If you are a female in the United States, your lifetime risk of being diagnosed with breast cancer is 1 in 8.1 If you are a male, the risk is [ Read More ]
Best Practices in Breast Cancer – October 2016 Vol 7
AONN+ Announces the Breast Cancer Research Abstracts to be Presented at the Annual Meeting
The Academy of Oncology Nurse & Patient Navigators (AONN+) is holding its annual meeting November 17-20, 2016, in Las Vegas, NV. In this special breast cancer issue of JONS, we are proud to present the 12 evidence-based breast cancer research abstracts that will be presented as posters at the conference. These abstracts and posters represent the best in evidence-based breast cancer navigation research.
It is our hope the research presented will inform, inspire, and impact your ability to offer more efficient navigation programs at your institution.
A Novel Approach for 2-Stage Breast Reconstruction: Patient-Controlled Tissue Expansion Using the AeroForm CO2 Tissue Expander System
Jenny Saldaña, BA, Patient Navigator and Breast Cancer Survivor
Columbia Presbyterian Medical Center
Objectives: The tissue expansion process using standard of care, saline-filled expanders is lengthy, inconvenient, and uncomfortable and may lead women to make the decision to decline breast reconstruction. The efficacy and safety of a novel, needle-free, patient-controlled tissue expander using CO2 as the filling medium was compared with the standard of care in the US-based XPAND study. Data from this multicenter, prospective, randomized clinical trial are presented to inform care providers of this new development in breast reconstruction.
Methods: One hundred fifty women were enrolled and randomized (2:1) to the AeroForm expander or traditional saline expander control group. Inclusion was restricted by age (18-65 years), BMI (<33), and tissue suitability for expansion. Women randomized to the AeroForm group self-administered 10-cc doses of CO2 up to 3 times daily, whereas the saline group underwent serial injections of saline. Upon reaching full expansion, the expanders in both groups were exchanged to standard breast implants. This paper presents data for the latest generation of the device from 72 patients: 44 CO2 and 28 saline implanted within the same time period. The protocol was designed as a noninferiority study, and the protocol-stated success for the primary end point (successful second-stage surgery) was a margin of ≤10%. Additional end points analyzed include successful second-stage surgery, time to complete expansion, time to reconstruction, and satisfaction.
Results: Data are presented by breasts implanted with an expander (AeroForm = 78, saline = 50), with the successful exchange to breast implant achieved in 97.3% (CO2) and 97.8% (saline) of patients. The primary end point was met with the treatment difference (–0.51) within a margin of noninferiority of –7.7. The average number of expansion days were 17 for CO2 and 35 for saline, and total reconstruction days were 111 for CO2 and 121 for saline. Overall satisfaction for the AeroForm was 84% (patients) and 89% (physicians).
Conclusions: The results of the XPAND study demonstrate that patient-controlled, needle-free CO2 expansion using the AeroForm expander is a viable alternative to saline expansion for 2-stage breast reconstruction. Management of patients receiving this device will be critical to successful adoption of the technology when it becomes available for general use in the United States.
AltaMed Health Services: Breast Cancer Outreach and Screening Program
Marlene Luna, MPH; Arlene Bruins, MS
AltaMed Health Services
Objective: Women living in Los Angeles and Orange County have low mammography screening history; only 65.6% of women have had a mammogram in the past 2 years or less.1 Research has demonstrated that the primary reason women do not receive mammograms is the expense or lack of insurance.2 Through a grant provided by the American Cancer Society, AltaMed Health Services (AltaMed) implemented a Breast Cancer Outreach and Screening Program with multiple elements. The overall program aims to provide breast health education and screening mammograms to eligible women who are patients at the West Covina, El Monte, and Santa Ana-Bristol clinics.
