, Somerfield MR, et al. Practical assessment and management of vulnerabilities in older patients receiving chemotherapy: ASCO guideline for geriatric oncology. 

Nurse navigators may play a key role in mitigating toxicities from chemotherapy and perform geriatric assessments for patients treated at hematology/oncology clinics.

Geriatric Assessment Rates Improve With Nurse Navigator Intervention

Black patients with metastatic breast cancer were less likely to have a discussion about clinical trials with their health care providers, were less likely to trust the trials in general, and had greater reservations about the safety of investigational agents, compared with their White counterparts, according to findings from a recently completed survey.

Specifically, the survey found that although 83% of Black patients with metastatic breast cancer would be interested in participating in clinical trials, only 40% reported their provider having a conversation with them about a trial.

The results of the survey, which were presented during a press briefing ahead of the 

, show that action needs to be taken to address these barriers and ensure more Black patients with metastatic breast cancer are included in clinical trials, according to Stephanie Walker, a patient living with metastatic breast cancer and an advocate with the Metastatic Breast Cancer Alliance, who led this survey.

Walker, who is Black, said that only when a trial population represents the diversity of the general population can oncologists truly evaluate how a treatment works across different populations.

The purpose of the survey, which is a part of the BECOME initiative, was to better understand the barriers Black patients with metastatic breast cancer face in regard to participating in clinical trials. It was administered via social media, as well as by members of the Metastatic Breast Cancer Alliance and included 424 patients with metastatic breast cancer, 102 who self-identified as Black.

Black respondents trust and satisfaction rates with their oncology team were high, above 90%, and 83% of Black respondents were somewhat or very likely to consider participation in a clinical trial. However, 40% reported that their care team had not discussed clinical trials with them.

Additionally, Black respondents were more likely than non-Black respondents to believe unstudied treatments may be harmful (57% vs 31%) and were less likely to trust trials (73% vs 91%).

Other reasons for not participating in a clinical trial included worry about side effects (73%) and effectiveness (63%), as well as logistics such as travel and added cost.

Black respondents were also less likely than non-Black respondents to trust that people of all race and ethnicities would be given fair treatment in a trial (32% vs 56%) and would be more motivated to participate if there were assurance people of their race would benefit (83%).

Furthermore, Black respondents were more likely than non-Black respondents to value information on clinical trials if given by someone who is same race or ethnicity (67% versus 10%), has had breast cancer (73% vs 44%) or metastatic breast cancer (73% vs 51%).

As noted in the results, Black patients with metastatic breast cancer are willing to participate in clinical trials; however, more must be done to increase their participation. Walker said taking action to better inform patients, inspire their trust, ensure access to clinical trial and address their concerns could increase this participation.

As noted in the results, Walker said that bringing in people who have been through a similar journey with race and breast cancer could help inspire this participation and trust.

“We want to inspire Black people with metastatic breast cancer to participate in these clinical trials,” Walker explained. “So, in order for that to happen, we trust people that look like us, that are from the same racial or ethnic background, those that have … participated in clinical trials, those that have had breast cancer or metastatic breast cancer.”

Walker added that clinical trials are often held at teaching/university-based cancer centers, and not community-based cancer centers where some of these patients may be receiving treatment; therefore, they don’t know about them nor do they have access to them, another barrier Black patients with metastatic breast cancer may face.

“To address the concerns that we have, you need to communicate clearly about the issues and worries that metastatic breast cancer patients have. You have to understand that some of the compelling motivation for Black patients to participate in clinical trials is to ensure that people like (them) will benefit,” Walker said.

Additionally, Walker said all stakeholders have a role to play in increasing participation. This includes expanding the survey-respondent base, meaning investigators hope to reach a broader group of people to better represent the Black patient experience. Members of the BECOME initiative will also meet with other groups to share results and create strategies to improve care, she said.

Other initiatives that could increase participation, Walker added, include improved patient education, training health care providers on effective patient communication and helping patients find and access clinical trials.

She highlighted that healthcare providers should be educated on how to communicate with Black patients because they go through a different experience, and they need to better understand those who are in rural communities might not have the access they would need to participate in a clinical trial.

“You need to know where we are coming from. You need to know what we go home to everyday isn’t always what you believe it be, as the white patient has all the support and resources that they need,” she concluded.

