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October 2013 VOL 4, NO 5
Category IV: Original Research
Thriving Again: Development of a Proactive Survivorship Program for Young Jewish Breast Cancer Survivors
Sharon Stahl, LMSW; Amy Mines Tadelis, Survivorship Program Supervisor
With the American College of Surgeons Commission on Cancer’s new accreditation standards calling for health- care professionals to provide survivorship care plans to all cancer survivors by 2015,1 there is a pressing need for useful tools and programs to be developed and implemented on a national level. With funding from the Centers for Disease Control and Prevention, Sharsheret developed and launched Thriving Again, a breast cancer support and education program to address the needs of young (diagnosed <45) breast cancer survivors that includes a survivorship care plan to be used by patients and their healthcare providers, as well as other critical survivorship resources.
In developing Thriving Again, we engaged in a year-long review and analysis of the survivorship field, conducting a national survivorship survey of more than 1700 young breast cancer survivors to better understand their unique needs and the identification of best practices and resources addressing survivorship needs. The data collected allowed us to identify the resources already available to young survivors and their priority unmet needs, and to create new resources as part of a comprehensive program to address their unique concerns. Thriving Again has reached more than 1000 young breast cancer survivors, and includes a survivorship care plan, psychosocial and genetic support for young breast cancer survivors, and critical survivorship resources.
Using Thriving Again as a model, there is an opportunity to develop similar programs that address the needs of young men and women facing other types of cancer. This presentation will offer strategies for developing a comprehensive, proactive survivorship program that includes a survivorship care plan that can help organizations and facilities meet the Commission on Cancer’s guidelines for survivorship. Specifically, an overview of existing care plans will be offered as well as guidance in the development of a national needs assessment tool, translating research on priority needs for specific populations into practical tools, creation and implementation of a comprehensive survivorship program, and educating survivors and families affected by cancer and the healthcare professionals who care for them.
1. Parry C, Kent EE, Mariotto AB, et al. Cancer survivors: a booming population. Cancer Epidemiol Biomarkers Prev. 2011;20(10):1996-2005.
The Effect of Survivorship Care Plans on Breast Cancer Patient’s Communication, Attitudes, and Self-Efficacy
Pamela J. Vetter, MSN, RN, OCN
Aspirus Regional Cancer Center
Background: The Institute of Medicine (IOM), in their report From Cancer Patient to Cancer Survivor: Lost in Transition, found cancer patients often lack the information they need to successfully navigate the transition from patient to survivor (2006). To assist patients in this endeavor, the IOM has recommended the use of a survivorship care plan (SCP) to help ensure patients are educated about their disease, side effects, necessary follow-up, and available resources, and are empowered to participate more in their care. The Commission on Cancer will soon be requiring SCPs for cancer programs to remain accredited despite a lack of research measuring overall efficacy. Objective: Determine if patients with breast cancer completing active cancer treatment who receive a SCP participate more in their care, maintain a more positive attitude, and are more knowledgeable about available resources than patients with breast cancer completing active treatment who do not receive a SCP. Methods: Patients with breast cancer completing treatment prior to and after SCP implementation were surveyed using a psychometrically sound tool, the Communication and Attitudinal Self-Efficacy scale for cancer, modified for survivorship. A pre-SCP survey was sent to all 24 patients with breast cancer who completed treatment in the 6 months prior to SCP implementation, and a post-SCP survey was sent to 28 of the 29 patients with breast cancer who completed treatment in the initial 6 months of SCP implementation. Results: Eight of 24 patients completed the initial survey (response rate [RR], 33.3%). In the post-SCP survey group, there were 16 respondents (RR, 57.1%). Post-SCP, all scores increased between 5.8% and 13.5%; the largest increases were seen in care participation and being able to request help. The smallest increases were seen in controlling negative feelings about cancer. Conclusions: The higher survey response rate post-SCP implementation may be due to patients having a better understanding of survivorship and therefore being more willing to complete the survey. The items showing the largest score increases are understandable, as they directly correlate with the purpose of the SCPs: communication and involvement in care, unlike maintaining a positive attitude, which was not a goal of SCPs, but perhaps a secondary benefit. The improved scores were encouraging; however, it was a small pilot project focusing on patients with breast cancer. It may be beneficial to perform a larger study to determine if the results can be replicated. Surveying patients diagnosed with other cancer types may also provide additional insight.