Methods: The program was multifaceted and included postcard mailings, patient incentives to attend their mammogram appointments, clinic staff training, clinic staff incentives, and a health education intervention led by a health promoter. Studies have proved that health promoter–based interventions increase breast health education and likelihood of mammography screening.3-9 In order to improve communication, education, and ultimately participation for eligible women aged 50 to 74 years, health promoters at 3 clinics (West Covina, Santa Ana-Bristol, and El Monte) were assigned to make patient phone calls to women who received a postcard but did not come in for their screening. The health promoter provides language assistance and culturally sensitive education, answers questions or concerns the women may have about mammography screening, and ultimately encourages women to schedule a mammogram screening at no cost. If women have any transportation obstacles, they are offered a gas card or taxi voucher. During on-site mammogram days at the clinic, health promoters provide breast health education and promote preventive behaviors to women receiving mammograms.
Results: In year 1 of the project, AltaMed was able to increase its screening rate from 46% to 69% at the participating clinics. In year 2 of the project, which is still in progress, AltaMed has surpassed its goal of screening 1367 women at the 3 clinics by screening 1460 women as of July. It has already achieved a collective screening rate at the 3 clinics of 67%, which represents a 21% increase over the baseline.
Conclusion: The use of culturally and linguistically appropriate health education led by a health promoter is one aspect of a multipronged approach to addressing low breast cancer screening rates among uninsured and underserved Latinas. The systems and processes developed through this grant to increase breast cancer screenings at the 3 participating clinics are replicable and will be spread to additional AltaMed clinics with low breast cancer screening rates.
- UCLA Center for Health Policy Research. AskCHIS 2019. Main reason for not having mammogram. http://ask.chis.ucla.edu. Accessed July 15, 2016.
- UCLA Center for Health Policy Research. AskCHIS 2012. Mammogram screening history. http://ask.chis.ucla.edu. Accessed July 15, 2016.
- Hansen LK, Feigl P, Modiano MR, et al. An educational program to increase cervical and breast cancer screening in Hispanic women: a Southwest Oncology Group study. Cancer Nurs. 2005;28:47-53.
- Hiatt RA, Pasick RJ, Stewart S, et al. Community-based cancer screening for underserved women: design and baseline findings from the Breast and Cervical Cancer Intervention Study. Prev Med. 2001;33:190-203.
- Larkey L. Las mujeres saludables: reaching Latinas for breast, cervical and colorectal cancer prevention and screening. J Community Health. 2006;31:69-77.
- Livaudais JC, Coronado GD, Espinoza N, et al. Educating Hispanic women about breast cancer prevention: evaluation of a home-based promotora-led intervention. J Womens Health (Larchmt). 2010;19:2049-2056.
- Molina Y, Thompson B, Espinoza N, et al. Breast cancer interventions serving US-based Latinas: current approaches and directions. Womens Health (Lond). 2013;9:335-348.
- Sauaia A, Min SJ, Lack D, et al. Church-based breast cancer screening education: impact of two approaches on Latinas enrolled in public and private health insurance plans. Prev Chronic Dis. 2007;4:A99.
- Valdez A, Banerjee K, Ackerson L, et al. A multimedia breast cancer education intervention for low-income Latinas. J Community Health. 2002;27:33-51.
Developing the First Global Breast Cancer Education Campaign: Findings on Patient Knowledge and Effective Communication Design
Corrine Ellsworth Beaumont, PhD
Background: Each year, breast cancer kills more than 500,000 women worldwide (World Health Organization [WHO], 2016). In resource-poor settings, most are diagnosed at an advanced stage, with survival rates ranging from 10% to 40% (WHO, 2016). This contrasts sharply with settings in which early detection and basic treatment are available and accessible, with survival rates for early-stage breast cancer above 80% (WHO, 2016). This research investigates a method for improving these outcomes in both settings by sharing the success of the first global breast cancer awareness campaign and educational materials to help patients identify symptoms earlier. We ask, “How can nurse navigators better educate disparate populations about breast health and cancer screening at home and abroad?”
Objectives: 1) Help a diverse global and local population understand the symptoms of breast cancer through the use of a familiar metaphor, 2) overcome literacy issues by teaching through visuals rather than text descriptions, and 3) use friendly imagery to engage audiences and avoid censorship issues associated with breasts.