Walker S, Carlson M, White CB, Howell J, Felder TM. Increasing Black patient participation in metastatic breast cancer clinical trials: the BECOME (Black Experience of Clinical Trials and Opportunities for Meaningful Engagement) project. 

. 2022;40(suppl 16):1014. doi:10.1200/JCO.2022.40.16_suppl.1014

Although 83% of Black patients with metastatic breast cancer expressed interest in clinical trials, only 40% reported having a conversation about enrollment with their health care provider, highlighting one of many potential barriers to achieving clinical trial diversity.  

Black Patients With Metastatic Breast Cancer Experience More Hesitancy With Clinical Trial Enrollment

As biosimilars continue to be approved for cancer-specific agents, the role of the oncology nurse in implementing and educating patients about their use becomes more pronounced, according to Kellie Zeichner, RN, BSN, OCN.

“[The Biologics Price Competition and Innovation Act of 2009] generated a licensure pathway for biologic products which [have been] proven to be biosimilar to or interchangeable with FDA[-approved] biologic products,” Zeichner, an oncology nurse with the Rutgers Cancer Institute of New Jersey who has experience working with biosimilars, said in an interview with 

Frequently used agents in oncology care—trastuzumab (Herceptin), rituximab (Rituxan), and pegfilgrastim—all have approved interchangeable products. Most recently, bevacizumab (Avastin) added a third FDA-approval biosimilar, bevacizumab-maly (Alymsys) in April 2022.

In the discussion, Zeichner highlighted the vital components of the development of biosimilars and interchangeable products that oncology nurses need to know.

 Please contextualize how biosimilars compare with their reference products.

[Biosimilars] are large, complex molecules made from living sources that are not identical but very similar to approved reference or brand drugs [with slight alterations and inactive components]. There are no clinically meaningful variants in safety, purity, or strength.

Biosimilars differ from generic drugs in their complexity and the manner [in] which they are manufactured. The cell lines that are processed [for reference products] are proprietary for biologics; therefore, the original product can never be duplicated precisely, and an exact copy of a biologic cannot be made. This is different from a small molecule drug, which can be copied with insignificant or no variable change from the original. The process of biosimilar manufacturing is rigorous [and is conducted] in a highly controlled environment.

The products are tested on several levels, which include preclinical, structural, and operational levels for safety, efficacy, and immunogenicity. [The biosimilars] must meet FDA standards—they have to be manufactured in an FDA-licensed facility, and they must be tracked as part of post marketing surveillance to ensure continued safety, which is of the utmost importance.

What is the approval process for a biosimilar?

Following the approval of [an] original brand drug, there is a period of market protection. For [approximately] 10 years there is an order to safeguard the reimbursement of research and developmental costs—which are quite high—for [the reference] biological agents.

Once this period has expired, biosimilars are legally allowed to be created. At this point, submission can be placed for a licensed application of biosimilar or an interchangeable [biosimilar product]. Then, through analytical data, animal testing, and clinical studies, an applicant must prove that there is no clinically meaningful difference in safety, purity, and strength between the biosimilar and the reference drug. Biosimilars can be approved as interchangeable either at initial approval, or at supplemental approval, if switching studies are conducted.

Please expand on the differences of an interchangeable biosimilar.

What is an interchangeable? This is a biosimilar product that can be substituted for a brand product without the intervention of the health care provider who prescribed it.

 To demonstrate interchangeability, [the FDA] requires that the biosimilar will produce the same clinical result as a brand product for any given patient and that it presents no additional risk to the patient if a switch between a product had occurred.

All biosimilars have a nonproprietary name and a suffix that is attached to the [reference product name], [this] always has a hyphen at the end [followed by 4 lowercase letters, of which 3 are distinct. They don’t carry any meaning at all, [but are there to ensure] that the biosimilar cannot be capable of being mistaken for the name of a current drug that is marketed already.

The intent for this is 2-fold. [One purpose] is patient safety, [specifically] to prevent patients from receiving medication that was not the intended biologic product prescribed and to avoid switching [to] biologics that are not deemed interchangeable. [The hyphen also serves] for tracking. It allows manufacturers specific tracking and most importantly, the remediation of adverse events should one occur.

Why is immunogenicity important when discussing a biosimilar?