Nursing Implications Associated with Ibrutinib (PCI-32765), a First-in-Class, Oral Bruton’s Tyrosine Kinase (BTK) Inhibitor, When Used as a Single Agent in Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients (Pts)
Maria Badillo, RN, OCN, CCRP; Yiming Chen; Cynthia Jenkins; Michael Wang; Kristie Blum; Darrin Beaupre; Betty Chang; Mei Cheng; Susan King; Joanne Vanak; Weihong Chase
MD Anderson Cancer Center
Background: With single-agent activity in early clinical trials in relapsed/refractory mantle cell lymphoma (R/R MCL), ibrutinib, a first-in-class, orally administered Bruton’s tyrosine kinase (BTK) inhibitor, was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in February 2013. The new drug application was submitted to the FDA on July 10, 2013.
Objective: PCYC-1104, an international, multicenter, open-label, phase 2 study, evaluated the efficacy and safety of ibrutinib in patients with R/R MCL. One hundred fifteen (50/65) patients were enrolled and 111 (48/63) patients were treated; enrolled patients included those who had received prior bortezomib (BTZ) treatment (n=50) and patients with no prior BTZ treatment (n=65).
Methods: One hundred fifteen R/R MCL patients were enrolled; 111 patients received a fixed, once-daily oral dose of ibrutinib 560 mg. Treatment continued until disease progression or unacceptable adverse events (AEs) occurred.
- 110 patients who received ?1 ibrutinib dose and had at least 1 postbaseline assessment were evaluated for efficacy; median number of cycles was 9 (range, 1-24).
- With an estimated median follow-up of 15.3 months (range, 1.9-22.3), 46 patients were still receiving treatment.
- Most AEs observed were grade 1/2; the most common nonhematologic AEs were diarrhea (50%), fatigue (41%), and nausea (31%); the most common grade ?3 infection was pneumonia in 7 patients (6%).
- Grade 3/4 hematologic AEs included neutropenia (16%), thrombocytopenia (11%), and anemia (10%); grade 3 bleeding events occurred in 5 patients, with no grade 4 or 5 hemorrhagic events. Subdural hematomas were reported in 4 patients; all were associated with falls, head trauma, or both, and all 4 patients received either aspirin or warfarin within 2 days before or on the day of the event.
- An AE leading to discontinuation of therapy occurred in 8 patients (7%).
- The overall response rate (ORR) for all treated patients (n=111) was 68% (23 complete response [CR; 21%] and 52 partial response [PR; 47%]); the depth of response and the number of patients with CR increased over time; response to ibrutinib did not vary on the basis of baseline characteristics or the presence of risk factors.
- Estimated median response duration in responders (n=75) was 17.5 months (range, 0.0-19.6); median time to response was 1.9 months (range, 1.4-13.7) and median time to CR was 5.5 months (range, 1.7-11.5).
- Estimated median progression-free survival (PFS) in all treated patients was 13.9 months (range, 0.7-21.4); median PFS for subjects who achieved PR as a best response was 17.5 months, while the median PFS for subjects who achieved CR was not reached.
- At the time of publication, the median overall survival (OS) was also not reached; the estimated OS at 18 months was 58%.
- Independent Review Committee evaluation of the efficacy data demonstrated an ORR of 69% (21% CR; 48% PR) and median response duration of 19.6 months.
- 34% of patients exhibited a transient increase in absolute lymphocyte count (?50% increase from baseline and >5000 cells/mm3) during ibrutinib treatment, with a peak count at a median of 4 weeks after treatment initiation; elevated lymphocyte levels decreased substantially toward the end of cycle 2 and tapered off in cycles 4 and 5.
- Ibrutinib is a highly active new agent showing single-agent activity in R/R MCL.
- The favorable toxicity profile suggests that ibrutinib provides the opportunity for less intense and more effective treatment regimens than those currently available for MCL.
- Nursing implications include education about: (1) new mechanism of action, (2) reduction in lymph nodes with associated rise in absolute lymphocyte count (lymphocytosis), (3) adherence to oral dosing (taking on an empty stomach; drug–drug interaction with CYP3A4/5 inhibitors; avoiding warfarin and equivalent vitamin K antagonists), and (4) consulting with their oncologist if surgery is required.