Methods: A patient-centered “U.S.E.R. Design Thinking Framework” (Beaumont, 2011), which was a mixed method of action research, iterative prototyping, interviews, and co-creative methods to identify problems and develop solutions within the health system, was used to develop the materials for a multilingual audience. User testing and patient surveys identified communication accuracy as the visuals were tested prior to deployment.
Results: Survey (n = 255) revealed that 51% of patients didn’t know what a cancerous lump felt like. Communication barriers were connected to negative emotions such as fear of cancer, disinterest, taboos associated with displaying breasts, and low literacy. Knowing this, a visual metaphor was developed as a stand-in for the breast (a friendly lemon) to avoid fear, taboo, and communicate without an overdependence on text while more effectively engaging the public. The educational materials illustrated cancer symptoms, information about palpability, and breast anatomy in relation to breast self-exam and the diagnostic pathway. Patient testing (n = 36) with the materials showed the visuals increased accurate tactile knowledge for breast self-exam (86%) compared with a traditional illustration (15%), and reported patient confidence in recognizing signs of breast cancer was high (89%). Further testing (n = 67) revealed that people could accurately identify most of the visual symptoms without a text label, making it a valuable teaching tool for low-literacy audiences.
Conclusions: Results show that visual metaphors likely have a strong impact on informing the public about breast cancer symptoms more effectively than traditional text-based methods. A more accurate tactile knowledge and understanding of visual signs of breast cancer could lead to decreased mortality rates by improving early reporting of symptoms in the United States and worldwide. Nurse navigators could use these materials to educate patients and promote breast cancer awareness in their local communities to reach disparate populations more effectively without having to use multiple sets of materials to reach multiple audiences.
Note: This was presented as an electronic poster at ONS 2016.
Eight Case Studies of Concurrent Pathogenic Mutations Identified in Hereditary Breast and Ovarian Cancer Gene Panel
Lilian Servais, MS, LCGC; Lauren Ryan, MS, LCGC; Jeroen Van den Akker, PhD; Annette Leon, PhD, MS, FACMG
Objectives: The availability of next-generation sequencing (NGS) and characterization of multiple genes that can increase cancer risk have caused a shift toward multigene panel testing for hereditary cancer. However, the occurrence of concurrent pathogenic mutations and the utility of panels in individuals who have a known mutation in the family is yet to be well evaluated. We reviewed the personal and family histories of patients found to have multiple pathogenic or likely pathogenic mutations when tested clinically for 19 genes for hereditary breast and ovarian cancer and the implications for the patient and his or her family.
Methods: Samples were analyzed with a 19-gene panel that included NGS of ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, EPCAM, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, PTEN, RAD51C, RAD51D, STK11, and TP53. All mutations were classified according to current American College of Medical Genetics and Genomics guidelines.
Results: Seven patients with 2 concurrent mutations and 1 patient with 3 concurrent mutations were identified in the testing of patients with a 19-gene panel for hereditary breast and ovarian cancer. Mutation combinations included: BRCA1 + CHEK2 (3), ATM + BRCA1 (1), ATM + CHEK2 (1), ATM + BRCA2 (1), BRCA1 + PMS2 (1), and BRCA1 + BRIP1 + CHEK2 (1). Four of the 8 patients (50%) underwent panel testing in the setting of 1 known family mutation. Three patients (38%) were the first person in the family to undergo genetic testing. One patient underwent previous genetic testing with a large cancer panel that identified both pathogenic mutations. Two patients (25%) had a personal history of cancer, and 6 of 8 (75%) had no personal history of cancer. Seven of 8 (88%) patients met National Comprehensive Cancer Network criteria for genetic testing for hereditary breast and ovarian cancer based on personal and/or family history.