Immunogenicity is an immune response [triggered by] a host against the therapeutic protein or the drug. It is an important concern regarding the efficacy and safety of biologics.

Biologics are more structurally complex than chemical drugs, and even a small variation in their manufacturing can cause undetected changes in [the] biologic composition of the product. These minor differences between a biosimilar and a reference biologic product could lead to the development of an anti-drug antibody.

At least 1 comparative parallel arm clinical trial must be done to assess the potential difference in immune response between the reference product and the biosimilar. Most importantly, the biosimilar approval process should prove that the biosimilar does not present a greater risk than the [reference] or the brand drug does. This is done through a highly complex and fully validated approach for detecting anti-drug antibodies and a head-to-head comparison of immunogenicity testing between the biosimilar and the reference product.

Implementation of the biologics price competition and innovation act of 2009. FDA. Updated Feburary12, 2016. Accessed June 2, 2022. 

FDA approves Alymsys (bevacizumab-maly), a biosimilar of bevacizumab by Amneal Pharmaceuticals, Inc., developed by mAbxience. News release. Brand Institute, Inc. April 18, 2022. Accessed June 2, 2022. https://prn.to/3k7MGt7

Biosimilar and interchangeable biologics: more treatment choices. FDA. Updated October 12, 2021. Accessed June 2, 2022. 

Kellie Zeichner, RN, BSN, OCN, discusses the production of biosimilars, their approval and naming processes, and why immunogenicity is important when discussing these agents. 

The Basics of Biosimilars for Oncology Nurses

For patients with cancer who are at the end of their life, being afforded the same level of autonomy in death as they experienced is life can be a vital component in providing quality care for the patient and their family, according to Lisa Vigil Schattinger, MSN, RN.

Schattinger is the founder and Executive Director of Ohio End of Life Options, a nonprofit organization that advocates for and provides education on medical aid in dying laws. In addition to being a nurse advocate, she also brings a unique personal perspective to her career.

Schattinger’s stepfather electively chose medical assistance in end-of-life care under Oregon’s Death with Dignity Act

 after he received a myelodysplastic syndrome diagnosis and learned he was not eligible for blood marrow transplant. He opted not to start chemotherapy but enrolled in hospice and received palliative packed red blood cell transfusions before electing to pursue a medically assisted death.

Her stepfather’s death was incredibly peaceful and in accordance with his wishes: he was able to walk himself into his room, sit down on the bed, and be surrounded by family as he took the medication.

“He felt empowered,” she recalled, noting that the family was grateful that the state of Oregon had allowed them this option.

At that moment, Schattinger and her mother, who is also a nurse, recognized that this option is potentially groundbreaking for certain patients and their families. As a result, they decided to learn more about the processes in place and to share their own personal experiences. Recently, the duo presented on the topic at the 

47th Annual Oncology Nursing Society Congress

 , specifically on the role of oncology nurses in end-of-life care and the key components of medical aid in dying (MAiD) or dying with dignity laws.

®, Schattinger provides a quick overview of her presentation and key takeaways for nurses seeking to provide quality care.

: Please provide a brief overview of medical aid in dying.

 Medical aid in dying is a law that allows terminally ill and mentally capable adults the ability to request a prescription that will hasten their imminent death. The process is patient directed; it is a voluntary process that has multiple safeguards. It is for an [individual] who understands that they are at the end of their life, understands that they are dying, and wants to determine the time and the place and [the company present] at the end of their lives.

Each state can determine if they are going to pursue the process of passing an aid [with the establishment of a] dying law or medical aid in dying law. The first one that [was passed] was in Oregon, and it is called the Death with Dignity Act. I always consider that one as kind of a baseline. As other states passed [similar] laws, they put their “thumbprint” on that law— they made it work for their state.

Currently it is legal in Oregon, Washington, California, Hawaii, Colorado, New Mexico, Vermont, Washington, DC, New Jersey, and Maine. [In addition], there was a Montana State Supreme Court decision that allows [MAiD], but it is not exactly the same as in places that have actual laws.

[To qualify], patients have to be capable of making decisions. If there is any concern that the person is not capable of making decisions, then they can be referred for a mental health evaluation. Then there are timeframes in place [these vary by state, as well]. A patient also needs a written request that is witnessed by 2 people, of whom at least 1 cannot be related to or benefit in any way from the person’s death. Then, after qualifying for the prescription, they must wait 48 hours before filling. Patients must also be able to self-administer the medication.