- Nursing advisory board recommendations will be shared with nurse navigators who will be asked to help patients navigate the authorization process for this new oral oncolytic and identify sources for patient copay and other financial assistance.
Oncology Nurse Navigator Competencies: Providing Direction to Improve Care Delivery
The ONS Oncology Nurse Navigator Project Team; Lori McMullen, RN, MSN, OCN1; Teri A. Banman, RN, OCN2; Judy M. De Groot, RN, MSN, AOCN3; Susan T. Jacobs, RN, BSN, OCN; Dominique M. Srdanovic, RN, MA, OCN4; Heather Mackey, RN, MSN, AOCN5; Emily Franey5; Michele Galioto, RN, MSN5
1University Medical Center of Princeton at Plainsboro; 2The University of Kansas Cancer Center; 3Penrose Cancer Center; 4Roy and Patricia Disney Family Cancer Center; 5Oncology Nursing Society
Background: The American College of Surgeons Commission on Cancer recognized that patient navigation is an important component in the ability to deliver patient-centered care and has added Standard 3.1 to its Cancer Program Standards. Patient navigation has been identified as a process to address healthcare disparities and barriers to obtaining optimal care. To fulfill that standard, close the gaps on fragmented care, and address potential barriers to care, cancer programs around the country are instituting navigation programs. In many of these programs, oncology nurse navigators (ONNs) are filling the role secondary to their education- and disease-specific training. Data from the 2010 Advisory Board demonstrate that the role of the navigator is held by a registered nurse or advanced practice nurse in 75% of cancer programs. Using the nursing process, nurses in the role of navigator are able to assess for psychosocial, educational, and physical needs, thereby providing a valuable contribution to the multidisciplinary, patient-centered treatment plan. The challenges faced by many ONNs include a dearth of evidence-based resources, professional standards, or competencies to support them as they are being hired and charged with developing programs without the foundation tools needed to support their work. Objective: ONNs have looked to the Oncology Nursing Society (ONS), their professional organization, to provide leadership as they struggle with role development. Supported by data collected in the 2010 ONS Nurse Navigator Survey and antidotal information from the ONS Nurse Navigator Special Interest Group (NNSIG), ONS identified the need to clearly define the role of an oncology nurse in the role of navigator as well as support growth of the role by developing core competencies. Methods: A project team was assembled in August 2012. Starting with a thorough review of literature, the 7-member team met in November and began the process of clearly defining the role of the ONN. The team chose to work at developing core competencies suitable to a novice ONN, which is defined as an ONN with 1 to 2 years of experience. The literature review provided the evidence-based information necessary to develop a navigation framework that supports the ONN in her/his scope of professional practice. Within this scope of practice, the team divided the knowledge base and function of the ONN into 4 categories: professional role, education, coordination of care, and communication. These categories ultimately developed into a list of 47 ONN professional core competencies. To validate the competencies, a field review was conducted by members of the NNSIG. Reviewers were asked to determine if the competencies were considered core to the role of the ONN, were clearly written, and if they should be included as an ONN core competency. Reviewers were also asked for their input for competencies that were missed by the project team. A 29.2% response rate was realized. Following the field review, the team met to review each individual competency and make the necessary edits. Two competencies were deemed redundant by the field review and were subsequently dropped; 5 were combined to improve clarity, for a total of 40 ONN core competencies across the 4 categories. Ten expert reviewers were identified and agreed to complete a review of the ONN core competencies. These experts were chosen based on their years of experience and leadership role in oncology nurse navigation. The expert reviewers were asked to comment on the flow, clarity, completeness, and appropriateness of the overall competency listings, as well as to provide further feedback on individual statements. Based on their feedback, additional edits were made, and a final count of 40 core competencies were produced to define the role of ONN. Results: The core competency project has resulted in several essential tools for ONNs and their employers: ONN core competencies, an ONN professional practice framework, and a clear definition of the role. ONN competencies include the fundamental knowledge, skills, and expertise required to proficiently participate in the care of patients with a past, current, or potential diagnosis of cancer; assist oncology patients, families, and caregivers to help overcome healthcare system barriers; and provide education and resources to facilitate informed decision-making and timely access to quality health and psychosocial care throughout all phases of the cancer continuum. Conclusions: The competencies provide resources for both ONNs and their employers as they develop and grow navigation programs. To build on this momentum, the next step is to develop a nationally recognized education program to ensure that ONNs have the knowledge and skill set needed to function effectively in their role.