Conclusions: Identifying patients with multiple clinically actionable mutations may have important medical implications for the patients as well as for family members. These data suggest those at risk for a known family mutation may still be appropriate candidates for multigene panels due to the risk of multiple mutations. Further research on a larger data set is needed to better elucidate this finding.
Identifying Gaps in Metastatic Breast Cancer Patient Knowledge and Their Communication Experiences with Healthcare Professionals
Corrine Ellsworth Beaumont, PhD1; Katherine Crawford-Gray, MBA, MSc2
1WorldwideBreastCancer.com; 2Metastatic Breast Cancer Alliance
Objectives: When patients are told they have metastatic breast cancer (MBC), it’s very difficult for them to absorb and interpret what is being told to them at the time of their terminal diagnosis. We ask, “How can nurse navigators more effectively communicate with MBC patients with these challenges in mind?” To help with this objective, we first need to clarify the current state of communication between healthcare professionals (HCPs) and MBC patients to identify areas for communication improvement and improved patient knowledge about their disease.1,2 This can then inform development of tools to aid in communicating with MBC patients during initial diagnosis and treatment planning discussions.
Methods: An online population survey of MBC patients (n = 563) measured patient communication experiences reflecting on what conversations with HCPs were like prior to starting treatments for MBC. Survey recruited from November 2015 to June 2016 through MBC patient organizations. Segmenting factors were education level, age, racial background, marital status, and time since diagnosis of MBC.
Results: More than half of respondents (56%) were diagnosed with MBC in the past 2 years. Majority of respondents were white (90%), supported (72% married and 95% insured), highly educated (30% with postgraduate degree), with a larger group de novo, stage IV from beginning (37%) compared with the general MBC population in the United States that has a recurrent diagnosis that progressed to metastatic disease (~10%-20%).
Whereas 96% of patients surveyed indicated they knew their cancer type, less than half (46%) included both HER2 and hormone status when asked to describe their type. One-third of patients felt they didn’t have enough knowledge to participate in decision-making around their treatment options; 58% of patients felt rushed and starting treatment was urgent; less than one-quarter (24%) sought a second opinion; 38% did not research treatment options prior to starting therapy; 71% did not recall discussing goals/hobbies as part of their pretreatment talks; 69% said complementary therapy was not discussed by their oncologist; only 22% said treatment breaks were mentioned; and just 62% discussed pain and symptom management. Nearly two-thirds did not discuss clinical trials as part of their treatment plan. Patients did not recall quality-of-life considerations during initial treatment discussions after a metastatic diagnosis.
Conclusions: Communication gaps between HCPs and MBC patients must be addressed to improve the patient experience. Patients likely overestimate their knowledge about their breast cancer subtype. Not realizing they know less than they should, they also likely overestimate their ability to participate in decision-making about their treatment. To improve patient engagement in discussions, and their confidence level in decision-making, more needs to be done to educate patients on their cancer subtype, second opinions, and participating in clinical trials. Treatments that improve quality of life, such as palliative care, complementary therapy, and treatment breaks, need to be better integrated in treatment discussions. Discussion and education tools could greatly impact the success of these difficult conversations.
- Mayer M, Huñis A, Oratz R, et al. Living with metastatic breast cancer: a global patient survey. Commun Oncol. 2010;7:406-412.
- Freedman RA, Kouri EM, West DW, et al. Racial/ethnic disparities in knowledge about one’s breast cancer characteristics. Cancer. 2015;121:724-732.
Implementing a Survivorship Program in a Community Hospital–Based Cancer Center to Meet Standard 2.20 for NAPBC Accreditation
Cheryl Syta, RN, MS, AOCNP; Barbara R. McHale, RN, BS, OCN, CBCN; Jessica Sawicki, RN; Jacqueline Dorn, MSW Intern
St. Mary’s Cancer Treatment Center, SPHP, Troy, New York
Background: The impetus to create a survivorship program at our community hospital–based cancer center was our desire to attain NAPBC accreditation. NAPBC Standard 2.20: a comprehensive breast cancer survivorship care process, including a survivorship care plan (SCP) with accompanying treatment summary, is in place within 6 months of completing active treatment and no longer than 1 year from date of diagnosis. The IOM in 2005 recommended a treatment summary and follow-up care plan be given to every cancer patient, and it should be clearly explained. Survivors typically do not remember important details of their diagnosis, treatment, and long-term effects. They are searching for meaning in their lives and struggle with a sense of control following the life-altering experience of cancer.