Anybody involved in this process can opt out at any time, physicians, pharmacists, nurses, [or] any other care provider can opt not to participate [in the process]. Of course, the patient themselves can change their mind at any time and stop the process as well.

It is also important to note that when a physician gets this request, they must inform the person of all [available end-of-life options], including hospice care.

[Interestingly] we have learned that [approximately] a third of the [individuals] who get this prescription never end up taking it. There are a combination of things going on there. [Some] say that they can relax knowing that they are able to determine if [and when] their suffering becomes too great. Others, [unfortunately,] do decline in health. And [those] who are not able to self-administer, are no longer capable of making that decision

Should oncology nurses only be familiar with these laws if they live in a state where it is legal? How might nurses support a patient who wants MAiD, yet lives in a state where it is not an option?

The American Nurses Association put out a statement saying that because so many people now have access to this option at the end-of-life that they feel nurses are ethically bound to be knowledgeable about it. This means being able to have non-judgmental conversations about MAiD, and to be able to [inform individuals] about what end of life options are available [including hospice care and pain management].

So if, as a nurse, you live in a state without a [MAiD] law, and someone asks you about it, [best practice] is taking a moment to really focus on that person and that request and ask: What does this mean to you? What does that request mean to you? Do you understand what all your options are for care at the end of life, and that we live in a state that does not have a law?

Then, if [end-of-life medical assistance] is important enough to patient, they [might consider if they’re willing] to move to a state with a law? This is a very big question. At the end of a person’s life, that is a really big step: to decide to pull out roots from their community, their community of support, and their healthcare community of support, and move to another area, to go through the process of establishing residency–depending on where you're living—and finding 2 doctors who will participate in this program [is a big commitment].

However, some will decide that it is important enough to them and they do want to do that. But others [will not] and so everyone needs to understand what end-of-life care options are available to them. It is important to have that full conversation to understand that their personal beliefs, values, and goals are, and to see what types of care match their needs, as well as what is available in their community.

What are some misconceptions or things that nurses may not understand about MAiD that makes it difficult for them to support it?

A lot of times [individuals] do not understand [how it is] a self-directed process. This is the patient who wants this and it is vital that they determine what the end of their life looks like.

I remember a person who said, “When I got this diagnosis years ago, I knew that my treatment options would probably run out at some point. So, I became a partner with my health care team in making medical decisions moving through the course of my illness—I made decisions on what type of treatments [I took], what surgeries, and everything else that was possible.” When it came time for [the health care team] to say, there are no longer treatments for you, [the patient] said, “I made all of those decisions as a partner up to that point, why would it change?”

the ethical value of medical aid and dying and the impact that it does have on the patient.

I think that concept of autonomy and self determination to some [individuals] is paramount. Its who they are. They want partners in their health care [team] who will work with them to provide that care. Some health care providers also believe that providing compassionate care is one that meets the [patient's] goals.

Ultimately, the concept of suffering is for the patient to determine, not for us to judge.

Until we get to know these [individuals] and fully [understand] why they are making these requests [we cannot fully understand their needs]. Whatever a patient’s definition of suffering is, compassionate care means granting their requests to manage it.

Death with dignity act. Oregon Health Authority. Accessed June 1, 2022. bit.ly/390VQW4

Lisa Vigil Schattinger, MSN, RN, discusses her experience with medical aid in dying, and what oncology nurses need to understand when supporting patients at the end of their lives. 



What Oncology Nurses Should Understand About Medical Aid in Dying 

Addressing access to care is the first steps to improving patient outcomes, according to investigators with Yale Cancer Center and Moffitt Cancer Center. Ensuring that patients reach the right providers at the right team is key in being able to provide potentially life-saving agents and personalized treatments.

“Access is a multifaceted construct. It’s not just about the onboarding process or the amount of time that it takes to get that first appointment. It also ensures that the patient can reach a live person when they make a phone call, that they can be seen in a convenient location be seen by a clinician who is an expert in their specific disease, that they [can] access information about their diagnosis that’s readily available, and be able to afford their care,” Sarah Mougalian, MD, said during the 2022 National Comprehensive Cancer Network (NCCN) Annual Conference.