Conquering the Complexities of Navigating Oncology Veteran Patients
Sonya Curry, MSN, RN, ACNS-BC; Jennifer Smith, MSN, CNP
Department of Veteran Affairs Medical Center
Background: Oncology nurse navigators (ONNs) are essential for quality cancer care. A comprehensive electronic tool can facilitate the ONN’s delivery of coordinated and timely quality care across the disease trajectory. This is especially important for vulnerable patient populations such as veterans. The Veterans Affairs (VA) Healthcare System has implemented an electronic care management tool (CMT) that (1) tracks the veteran’s cancer care; (2) facilitates communication with the veteran, ONN, oncology team, and other healthcare providers; and (3) provides a mechanism to monitor veteran outcomes. Objective: To describe how an innovative care management tracking tool facilitates the role of the ONN and improves the quality and efficiency of cancer care. Methods: The VA ONN is the point of contact for the veteran, his or her family, and providers from the time of diagnosis and throughout the cancer trajectory. The navigation process begins with telephone contact between the veteran and the ONN. Veteran barriers (ie, transportation, financial burdens, child care, and access to outside medical records) that could potentially interfere with timely cancer care and adherence to the treatment plan are identified and addressed. The ONN’s intake assessment is documented in the CMT, which links to the electronic medical record. Automatic alerts for any additional testing needed for diagnosis and treatment planning are sent to the primary care provider and the oncology team prior to the first visit. This reduces the number of visits to the VA, which decreases financial and travel burdens for the veteran. Following the initial oncology clinic appointment, the ONN documents the treatment plan in the CMT and reviews it daily to ensure timely care. Results: More than 100 veterans in the oncology clinic have been entered into the CMT. The electronic tool has improved the navigation process. The oncology team is able to communicate daily with each other, ensuring continuity of care. Primary care providers appreciate that the tool allows them to be engaged in the patient’s cancer care. The percentage of veteran missed appointments has decreased from 11% to 6.2% as a result of nurse navigation and the support of the tracking tool. Conclusions: The CMT improves patient outcomes by providing an electronic mechanism for patient navigation and communication among oncology and healthcare team members.
Survivorship Navigation for Young Adults Shows Success
Maria Marek, MTS, BA, RN; Christopher Hamilton, MPH
Seton Cancer Survivor Center
Background: The Seton Cancer Survivor Center began an outreach to adolescent and young adult survivors aged 18 to 39 years in September 2011. Our goal is to improve the quality of life of young adult cancer survivors by addressing potential late effects as well as medical and psychosocial issues through multidisciplinary care. We plan to increase the young adults’ knowledge of their cancer treatment, teach skills to maintain good health, help navigate them to manage any late effects from their treatment, and assist them with finding resources for any medical or psychosocial needs. Objectives: To improve patient outcomes by providing a clinical nurse navigator who would offer the patient a summary of cancer treatment and survivor care plan, help the patient find and establish care with a primary care physician, offer a survivor clinic with a focus on young adult survivors, and implement a wellness activity of exercise or nutrition improvement. Methods: Patient outcomes were measured by using a database (E Centaurus) to track the metrics in the objectives outlined above and to perform a comparison study of the patient usage of the emergency department services or hospitalization in the year prior to survivorship navigation. The nurse navigator had a target goal of completing a summary of cancer treatment and a survivor care plan within 3 months of enrolling a patient. The navigator also assisted the patient to coordinate care with a primary care provider who was also given a copy of the survivor’s care plan and summary. The nurse navigator meets the patient in the survivor clinic where each patient is seen by an internal medicine physician who specializes in caring for cancer survivors and is well versed in potential late effects and surveillance for young adult survivors. The physician and nurse enable the patient to plan for increasing patient physical activity or nutrition goals by offering information for various programs available to young adult survivors of cancer. Results: Preliminary analysis showed that after 1 year of navigation for 74 patients, a direct cost-savings of $90,000 was achieved. Currently our efforts show that 97% of patients established care with a primary care physician within 3 months of navigation. Approximately 93% of patients navigated are given a treatment summary and care plan within 3 months of enrollment. Some wellness activity was initiated by 67% of patients within 12 months of enrollment, and 62% have reached the goal of a wellness activity. Patient satisfaction with the survivor clinic was rated as 96%, equaling “very good” or excellence overall. Conclusions: These efforts clearly demonstrate the effectiveness in improvement of health outcomes for an “at risk” population of young adult cancer survivors. It also demonstrates a reduction in the cost utilization for the emergency department and hospitalization services.
