ACORI Research Review: September 2023

Nursing research is a systematic inquiry conducted by nurses to develop knowledge and improve the quality of nursing practice. It involves the scientific investigation of nursing phenomena, issues, or questions related to patient care, nursing education, nursing administration, and nursing policy. Nursing research aims to generate evidence-based knowledge that can guide and enhance nursing practice, education, and policymaking.

Here are some key characteristics of nursing research:

• Focus on nursing practice. Nursing research primarily addresses questions and issues specific to nursing care, such as patient outcomes, nursing interventions, and the impact of nursing practice on patient well-being.
• Patient-centered approach. Nursing research emphasizes the experiences and perspectives of patients, focusing on understanding their needs, preferences, and responses to nursing care.
• Holistic perspective. Nursing research often takes a holistic view of patient care, considering the physical, psychological, social, and cultural aspects of health and well-being.
• Emphasis on nursing interventions. Nursing research explores the effectiveness and impact of various nursing interventions, such as medication administration, patient education, therapeutic communication, and the use of technology in nursing practice.
• Practice-oriented outcomes. Nursing research aims to produce evidence that directly informs and improves nursing practice, education, and policy. The findings are often translated into practical guidelines and recommendations for nurses.

While nursing research shares similarities with medical research, there are notable differences between the two:

• Scope and focus. Medical research encompasses a broad range of scientific investigations related to disease prevention, diagnosis, treatment, and understanding human biology. It involves various disciplines, including basic sciences, clinical medicine, and epidemiology. Nursing research, on the other hand, specifically concentrates on questions and issues relevant to nursing practice and patient care.
• Perspective. Medical research typically takes a disease-centered approach, focusing on understanding and managing specific health conditions or diseases. Nursing research adopts a patient-centered perspective, considering the experiences, needs, and responses of individuals in the context of nursing care.
• Research questions. Medical research often explores questions related to disease mechanisms, drug development, treatment efficacy, and diagnostic techniques. Nursing research, while it may incorporate these aspects, also investigates questions concerning nursing interventions, patient outcomes, and nursing practice improvement.
• Methodologies. Both medical and nursing research employ scientific methodologies such as experimental designs, observational studies, surveys, and qualitative approaches. However, nursing research often places particular emphasis on qualitative methods to explore subjective experiences, patient narratives, and the social aspects of health and care.

Overall, nursing research complements medical research by focusing on the unique contributions of nursing practice to patient care and well-being. It helps build an evidence base that is essential for advancing nursing knowledge, improving healthcare outcomes, and shaping nursing policies and interventions. While nursing research and medical research have distinct focuses, they are interconnected and complementary in the pursuit of better patient care and improved health outcomes. Collaboration between nursing and medical researchers is essential for comprehensive advancements in the field of healthcare.

Cancer nursing research is a specialized field of study that focuses on investigating various aspects of cancer care and nursing interventions to improve patient outcomes. It involves conducting research studies, collecting data, and analyzing findings related to cancer nursing practice. The ultimate goal is to enhance the quality of cancer care, promote evidence-based nursing interventions, and contribute to the advancement of knowledge in the field of oncology nursing. Cancer nursing research covers a wide range of topics, including but not limited to:

• Symptom management. Research aims to explore effective strategies for managing cancer-related symptoms such as pain, nausea, fatigue, and psychological distress. This includes investigating the use of pharmacological and non-pharmacological interventions to improve symptom control and patients' quality of life.
• Supportive care. Studies in this area focus on identifying the supportive care needs of cancer patients and developing interventions to address those needs. This may involve evaluating the effectiveness of psychosocial support, palliative care services, survivorship programs, and patient education to enhance patients' well-being throughout their cancer journey.
• Nursing interventions. Research is conducted to evaluate the impact of various nursing interventions on cancer patients' outcomes. This includes examining the effectiveness of nursing protocols, care models, and evidence-based practices in areas such as chemotherapy administration, radiation therapy, surgical care, and symptom management.
• Patient education and self-management. Studies in this area aim to assess the effectiveness of educational interventions and self-management programs in empowering cancer patients to actively participate in their care. Research may focus on developing educational materials, evaluating interventions to improve health literacy, and promoting self-care behaviors among cancer patients.
• Survivorship and quality of life. Research explores the long-term effects of cancer treatment on survivors and interventions to improve their quality of life. This may involve investigating survivorship care plans, rehabilitation programs, and strategies to address late effects of treatment, psychological well-being, and social support for survivors.
• Nursing workforce and practice. Research in this area examines the impact of nursing staffing levels, nurse-patient ratios, and nursing workload on cancer patient outcomes. It also explores the role of oncology nurses in delivering high-quality care and the factors influencing their job satisfaction and professional development.