 She added that treatment should not only be prompt, but also have seamless transitions from the first appointment through every phase of the cancer care continuum. Mougalian is chief ambulatory officer at Yale Cancer Center/ Smilow Cancer Hospital and an associate professor of medicine in medical oncology at Yale School of Medicine in New Haven, Connecticut.

Sustainable care following the first point of contact the management of logistics of care affects both the patient and the provider. “The moment that one has a diagnosis [of cancer], they are overcome with a sense of fear and urgency,” Christie Pratt, MA, DHSc, said on a panel at the 2022 NCCN Annual Conference. “At that moment both patients and their loved ones need help. It’s about more than just getting them to the best care. It’s deeper than that,” Pratt is the senior director of Moffitt Medical Group at Moffitt Cancer Center in Tampa, Florida.

Data from a recent meta-analysis of mortality rates across the most common cancer types— bladder, breast, colon, rectum, lung, cervix, and head and neck—demonstrated that delays in cancer treatment initiation were associated with increased risk of death if delayed by 4 weeks or more.2 For example, a 13% increased risk of death was associated with a 4-week delay in adjuvant systemic treatment for patients with colorectal cancer.2 Hazard ratios for delays in systemic treatments had singificant associations with delays of 4 weeks in neoadjuvant treatment of bladder cancer (HR, 1.24; 95% CI, 1.03-1.50), adjuvant treatment of breast cancer (HR, 1.09; 95% CI, 1.07-1.11). Additionally, radiotherapy delays in head and neck cancer (HR, 1.09; 95% CI, 1.05-1.14) and cervical cancer (HR, 1.23; 95% CI, 1.00-1.50) were deemed significant.

Investigators cited patient, disease, and system factors all play a role in delays to care, the most cited reasons being workups and specialist consultations. To alleviate the burden of even one of these factors could significantly improve delays in treatment.

Mougalian and Pratt presented 2 initiatives to improve new patient access to cancer care at Yale Cancer Center/Smilow Cancer Hospital and Moffit Cancer Center, respectively.

 The programs focused on systemic hurdles, namely reducing delays for patient appointments with disease specialists.

Developing a system with a patient-centric focus, investigators at Yale Cancer Center initiated a pilot program to offer patients next day access to care following a diagnosis of cancer. Mougalian and her colleagues began with 2 subspecialty clinics at the institution—breast and gynecologic oncology. “We want it to be easy [for the patient following their] initial consultation to self-refer [and] for the scheduling process to be efficient,” Mougalian said. “We want the patient to be able to see a provider who is expert in their diagnosis in a timely fashion or institutional goal is within 5 days. Both before and after the first appointment, the patient should be able to speak with someone knowledgeable in the process and understanding of the plan of care.”

Investigators in the breast and gynecologic clinics were tasked with developing individual implementation plans that included an algorithm to define which patients were eligible for next day access (

). Selected patients typically included those who had received a diagnosis of cancer or suggestion of cancer prior to referral. The institutional goal of the pilot program was to have patients obtain appointments within 5 days. Early findings of the program were presented at the 2021 American Society of Clinical Oncology Quality Care Symposium.

The analysis included 3107 new patients who had a referral meeting across 4 sites of the institution. The primary efficacy measures of the program were to evaluate the number of patients who were seen within 1 business day of their referral, time to their first visit, the number of patients who accepted a next day appointment, and to obtain a descriptive analysis of the reasons why a next day appointment was not taken. Among the entire population of patients seen, 900 were eligible for next day visits with 12% of patients accepting the appointment. More patients with breast cancer (17%) accepted next day visits than those who received a diagnosis of gynecologic cancer (9%).

The median time to first visit was measured at 2 time points: December 2019 through February 2020, and December 2020 through February 2021. The median time to next visit in the first year was 13 days vs 9 days in the second year.

Mougalian stressed the importance of care team coordination through the process. “For providers who refer to us, the process should also be seamless and efficient,” she said. “Appointments should be scheduled quickly and follow-up and notes from the first consultation should be relayed back to the referring physician.” Mougalian added that special attention should also be paid to internal staffing challenges with even distribution of patient cases among appropriate specialists within the disease state. “Each team reviewed historical data to estimate the volume of new patient slots [and] made the appropriate adjustments in scheduling,” she said.