STAR Program Certification Course Improves Nurses’ Knowledge of Evidence-Based Cancer Rehabilitation and Survivorship Care
Jeanne Simard, RN, MBA; Julie Silver, MD
Oncology Rehab Partners
Objective: The objective of this study is to present pretest and posttest scores of nurses who have completed the STAR Program® Certification Course and to demonstrate the improvement in overall knowledge and expertise of cancer and cancer rehabilitation that the course provides. The STAR Program Certification includes training modules and protocols based on the latest research in cancer rehabilitation and survivorship care. As part of the precertification process, participants take the STAR Program Certification Course, which is an online course with 10 modules and a pre- and posttest. The entire course generally takes participants between 20 and 30 hours to complete. Methods: In this study, an identical 50-question pretest and posttest was administered. There was no time limit to finish the modules. The tests were administered to all candidates. They could take the test as many times as necessary to obtain a passing score of 70%. The raw test scores were averaged and grouped according to participant discipline. A total of 2238 pretest scores were obtained from 2226 candidates who listed 39 healthcare disciplines (includes duplicates from the pretest total participant group). Duplicates were removed from the nursing pre- and posttest data to give a true picture of the results. Fifty candidates did not record their discipline. Results: The average pretest score of all candidates was 46.3%. The category including “All Nurses” (registered nurse, nurse navigator, and nurse practitioner) numbered 456 for the pretest group and had an average score of 45.1%. This research only includes nurses who completed both the pretest and posttest. This pretest group numbered 269 and had an average score of 44.5% (Table). A total of 1391 participants comprised the total posttest group and took the test 1582 times. The postscore for “All Nurses” was 92.8% (N=269). The average postscore for all candidates (all disciplines) was 88.8% with a range of 0% to 100%. The test was taken once by 1287 candidates and multiple times by 104. Conclusions: The STAR Program Certification Course significantly increased nurses’ and other participants’ knowledge in evidence-based cancer rehabilitation and survivorship care. The average improvement between pretest and posttest scores was 108% for the “All Nurses” group. This study demonstrated significant improvement in nurses’ knowledge of cancer rehabilitation and survivorship after completing the STAR Program Certification Course.
Breast Cancer Nurse Navigator Facilitating Care Transitions in Cancer Survivorship
Danelle Johnston, RN, MSN, OCN, CBCN
St Jude Medical Center
Background: The Institute of Medicine has identified that cancer survivors lack coordinated care beginning at the time of their diagnosis and throughout the cancer care trajectory. The cancer survivor’s quality of life (QOL) and health outcomes are therefore impacted. The research question addressed in this study was: How is the breast cancer nurse navigator positioned to facilitate transitions along the breast cancer survivorship continuum that impact QOL in the domains of prevention, surveillance, intervention, and coordination? Objective: To gather data on the current state of the breast cancer nurse navigator’s role, attitudes/beliefs, and knowledge in facilitating care transitions for breast cancer survivors. Methods: An electronic descriptive survey instrument was developed based on the domains of survivorship. The survey was designed to evaluate how the breast cancer nurse navigator is currently positioned to facilitate a patient’s transitions through the cancer survivorship care continuum. The questionnaire allowed qualitative and quantitative data collection. The content validity of this 45-item scale was rated by 3 breast cancer nurse navigator experts. The scale level index (S-CVI), using the averaging approach, was calculated to be 0.94. A convenience sample of breast cancer nurse navigators was surveyed through the Academy of Oncology Nurse & Patient Navigators, which gave nationwide access to breast cancer nurse navigators (N= 986). The survey was entered into SurveyMonkeyTM to allow online delivery, and data were stored and analyzed using IBM SPSS Statistics 21 for Windows. Results: There was a 20% response rate (n=200) for breast cancer nurse navigators who participated in the survey. The rate for participants who completed the survey in its entirety was 12% (N=115). Participant fallout in survey completion was attributed to the length of the 77-item survey. The study provided evidence that the breast cancer nurse navigator had strong attitudes/beliefs that they can be positioned to facilitate survivorship care transitions, to eliminate barriers to care, and to impact survivors’ QOL. A low score (48%) for cancer survivorship knowledge validated a knowledge deficit among the navigators. There was variation in the role of the breast cancer nurse navigator in care transitions for the cancer survivor. Conclusions: The data obtained from this study support the hypothesis that there is a wide variation in role, attitudes/beliefs, and knowledge of the breast cancer nurse navigator in the cancer survivorship care continuum. This study identified that nurses place strong value in facilitating cancer survivorship care. Navigators intersect with the cancer survivor throughout the cancer care continuum, which places them in a prime position to facilitate survivorship care.