Objectives: To develop a survivorship program that meets the NAPBC accreditation standard; delivers evidence-based, patient-centered care, and is financially sustainable.
Methods: 1) Work group was established in late 2014. We evaluated many software programs for developing a survivorship care plan. We needed one that would interface with our cancer registry, Metriq. Journey Forward was chosen as it communicates with Metriq. 2) All eligible breast cancer patients stage 0 to III were deemed eligible. 3) Our rationale for a nurse practitioner (NP)-driven program has been supported by return on investment (ROI); program billable at a level 5 based on face-to-face time spent with patient. NP scope of practice includes ordering further workup (labs, imaging) and initiating referrals to address patients’ current needs and issues. 4) NCCN distress tool is given on first follow-up visit (after active treatment ended) to reassess needs/issues. NP and navigator developed a survivorship pathway map to standardize the process. 5) Implementation was to start in 2015 and review process quarterly. 6) Social worker identified financial, social, communication, and logistical barriers and added resources/referral sites for our SCP. 7) Tracked NP, navigator, and oncology nurse time spent completing SCP. Validated that this is billable for a level 5 by NP, which will assist in making program sustainable.
Results: 1) NP tracked all eligible breast patients for 2015. A total of 54 patients were considered eligible: 17 (31.5%) SCPs were completed, 8 (14.8%) were HER2+ and are still under treatment, 9 (17%) were late, and 20 (37%) were still to be completed within the 1-year time frame. 2) The number of distress tools completed of all eligible patients with SCPs in place was 13 of 17 (76%). 3) Overall cost of SCP development was $148. Mean for insurance reimbursement ~$431. ROI: ~$283 for SCP and treatment summary.
Conclusions: An NP-driven survivorship program was developed and has proved to be financially sustainable. The original pathway process for scheduling patients for an SCP visit after active treatment was modified due to documented issues with process. With input from staff, a new standard work order process was implemented. Review of program and data provided us with the realization there needed to be NP time blocked out for a 1-hour prep for each SCP and 1 hour for a survivorship visit. Currently we do not have a method to monitor effectiveness of a survivorship visit. We have been assessing tools to measure effectiveness, ie, patient education/knowledge and patient satisfaction. This will add to the body of data needed to promote future programs of this nature.
Navigator Identification of Breast Biopsy Results: A Time Analysis of Biopsy Results and Variance in Turnaround Time
Laurie A. Dressman, RN, BA
Sarah Cannon Cancer Institute, Kansas City
Objective: To improve the turnaround time of breast cancer biopsy pathology to maximize patient care. This includes:
- Interval between date biopsy performed and initial result showing type of breast cancer
- Interval between date biopsy performed and biomarker results
- Interval between date biopsy performed and fluorescence in situ hybridization (FISH) test
Methods: The study was conducted by the nurse navigator at Sarah Cannon Cancer Institute at Research Medical Center in Kansas City, a member of the oncology service-line for HCA. Nurse navigators are exposed to many processes in the cancer care system and recognize when systems are not at optimal functioning. In this study, 25 female patients who had biopsies derived from US-guided, stereotactic, and MRI-guided methods were randomly chosen over a 6-month time frame. All biopsies were performed by an interventional radiologist. Of the 25 patients, 23 had biomarkers, and 7 were required to have FISH testing. These patients included all race, religion, and age groups.
Results: The average interval for the initial biopsy results was 1.88 days, with the longest interval being 5 days and the shortest 1 day.