Cancer nursing research plays a crucial role in advancing evidence-based practice and improving patient care. The findings of research studies help guide clinical decision-making, develop guidelines and protocols, and inform policy decisions related to cancer care. By generating new knowledge and promoting best practices, cancer nursing research contributes to improving the quality of life and overall outcomes for individuals affected by cancer.

References

Polit DF, Beck CT (2017). Nursing Research: Generating and Assessing Evidence for Nursing Practice. Tenth Edition. Wolters Kluwer, 2017.
Burns N, Grove SK. Understanding Nursing Research: Building an Evidence-Based Practice. Seventh Edition. Saunders, 2017.
Creswell JW, Poth CN. Qualitative Inquiry and Research Design: Choosing Among Five Approaches. Fourth Edition. Sage Publications, 2018.
Holloway I, Galvin K. Qualitative Research in Nursing and Healthcare. Fourth Edition. Wiley-Blackwell, 2016.
LoBiondo-Wood G, Haber J. Nursing Research: Methods and Critical Appraisal for Evidence-Based Practice. Ninth Edition. Mosby. 2017.
Munhall PL. Nursing Research: A Qualitative Perspective. Fifth Edition. Jones & Bartlett Learning, 2012.
National Institute of Nursing Research. 2022-2026 Strategic Plan. Accessed August 2, 2023. https://www.ninr.nih.gov/sites/files/docs/NINR_One-Pager12_508c.pdf

To raise awareness about the significance of global cancer research, every year we celebrate World Cancer Research Day on September 24. Initially launched in 2016 by a collaboration of cancer organizations around the world, this campaign seeks to promote cancer research around the world and improve survival and quality of life for patients with cancer. For 2023, the theme is “Cancer Research Works: Driving Progress Together.” Those who wish to support the cause can sign the World Declaration for Research on Cancer, which symbolizes commitment to the following goals by 2025: “increase awareness about the value and impact of cancer research efforts; enhance sustainable funding sources for research in each country; promote international collaboration; provide training in cancer research; and encourage the development of infrastructures for research in each country.” Thus far, more than 608,000 people, 130 entities, and 12,600 researchers have signed the Declaration.

On September 24, participating individuals and organizations can endorse the campaign by sharing on their websites and social media and posting to the World Cancer Research Day pages. The global cancer burden is too heavy to bear individually—or even regionally; we must come together as a global society to improve care for all. In the words of the World Cancer Research Day Call to Action, “joining global efforts toward a common goal to control cancer will allow more people to live without cancer, and more patients with cancer to be diagnosed earlier, suffer less, respond to treatment, and have a better quality of life during and after treatment.”    

It is important not only to identify patients with oligometastatic disease who may be candidates for more aggressive treatment for potential cure but also to follow these patients long-term to gauge their overall survival and quality of life. Because oligometastatic breast cancer represents only a small subset of patients, much remains unknown about this rare population. Can these patients truly be cured if we apply multimodal treatments to them? How aggressive should we be in our treatment of oligometastatic breast cancer? What leads some patients with oligometastatic disease NOT to pursue certain treatments? How is the long-term quality of life for these patients?

Dr. Mariya Rozenblit, a breast oncologist at the Yale Smilow Cancer Hospital, is hoping to answer these questions and more in her new study entitled “Can We Cure Oligometastatic Stage IV HER2+ Breast Cancer with Multimodality Therapy?” The recently-launched CHLOE study is a prospective online registry trial investigating long-term outcomes of a multimodal neoadjuvant followed by adjuvant therapy approach in patients with de novo oligometastatic HER2+ breast cancer. Any patient with newly diagnosed oligometastatic HER2+ breast cancer is eligible for the registry; there are no specific laboratory parameters or performance status criteria that must be met, in hopes of capturing as wide an audience as possible. It is worth noting that patients with de novo oligometastatic HER2+ breast cancer who have already started down their curative treatment path can still be enrolled into the registry; there is no set cut-off point within a patient’s treatment journey that would exclude them from participation.