What Young Women Want: A National Needs Assessment of Young Women Affected by Breast Cancer
Arin Ahlum Hanson, MPH, CHES1; Janine E. Guglielmino, MA1; Kimlin Ashing-Giwa, PhD2
1Living Beyond Breast Cancer; 2 City of Hope Medical Center
Background: Ten percent of breast cancer cases occur in women who are younger than 45 years of age. Although younger women are less likely to be diagnosed, their treatment experience and psychosocial needs can differ, making it a significant public health concern for women diagnosed in this age group. There are limited national programs and resources that address the unique needs of young women. Living Beyond Breast Cancer conducted a comprehensive national needs assessment to identify the needs of women diagnosed with breast cancer before 45 years of age and to determine how young women prefer to receive emotional support and breast cancer information.
- To identify the needs of women diagnosed with breast cancer who are younger than 45 years of age;
- To assess the information and support needs of young women affected by breast cancer;
- To evaluate subgroup differences regarding ethnicity, stage of breast cancer, time since diagnosis, and age at diagnosis;
- To identify existing gaps in program areas for young women.
Methods: The needs assessment included 4 phases: (1) an environmental scan was conducted to identify existing resources for young women; (2) key informant interviews were conducted with 12 healthcare providers; (3) 4 focus groups were held with 32 women; and (4) a national survey was drafted using information collected from the interviews and focus groups. This 85-question survey was completed by 1474 women diagnosed with breast cancer who were younger than 45 years of age. The survey asked women where they go for emotional support and cancer information, how they want to receive support and information, and what information topics interest them and are available. Demographic and breast cancer treatment information was collected. Results: Living Beyond Breast Cancer engaged a diverse sample of young women from across the United States. It was concluded that there are limited national resources for young women. Ninety percent of the survey respondents said it was important to have health information about breast cancer tailored to their needs as young women; however, only 22% found it easy to find this type of information. Certain subgroups of young women reported having a more difficult time finding information and support, including women diagnosed before 30 years of age, African Americans, and women living with metastatic breast cancer. Many young women report lingering side effects—50% reported fatigue, sleep disruption, decreased interest in sex, and weight changes. Conclusions: More programs and resources should be developed to address the unique needs of young women affected by breast cancer. The needs and program gaps identified through these assessment results will help guide program development.
Interdisciplinary Team Education to Improve the Care of the Cancer Survivor
Danelle Johnston, RN, MSN, OCN, CBCN; Gianna Laiola, RN, MSN, OCN
St Jude Medical Center
Background: Due to improvements in technology, treatment, and screening, the National Cancer Institute (NCI) estimates that the number of patients with cancer could reach 18 million by 2020. The Institute of Medicine (IOM) reports that survivorship care is fragmented and the literature documents that healthcare providers frequently demonstrate a knowledge deficit in survivorship care needs. Based on this need, St. Jude Medical Center oncology professionals attended an NCI-funded conference entitled “Preparing Professional Nurses for Cancer Survivorship Care.” Conference participants developed goals to be implemented at their institution, which were foundational for this study. Objectives: To assess the current interprofessional staff level of survivorship care knowledge and to evaluate the effectiveness of an education program in improving survivorship care knowledge. Methods: A review of the literature identified the needs of cancer survivorship, and topics were selected for an interprofessional education series. Individual course objectives were based on the IOM’s report “From Cancer Patient to Cancer Survivor.” Speakers were selected based on content expertise in cancer survivorship care. Coordination with the Clinical Education Department facilitated the provision of continuing education units, and participants included members of the interdisciplinary team. Online registration and WebEx were offered for each presentation. Marketing strategies included flyers and advertising. Pre- and posttest scores for each session were compared and contrasted across content sessions. Results: To date, 7 months of presentations have been offered and completed. The total number of participant attendance was 76 with a retention rate of 41% for those attending 3 or more sessions. Posttest scores (M = 88.68; standard deviation [SD] = 10.47) showed a 19% knowledge increase from pretest scores (M = 69.37; SD = 21.60). The posttest and increase in test scores were significantly correlated (P = .01); the interaction effect among posttest sessions was significant (F[6,66] = 4.13; P = .001). The majority of participant oncology work time (57%) was spent addressing survivorship needs. Conclusions: Barriers to attendance included scheduling, unpaid time, and knowledge deficit of survivorship care. For those who attended classes, retention was high. Nurse navigators and rehabilitation staff participated most frequently. Rehabilitation staff were recently certified in Survivorship Training and Rehabilitation, and they reported that the presentations continued to build on their cancer survivorship knowledge. Participants found value in the series, as evidenced by knowledge gained and satisfaction with the educational offering. Although attendees were experienced practitioners with longevity in their fields, survivorship care was identified as a significant educational need by participants.