The average interval between the initial biopsy result and the biomarker result was 6.21 days, with the longest interval being 11 days and the shortest 2 days. The average interval between the initial biopsy result and FISH results were 11.14 days, with the longest interval being 14 days and the shortest 7 days.
Conclusions: The division has a monthly Pathology Steering Committee meeting between our pathology lab and our lab director and/or Sarah Cannon physicians. Our director brought these results to the meeting along with 2 of our breast specialist physicians to establish turnaround expectations and identify barriers in the current process. Numerous factors inherent to analyzing pathology specimens (eg, weekends, holidays, number of slides, consultations with other pathologists, etc) can factor into timely reporting.1 Several internal processes at this pathology lab that caused undue delay were examined, as well as identifying lack of “reflex” biomarker and FISH testing for positive breast biopsy specimens. Modifications were adopted, and continued monitoring of delays with additional adjustments implemented.
Maximizing turnaround time on biopsy results ultimately lead to better and faster patient care. Navigators are frontline touchpoints to identify deficiencies in the system.
- Patel S, Smith JB, Kurbatova E, et al. Factors that impact turnaround time of surgical pathology specimens in an academic institution. Hum Pathol. 2012;43:1501-1505.
Overcoming Barriers to Lymphedema Education and Treatment for Breast Cancer Patients in Rural Eastern North Carolina
Debra C. Mascarenhas, RN, BSN, BSBA, CBCN; Allyson H. Daugherty, PT, CLT, CFm; Judy Koutlas, RN, MS, OCN
Vidant Medical Center:
Background: Approximately 42% of breast cancer survivors develop clinically detectable lymphedema within 5 years of treatment. Lymphedema risk factors include axillary node surgery, radiation therapy, infection, tumor growth, and obesity. Early intervention and education is crucial to decrease long-term morbidity and improve patient outcomes.1
Prior to the implementation of the breast navigation program, our institution lacked a standardized patient education and referral process for lymphedema therapy. Patients in rural eastern North Carolina frequently have limited insurance coverage for lymphedema therapy and garments. Our county also lacks certified lymphedema therapists (CLTs) who accept Medicaid.
Objectives: 1) Increase early detection of lymphedema by providing education on risk factors, signs/symptoms, and preventive measures of lymphedema; 2) Identify and refer high-risk and symptomatic patients to CLTs for treatment; 3). Assess patients for financial barriers; and 4) Provide financial assistance to patients identified as having financial barriers to lymphedema care.
Methods: The breast cancer navigator (BCN) sought grant funding to implement an education program for all breast cancer patients and provide financial assistance to the underserved for lymphedema therapy and compression garments. A Susan G. Komen grant of $49,600 was awarded. Personalized sessions were held, including verbal instructions and written materials specific to risk factors, signs/symptoms, and early interventions for lymphedema. Financial need was based on assessment by the BCN or CLT after discussion with patients. Patients with identified financial barriers received assistance and were referred to CLTs or certified fitters for lymphedema therapy and/or compression garments.
Results: During the 18-month grant period, the BCN or CLT provided teaching sessions to 130 patients. Financial assistance was provided to 93 under/uninsured patients. Therapy alone was provided to 5 patients, therapy and garments to 26 patients, and garments alone to 62 patients. The average financial assistance provided was $533. Treated patients had an average limb size decrease of 6.4 cm.
Conclusions: Implementation of the standardized education process was successful and continues to be reinforced through long-term survivorship care. However, financial barriers continue to exist for many patients. Currently, our breast program is advocating for an on-site CLT. We continue to pursue grant opportunities to overcome the financial barriers of lymphedema care.
- Fu MR, Chen CM, Haber J, et al. The effect of providing information about lymphedema on the cognitive and symptom outcomes of breast cancer survivors. Ann Surg Oncol. 2010;17:1847-1853.
Pathway of a Positive Breast Biopsy: Reducing Testing to Treatment Times
Linda Byrd, ADN, RN-BC, CGRN
Emory Saint Joseph’s Hospital, Atlanta, GA
Objective: In a suburban community hospital where turnaround times for hormone receptor reports of positive breast biopsies averaged 8 business days, resulting in delayed initiation of treatment, an interdisciplinary breast team led by the breast navigator set out to revise the hormone receptor analysis process to decrease turnaround time by 20%.