To participate in the registry, physicians or patients can enter their information into the “Contact Us” section of the webpage, after which they will be contacted by Dr. Rozenblit’s team for more information. Once a patient is ready to enroll, Yale will reach out to the patient via telephone to consent them (there is also an electronic form), and then the provider will be set up with a login and password for the online portal. Upon logging in, the provider will see a short baseline questionnaire to collect information about the patients’ cancer and demographics. After providing this information, the provider will be presented with a recommended treatment schema employing neoadjuvant anti-HER2-directed therapy, surgery, radiation, and adjuvant/maintenance therapy. The overarching idea is to implement as many of these modalities as possible, but each provider can choose the specifics such as chemotherapy regimen or radiation dose.

Three months after the initial questionnaire, providers will receive an email to log back into the portal and enter information regarding the patient’s treatment progress. Thereafter, providers will receive a reminder email every 3 months to re-enter the portal and answer a short survey comprised of 5 to 6 multiple-choice questions about the patient’s treatment, such as “Was the patient able to complete treatment? If not, why?”; “Did they undergo mastectomy?”; “What was the full dose of radiation that the patient received?”; “Where are the sites of metastases?”. If, at any point during the process, the patient does not undergo a specific modality of treatment, they would remain on the registry to gather more information about the treatment decisions. The goal of the CHLOE study is to compile real-world data about the treatments and outcomes of oligometastatic breast cancer and if that includes cases in which not all modalities are explored, then the authors want to know the rationale behind those decisions. After completion of treatment, providers will continue to receive short surveys to follow-up on long-term outcomes (i.e., questions such as “Was there progression? Is the disease still stable?”). Patients will be followed for at least 2 years.

One important aspect of the CHLOE study is that it also focuses heavily on patient experience. Randomized controlled trials often forgo quality of life data, but a long-term registry trial can be an effective method for collecting this information. In addition to provider surveys, patients will also receive surveys (every 6 months) assessing their quality of life and global health. Attaining quality of life data for this patient population will be invaluable as we want not only to cure these patients, but to cure them well. A registry trial also allows the opportunity to account for patient preference in treatment decision-making. If a patient did not want to undergo a specific component of the treatment plan, then the study wants to know—why is that? What are the factors impacting a patient to choose one option over another? The ability to investigate these questions in a registry study gives insight into the data beyond what randomized clinical trials can typically provide.

The CHLOE study has the potential to uncover vital information regarding long-term outcomes for this rare cancer population. However, to capture as diverse a patient population as possible, the study is relying heavily on participation from community oncologists across the country. Since most oncology patients are managed in the community setting, it is important to include a wide variety of community patients to ensure generalizability of study results. Moreover, because de novo oligometastatic breast cancer is rare, a wide net must be cast to recruit enough patients for meaningful and robust results. The study hopes to enroll at least 40 patients over a 1.5 to 2-year period; Dr. Rozenblit strongly encourages all community oncologists to consider enrolling appropriate patients. Community oncologists are critical to the success of clinical research, especially for a registry trial hoping to provide valuable real-world data. For more information or registration, providers can visit the CHLOE study website. 

In this study, community providers noted that the available clinical trials often do not match the disease types, stages, and goals of patients treated in the community. Whereas academic trials are often in the third-line or beyond setting, community cancer programs typically need more adjuvant or first-line options. Moreover, strict eligibility criteria tend to bar many community patients from being able to participate, even if they wanted to. From a system’s perspective, providers felt that their community programs lacked sufficient research support to be able to carry out the trial properly. Having only a few research staff in the program can pose a significant barrier, even more so when the physicians themselves may not have in-depth knowledge of the trials.

Lack of physician specialization was seen as another major obstacle to community research; specialized oncologists in academic settings are often more aware of available trials, more knowledgeable about trial details, and more efficient overall at being able to offer trials. One physician commented, “in the community…our practice is so busy, it takes time to investigate whether the patient is eligible, or if there is a potential clinical trial for the patient, [and hence] there is a temptation to use standard-of-care treatments without necessarily exploring clinical trial options”.