Nursing Implications of a New Oral Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765), for Use in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Patients (Pts)
Weihong Chase, MSN1; Sharon Waymer, LPN1; Mona Stefanos, MD1; Margaret Lucas, BS1; John Byrd, MD1;
Talia LaPushin, MPH1; Danelle James, MD, MS2; Betty Chang, PhD2; Cathy Zhou, MS2; Juthamas Sukbuntherng, PhD2; Susan King, MS2; Joanne Vanak, MSN3; Jeanne Lichty, BSN4
1Ohio State University Medical Center; 2Pharmacyclics, Inc.; 3Janssen Biotech, Inc.; 4MD Anderson Cancer Center
Background: Ibrutinib, a first-in-class, orally administered Bruton’s tyrosine kinase inhibitor, has demonstrated single-agent activity in relapsed/refractory chronic lymphocytic leukemia (R/R CLL) small lymphocytic lymphoma (SLL) in early clinical trials. Ibrutinib first entered clinical trials in 2009, and based on results of early trials, ibrutinib was granted Breakthrough Therapy Designation for mantle cell lymphoma and 17p deletion CLL by the US Food and Drug Administration in February 2013; the new drug application was filed in the second quarter of 2013.
Objectives: The phase 1b/2, open-label multicenter study evaluated the safety, efficacy, pharmacokinetics, and pharmacodynamics of ibrutinib. As with all new treatments, ibrutinib has the potential to produce adverse events (AEs), which have implications for patient monitoring. Moreover, the drug’s novel mechanism of action (MOA) will also require education of nurses, who will often be responsible for educating patients.
Methods: In PCYC-1102, 85 R/R CLL/SLL patients received either ibrutinib 420 mg/day (n=51) or 840 mg/day (n=34) orally, once daily continuously until disease progression or unacceptable toxicity was noted.
- Patients were generally considered to have high-risk disease, having received a median of 4 prior therapies.
- At a median follow-up of 20.9 months (range, 0.7-26.7), 64% of patients were still receiving treatment.
- Most AEs were grade 1/2 in severity; the most common were transient diarrhea, fatigue, and respiratory infection.
- The most common grade ?3 AEs were pneumonia (10 patients; 12%) and dehydration (5 patients; 6%).
- Grade ?3 infections occurred more frequently early in therapy; grade 3/4 hematologic toxicities were infrequent, with anemia in 5 patients (6%), neutropenia in 13 (15%), and thrombocytopenia in 5 (6%); grade ?3 bleeding events occurred in 4 patients (5%).
- Lymphocytosis was typically noted by day 7; peaked at a median of 4 weeks, then slowly declined; this occurred concomitantly with reductions in lymph node and/or spleen size and often with improvement in cytopenias. Most patients normalized or achieved a 50% reduction from baseline in their lymphocyte count.
- The overall response rate was 71%; the 26-month estimated median progression-free survival and overall survival rates were 75% and 83%, respectively.
- Ibrutinib is a highly active new agent showing single-agent activity in R/R CLL.
- Nursing implications include education about: (1) new MOA, (2) rapid reduction in lymph nodes without tumor lysis syndrome, (3) lymphocytosis, (4) the importance of reporting signs and symptoms of infection and/or bleeding, (5) adherence to oral dosing, (6) drug–drug interactions with CYP3A4/5 inhibitors, (7) avoiding warfarin or equivalent vitamin K antagonists, and (8) consulting their oncologist if surgery or an invasive procedure is required.