In contrast with their internal goal, investigators also strived to meet patient where they were. “The patient was at the center of this initiative and the No. 1 goal was to honor the patient’s choice, offering an appointment as soon as the patient wants it, and where the patient prefers,” Mougalian said. In tandem with this, she noted that managing patient expectations was also a critical component of the process, including the limitations that come with a next day appointment and other options that were available to them. An example roadmap for implementation is outlined in 

In an analysis of patients with a data cutoff of February 2021, reasons why patients did not accept a next day appointment included the availability of a specific provider (49%) or a specific date was requested (27%). These rates dropped in an analysis between August 2021 and January 2022 to 38% and 20%, respectively.

Overall patients were satisfied with their scheduling through the next day access program with 92% of respondents (n = 864) stating that they were satisfied with their appointment choices. Further, 67% said the appointments exceeded their expectations with 29% stating that the appointment met their expectations. “We also asked on a scale of 1 to 10: How would you rate your first visit? The average was 9.4, and the median was 10 [ range, 4-10],” Mougalian said.

Oncologist feedback was also collected during the process with some providers noting that the appointments often felt inefficient and harder to navigate, especially if they did not have a comprehensive snapshot of the patient’s records for clinical review. “In general, the feedback was positive, and it was [noted] that patient satisfaction [as well as] excellent responses from providers who referred [patients] was a market differentiator and was going to drive referrals going forward,” Mougalian said.

At Moffit Cancer Center, a similar program, First Connect, was initiated to establish care expectations for patients, enhance multidimensional approaches to care including access to clinical trials and personalized medicine, and improve access to visits with a 1-day turnaround from intake to appointment with a clinical subject matter expert.

 “The goal of First Connect was to not only create and provide patients with access, but [execute] it in a very meaningful way,” Pratt said.

The First Connect program starts with a call during which 3 main components are tackled: clinical assessment to support additional work-up requests and initiate a suspected clinical pathway; accelerate access to care by aligning the right provider with the right patient; and to build a foundational component with the patient. A key differentiator of the construct of the Moffit Cancer Center program is an increased focus on the emotional bond with the patient to help alleviate anxiety and build connections with the clinical team, Pratt said.

“The First Connect call is scheduled 24 hours after a patient has entered into our system,” Pratt said. “These calls are prior to a destination visit and serve as the connection that that patient can make with the clinic [and with] a provider who has the knowledge base about the disease can help set expectations. The most important piece is that the patient feels comfortable, understands, and is prepared for the destination visit.” In addition to establishing that connection, Pratt noted that these calls are aimed at patient retention. “Approximately 12% of patients who call into our system, get put into a queue to be scheduled, and then we lose them, they never complete a new patient appointment,” Pratt said. “And that could be because they cancelled the appointment or because we were unable to ever get a hold of them, or that they [were a no show]. We really wanted this to be a way to make that connection and let the patient know, we care, we want to begin the process, and start collecting records to show you that we’re invested in your care and getting you to that consulate visit to start the journey.”

An important component of the pilot program is also generating an increased awareness of the institution’s offerings. “We want to make sure that we market to providers, so that if you’re [a clinician] who’s messaging to your patients is that their cancer diagnosis is your top priority, we now offer the opportunity to speak to a cancer expert within 1 day,” Timothy A. Price, MBA, FACHE, director of patient access at Moffitt Cancer Center said.

Overcoming Barriers to Implementation and Care

Operational and cultural barriers present hurdles for both referring physicians and institutional teams to overcome. Multilevel problems are affecting diversity in clinical trial enrollment from a patient, health system, provider, and community aspect. Should the pilot programs reach the community in their intended ways, increased engagement between providers and referring clinicians may open the door for improved institutional infrastructure across sites to promote enrollment and recruitment. Although the changes may be minimal at this level, these programs afford the treating institutions data sets they did not previously have access to.

“These [programs are] important for the organization because they become a very rich data set,” Price said. “Really understanding patient preference and what’s actually happening with our scheduling data, [we can] harness the power [and] leverage that information for modality planning and looking at our clinical pathways for developing better clinical trial matching.”

Both Price and Mougalian drew attention to turnover and staffing issues which may affect the consistency of these programs to meet their objectives. “We saw that the number of available slots declined over time to and that we largely attribute to faculty departures,” Mougalian said.