Despite these perceived barriers and more, one community cancer center sought to pilot a phase 1 clinical trial in the outpatient setting during the pandemic. Pennsylvania Hospital, a privately-owned hospital that is part of the University of Pennsylvania’s Abramson Cancer Center network, operates like a community cancer program where providers manage all oncologic diseases. Pennsylvania Hospital has been running phase II and III trials for years as a hospital disease team. The transition to running phase I studies, however, was a big step because such trials had always been conducted under specialized disease teams within the academic institution.

To start the phase 1 process, physician leadership identified appropriate trials to match the program’s patient population and skill set. Mandatory research meetings were implemented to ensure adequate physician oversight of all patients. Within 6 months of opening its first phase 1 trial, Pennsylvania Hospital was acknowledged by the sponsor for being the highest accruing site nationally. In 1.5 years, the hospital enrolled more than 60 patients to phase I trials. It has since opened more phase I trials and have seen a substantial increase in non-phase I trials as well. Ultimately, Pennsylvania Hospital’s success shows that phase I trials can be safely and successfully conducted in the community setting.

A detailed review of this innovative research program will be presented at the ACCC 40th National Oncology Conference  from October 4 - 6 in Austin, Texas. The session will highlight how to engage non-academic track physicians in research and how to operationalize clinical and business operations to create and sustain a successful research program. The meeting will feature a variety of innovative programs and strategies that streamline operations, address workforce issues, and improve the patient experience, among other topics. Other research-focused projects to be exhibited include “Use of Technology to Streamline the Tumor Board Workflow and Support Clinical Trial Matching” and “Inclusive Demographics for Research: Supporting the Equitable Selection of Subjects.” Register for the meeting here.

The goal of creating Let’s Win was to establish a unique online community where patients and providers alike could come to share and learn more about pancreatic cancer. Let’s Win is dedicated to promoting innovation and patient empowerment in pancreatic cancer. What started as a small blog website has grown into a tremendous platform with more than 700 stories contributed by patients, medical professionals, and various institutions. Let’s Win features different sections on its website that encompass all areas of pancreatic cancer, including “Symptoms”, “Treatments”, “Disease Management”, “Research”, and “Survivor Stories.” Each section leads to an array of articles tailored to patients and the general public that aim to educate, inform, and empower patients to be in control of their care. In particular, the “Research” section features pieces discussing novel discoveries and open trials in hopes of piquing interest and empowering patients to ask their providers about other options. This section also serves as a great resource for community oncologists who may not have the time to research a myriad of clinical trial options on their own; instead, they can access the “Clinical Trials” subsection to read about ongoing trials. There are also educational webinars for patients and caregivers, such as “The Importance of Clinical Trials” and “Treatments and Clinical Trials.”  

Perhaps most impactful to patients and families is the section about “Survivor Stories.” In this space, patients and caregivers share their stories about battling pancreatic cancer, from suffering through symptoms and side effects (“Reeducation Myself about Pancreatic Cancer”) to advocating for themselves and loved ones (“Advocating for My Husband Has Made the Difference”, “The Benefit of Being Your Own Advocate”) and learning to cope (“Using Humor to Face Pancreatic Cancer”). A cancer journey may often feel lonely, but these narratives can help to encourage and inspire those fighting pancreatic cancer to persist and pursue through the journey. Let’s Win has transformed the lives of many patients with pancreatic cancer, providing a unique space where the patient and provider experience can intersect to enhance care for all.

Dr. Hala Borno, a medical oncologist at UCSF specializing in urologic cancers, realized early on in her career that clinical trials were only serving a subset of patients and not representing the vast majority of those battling cancer in this country. After a decade of gathering evidence on how to best combine technology with human authenticity to increase access to clinical research, Dr. Borno created a provider-facing platform called Trial Library that helps community providers offer trial opportunities to patients. Trial Library works by efficiently matching patients with trials, reimbursing providers for their pre-screening efforts, assisting patients in overcoming barriers to trial participation, and serving as the liaison between community practices and trial sites. Whether the program is a small independent practice with no research capability or a larger community network with ongoing trials, there is a role for Trial Library.