- Nursing advisory board recommendations will be shared with nurse navigators who will invariably be asked to help patients navigate through the authorization/approval process for this new oral oncolytic and to identify sources for patient copay and other financial assistance.
Patient Navigation: Blending Imaging and Oncology in Breast Cancer
Jeannine Arias, RN MSN, MBA, AOCNS, CBCN
Adventist Midwest Health System
Background: Patient navigation (PN) in cancer care refers to the individualized care provided to patients with breast cancer, their families, and caregivers to ease multiple barriers and facilitate timely access to qualified medical and psychosocial care. The relatively new PN concept has become a healthcare buzzword as organizations strive to increase program efficiencies and system retention rates. Objective: To evaluate the optimization of our regionalized imaging/oncology PN service program. Specifically, the evaluation process examines imaging/oncology volumes, retention rates, and integration rates of our service lines after 2 years of phased PN implementation. Methods: Our review and evaluation were performed through the following initiatives: (1) Identify key stakeholders, patient groups, and current resources. (2) Define the scope of the PN involvement, job description, necessary educational preparation, and expectations. (3) Identify the current PN process. (4) Identify gaps, obstacles, and barriers to patients and families. (5) Determine program scope, cost, and implementation strategy. (6) Perform a needs assessment. (7) Develop a plan to bridge weaknesses in the current process. (8) Develop a plan to address the weaknesses. (9) Implement strategies. (10) Develop program outcome measures based on identified gaps and national quality-of-care standards. (11) Evaluate for future goals. Results: Immediate onset of PN services, timely treatment, and follow-up remain pivotal in patient satisfaction, outcome measures, retained volumes, quality improvements, and cost-effectiveness. Our recall rate, positive predictive value, false predictive value, and cancer detection rate are well controlled and mirror or better benchmark data. Our imaging volumes have increased 22% and our surgical/oncology volumes have increased 355%. Two of our 3 centers have earned the national accreditation programs for breast centers. The PN employees have been nationally certified in PN. Conclusions: Performing a systematic evaluation is vital in the identification of the program’s strengths and weaknesses. Regionally, our combined efforts have strengthened our cohesiveness and raised the bar with a friendly competitive spirit.
Patient Navigation Role Delineation
Anne Willis, MA; Elisabeth Reed, MPA; Heather Kapp, MSW, LICSW; Elizabeth Hatcher, RN, BSN; Mandi Pratt-Chapman, MA
George Washington University
Background: Community health workers (CHWs), patient navigators (also sometimes called lay navigators), and nurse and social work navigators all play critical roles in removing barriers to care and addressing health disparities. CHWs are embedded in the community, nurse and social work navigators are embedded in the healthcare institution, and patient navigators often serve to bridge the community and the healthcare system. With the rapid growth in the number of navigation programs and lack of consensus on terms and definitions, a need exists to clarify terms, roles and responsibilities, and differences across these 3 navigator types. Much progress has been made in defining competencies, roles, and responsibilities for CHWs and nurse and social work navigators, while less has been done for patient navigators. Objective: To fill the gap in the identification of competencies, roles, and responsibilities of patient navigators, this project sought to describe common functions across the 3 navigator types and delineate the distinct role each plays in the community and healthcare system. Methods: We used a 3-step method to delineate the navigation roles. First, we searched the literature, web-based documentation of established competencies, and publicly accessible training curricula to gather already-defined competencies, roles, activities, and/or tasks across the 3 navigator types. Then we created a Framework for Navigation, where we identified competency domains from the search (eg, cultural competency, care coordination, removing barriers to care) and mapped the competencies, roles, activities, and/or tasks to each domain for each navigator type. Finally, we brought together a group of chws, patient navigators, nurses, and social workers to define each competency domain to highlight the similarities across the 3 navigator types and to identify the key differences in roles for each navigator type. Results: The project resulted in a draft Framework for Navigation that specifies the commonalities and differences between CHWs, patient navigators, and nurse and social work navigators. Conclusions: This project is an important step toward standardizing the scope of work of patient navigators. The next steps will be to gather consensus on the differences across navigator types, clarifying patient navigation roles and responsibilities, and developing competencies for patient navigators.
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