“For us, from a [registered nurse] RN perspective, across the nation we have nursing challenges,” Price said. “They have clinical responsibilities [so we must] monitor to see if it is still appropriate delegation of responsibilities knowing some of the constraints that the departments. We wanted to call this out because post pandemic we have seen a rise in calls. How do we deal with those volumes?” One avenue Price noted is maintaining the high-quality call and providing training to get the most out of the interaction and establish that meaningful connection.

“We really need to be thinking about the capacity and the scalability of this,” Price said. “We need to take a look at how they manage their clinical duties and making sure that they’re getting credit for the work that they’re doing.”

Mougalian agreed noting that the minimum data that a patient and the referred physician receive prior to the first appointment should be meaningful. “The team should work together to ensure that the patient understands the plan of care that follow-up is established and that the patient is satisfied with the interactions, the process, and the care that’s delivered,” she said.

“There is no silver bullet for access,” Price said. “We really need to be doing things that have an upstream effect and [can change] the system.”

Mougalian S, Pratt C, Price TA. Strategies and initiatives to improve new patient access to cancer care. Presented at: 2022 National Comprehensive Cancer Network Annual Conference. March 30-April 2, 2022; Accessed May 3, 2022. bit.ly/3wj3RgH

Hanna TP, King WD, Thibodeau S, et al. Mortality due to cancer treatment delay: systematic review and meta-analysis. 

Mougalian SS, Shomsky L, Campos MM, Chiang AC. “The waiting is the worst”: development of a next day access (NDA) program for patients with cancer. 

. 2021;39(suppl 28):205. doi:10.1200/JCO.2020.39.28_suppl.205

This article was originally published on 

 as “New Programs Unlock Patient Access to Oncology Care.”

Pilot programs based out of Yale Cancer Center and Moffitt Cancer Center seek to improve access for newly diagnosed patients with cancer. 



New Strategies Provide Faster Access To Cancer Care For Patients

Often, when a patient arrives at the clinic to begin cancer therapy, they may be too anxious to fully comprehend what their nurses is explaining to them about their treatment, according to Heather Kennihan, MSN, RN, OCN, a professional development specialist with the AHN Cancer Institute.

Yet, same-day treatment education is common practice at many institutions, she said.

“Our practice [used to teach] the patients about their treatment the day they started,” said Kennihan. “They would sit in the chair, start getting their port access, and [the nurse would] tell them about their treatments, their side effects, and explain why they were getting this treatment.”

However, Kennihan was reading literature that showed that patients had anxiety levels during that time. Furthermore, she noticed their anxiety firsthand. “I was a nurse navigator for about 8 years: I saw a lot of the anxiety that they had prior to treatment,” she said.

In 2017, Kennihan helped roll out a “pre-teach” program. Through this initiative, she would connect with patients either by phone or through a separate appointment to discuss their treatment before they came into the clinic.

Around the same time, Kennihan’s colleague was working on addressing another gap in patient education: in survivorship care. In 2019, Nicole Kulasa, RN, OCN, joined the AHN nurse navigation team to help them reach accreditation standards for the Commission on Cancer (COC) and Quality Oncology Practice Initiative (QOPI) survivorship care plan criteria. The institution sought to expand services beyond just delivering a survivorship care plan which also coincided with CoC changes for survivorship program resources.

“There is a lot of fear with a cancer diagnosis and treatment. But the more knowledge and education they have in the role they play in their care and involvement, empowers the patient and helps allievate some of the fear.. That is the same in posttreatment, which can also be scary,” said Kulasa.

To help patients alleviate this fear, the survivorship team scheduled patients for a 60-minute post treatment appointment to discuss their survivorship care plan and potential long-term side effects.

“We say: ‘This is what's your follow-up should be.’ Then, ‘These are the tips that you should [take] to look forward to a healthy future and decrease the chances of cancer recurrence,’” she shared.

Both Kennihan and Kulasa recently met with 

® to discuss these “pre-” and “post-teach” initiatives. Throughout the discussion, the 2 oncology nurses explain how the programs came about, navigating COVID-19 and key patient treatment education takeaways.

“I actually started doing a “mock pre-teach’ before we really were [standardizing] it,” Kennihan said. “A lot of times, I would spend time with the patient over the phone for about a half hour to an hour describing to them what to expect [with their treatment], and what their side effects may be. It seemed to provide them that opportunity to ask questions.”