To get started with Trial Library, providers can register their program or practice on the website and invite other members to join as users. Once a user logs into their account, they will be able to review opportunities to pre-screen their patients for sponsored clinical trials. A sponsored clinical trial in the Trial Library database means that providers can submit a claim to be reimbursed for their screening efforts. Trial Library is primarily funded by study sponsors who want to ensure that the characteristics of patients enrolling onto studies are reflective of patients who have the condition. Thus, sponsors are motivated to partner with Trial Library to accelerate and expand recruitment.

Just recently, however, Trial Library has launched a more expansive library to include all therapeutic trials listed on clinicaltrials.gov within the colorectal, lung, thoracic, and breast disease areas, with future plans to build across all tumor types. Note: only sponsor-funded trials will be eligible for reimbursement claims at this time. Because Trial Library is a database for studies, community programs and practices that already have research capability may use Trial Library to learn about potential trial opportunities to activate at their own sites. Ultimately, Trial Library serves as infrastructure to help enhance overall research capacity in the community setting.

How to Use Trial Library

Once provides select a trial for which to pre-screen, they will be able to see trial details and eligibility criteria and will have to commit to pre-screening all patients in their program or practice for that specific trial for a minimum of 3 months. For programs that do not have the capacity to pre-screen on their own, Trial Library can also provide pre-screening services through its Clinical Data Coordinators, who—with access to the program’s medical records—can help identify eligible patients. If a patient is deemed suitable for a particular trial during the screening process, then a member of the community treatment team is responsible for discussing the trial with the patient. If the patient elects to proceed with the trial, then the provider can refer the patient directly on the Trial Library platform.

Providers will also use the platform to submit claims for reimbursement for pre-screening efforts. It should be noted that reimbursement through Trial Library is solely effort-based, meaning that providers will be reimbursed for their time and effort even if they do not end up identifying any patients for the trial. The Trial Library team refers to this portion of the recruitment process as the “first mile”; trial engagement is lacking in community settings largely due to inadequate time and resources so by reimbursing providers for their pre-screening efforts, Trial Library can address some of the major provider-related barriers to research participation.

Providers, however, are only one half of the equation in research participation; to optimize trial enrollment, patient barriers must also be addressed. This half of the equation is known as the “last mile” at Trial Library. What sets this platform apart is its dedication to solving “last mile problems” by providing individualized services to help patients overcome barriers to trial participation related to food insecurity, travel, and lodging. Trial Library uses a social determinants of health (SDOH) framework to help identify appropriate resources for patients. In addition, many sponsors also provide resources (ie, travel reimbursement), but these resources are typically only available to patients who have already consented to a study, which means there is a gap in care for those who are not yet on study but want to be. Trial Library works hard at closing this—and other—gaps in patient enrollment. At Trial Library, the team members who help patients navigate SDOH barriers and apply for grants are called “Ally Navigators”; these individuals are non-clinical staff members who not only help patients logistically but can provide an empathetic touch throughout the entire process.

Furthermore, Ally Navigators also act as liaisons between the community practice site and the trial site. Often, when a patient is referred to another site, referring providers may lose track of the patient’s status, which can be risky in the case of a sick or unstable patient with rapidly growing disease. Trial Library’s Ally Navigators help provide consistent visibility to referring providers on the patient’s status throughout the trial. And Trial Library also understands the importance of patient retention—especially for small community programs that rely on strong patient-provider relationships—and makes it a priority to ensure that these core relationships are maintained.

Ally Navigator services are available for any patient referred to a study through Trial Library. To take advantage of these services, providers should select the option to allow Trial Library to contact the patient about navigation services, when filling out referral details. Of note, Trial Library will only contact a patient after the patient has been informed about the study by the referring team. The Navigator will then reach out to the patient via phone within 24 to 48 hours of referral from the provider.

Trial Library provides a unique solution to some of the most significant barriers to trial participation in community settings. Dr. Borno has previously published about the impact of combining a financial reimbursement program with patient navigation services and found that this type of model accelerated recruitment to cancer trials, particularly for late phase studies. Community oncology programs have—for the most part—long been absent in cancer research and it is time for the status quo to change. Trial Library is setting a meaningful precedent in today’s era of innovative technology and precision medicine: we have the tools to make a difference, and it is our responsibility to use these tools in a way that fosters equitable care for all patients.