Kennihan’s team put a formal process together in 2018. This process included not only a nursing in the “pre-teach” proves, but also a clinical pharmacy specialist and ana advanced practice provider. They wanted to include all 3 disciplines in this pre-teach appointment. Patients were asked to come in for a separate appointment prior to treatment to meet with all 3 specialists at once.

The institution also issued patient surveys and found that most of their patients responded well to 1-on-1 education and reading. This knowledge helped guide their pre-teach plan, as well.

“At first, we initiated in just a couple of [our] offices,” Kennihan said. “Kind of like a pilot. We [eventually] rolled it out to all 17 locations. It took all of 2019 to really get everyone involved, and really get everyone on board to participate: there is a lot of staff to educate, and a lot of processes to streamline.”

By 2020, the institution was turning its attention to survivorship. Together with an advanced practice provider, Kulasa helped develop a survivorship clinic, serving as nurse navigator.

“AHNCI had successfully implemented a process of a ‘pre-teach’ education session prior to patients starting treatment, in the survivorship clinic we addressed ‘post-teach:’ a treatment education session as a survivorship visit,” Kulasa said.

The post-teach session was a 60-minute appointment, in which the care team addressed how cancer had affected a patient and the resources needed to help navigate those physical and emotional side effects. The team would discuss health and wellness, nutrition, exercise, other preventative cancer screenings, and more, with the objective of providing patients with the tools to help them find their new normal.

Both teams dedicated many hours problem-solving when COVID-19 broke out in 2020. There was a lot of uncertainty.

Ultimately, the pre-teach team decided to move to telehealth and telephone offerings. However, they felt that was a lot less effective for patients, so the nursing team found ways to supplement the telehealth experienced.

“Our nursing staff and our clinical pharmacy team would call the patients on the phone after the meeting,” said Kennihan, adding that they would also send them written materials and resources as well.

As soon as they were able, the team reinstated in-person pre-teach sessions again. Although they had to limit the number of visitors, they allowed 1 caregiver to accompany their patient—even though caregivers weren’t allowed to come in for treatment itself.

“We felt that it was really imperative to have that caregiver with them, because we found that, oftentimes they are the ones asking more questions than the patients themselves.”

Unfortunately, the post-teach survivorship visits were starting in 2020, right when COVID-19 arrived.

“Starting a new program that hasn't been established before is obviously very challenging.,” Kulasa explained. “[Factoring in] the pandemic [was challenging] because we are asking patients to come into the center. The patients did not want to come into the centers for additional appointments.”

Similar to the pre-teach team, the survivorship team offered visits through telehealth or over the phone. They would also mail resources out to patients or send them electronically through “my chart.” However, they also felt that the lack of in-person visits was unfortunate. 

To circumvent these issues, the clinic became more “nurse navigator and survivorship champion” driven.

On top of [these challenges], we had staffing changes as well. Now, we're [shifting] the survivorship clinic to [become] more survivorship champion driven:

Kulasa explained: “A patient who is finishing treatment is referred to the nurse navigator, who then calls and speaks with the patient, goes over the care plans, and then [connects] them up to [available] resources, such as support groups and virtual classes.”

In this way, the survivorship clinic was able to get off the ground, despite the challenge of COVID-19.

Two oncology nurses with Allegheny Health Network discuss how they guide patients through their diagnosis, treatment, and life after cancer.

Nurse Navigation

Nurse Navigators Can Help Alleviate Medical Distrust, Improve Clinical Trial Enrollment

Geriatric Assessment Rates Improve With Nurse Navigator Intervention

Black Patients With Metastatic Breast Cancer Experience More Hesitancy With Clinical Trial Enrollment

The Basics of Biosimilars for Oncology Nurses

What Oncology Nurses Should Understand About Medical Aid in Dying

New Strategies Provide Faster Access To Cancer Care For Patients

The Power of Knowledge: Implementing “Pre-” and “Post-Teach” Sessions into a Cancer Treatment Plan

Electronic Health Record Notes May Be Perpetuating Biases

Childhood Cancer Survivors Likely to Deliver Healthy Babies, But May Require Additional Monitoring During Pregnancy

Cyropreservation Continues to Improve Fertility Options for Patients with Breast Cancer