Methods: Retrospective and prospective data collection looking at: date of biopsy to report scan date, order date of hormone receptors to report scan date, e-mail notification from outside pathology vendor to scan date, and pathologist review to same-day report scanning. Weekend days were eliminated from all data sets.
Results: During the initial meeting to discuss the project, the interdisciplinary team quickly identified 2 existing barriers to the current pathway: a 2- to 13-day return delivery on pathology slides from outside vendor, and that pathologists were unaware of the web-based results process. Careful data analysis validated the 2 previously identified barriers and did not identify additional barriers. Workflow revisions included improved communication with the outside pathology vendor for overnight slide return when applicable, the addition of e-mail notification from vendor when results are available, increased utilization of a web-based results reporting process, internal modifications of the result-scanning process, and education to the hospital pathologists concerning the process changes. These changes, identified through detailed data collection and interdisciplinary collaboration, yielded a decrease in turnaround time to 4 business days.
Conclusion: As a result of interdisciplinary collaboration, the team achieved a 50% reduction in the number of business days from the time of breast biopsy to availability of hormone receptor results, thus expediting initiation of treatment, decreasing psychosocial distress, and improving patient satisfaction. The team identified the benefit of having a dual role of diagnostic and oncologic navigator who had the ability to identify the issues surrounding turnaround times. This project highlights the importance of nurse navigators and interdisciplinary collaboration and demonstrates how they positively affect healthcare and patient outcomes.
Prevention of Everolimus/Exemestane (EVE/EXE) Stomatitis in Postmenopausal (PM) Women with Hormone Receptor–Positive (HR+) Metastatic Breast Cancer (MBC) Using a Dexamethasone-Based Mouthwash (MW): Results of the SWISH Trial
Lindsay Shelby, RN, OCN1; Hope S. Rugo, MD2; Lasika Seneviratne, MD3; John A. Glaspy, MD4; Julio A. Peguero, MD5; Timothy J. Pluard, MD6; Navneet Dhillon, MD7; Leon C. Hwang, MD8; Chaitali Nangia, MD9; Ingrid A. Mayer, MD10; Timothy F. Meiller, DDS11; Mark S. Chambers, DMD12; Jaqueline Rogerio, MD13; Kristina Wagner, MS13; Robert W. Sweetman, MD13; J. Randy Sabo13; J. Thaddeus Beck, MD1
1Highlands Oncology Group, Rogers, AR; 2University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; 3Los Angeles Cancer Network, Los Angeles, CA; 4University of California Los Angeles School of Medicine, Los Angeles, CA; 5Oncology Consultants P.A., Department of Research, Houston, TX; 6St. Luke’s Cancer Institute, Kansas City, MO; 7Cancer Treatment Centers of America, Atlanta, GA; 8Kaiser Permanente Mid-Atlantic States, Gaithersburg, MD; 9UC Irvine Health Chao Family Comprehensive Cancer Center, Orange, CA; 10Vanderbilt-Ingram Comprehensive Cancer Center, Nashville, TN; 11Oncology and Diagnostic Sciences, Dental School and The Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland Medical Center, Baltimore, MD; 12The University of Texas MD Anderson Cancer Center, Houston, TX; 13Novartis Pharmaceutical Corporation, East Hanover, NJ
Objective: Stomatitis is a common adverse event (AE) of mTOR inhibition. In BOLERO-2, all-grade (Gr), Gr ≥2 and 3 stomatitis incidence with EVE/EXE was 67%, 33%, and 8%, respectively. Median time to Gr ≥2 onset was 15.5 days; incidence plateaued at 6 weeks. In a meta- analysis of stomatitis among phase 3 trials, 89% of first stomatitis events occurred within 8 weeks. Topical steroids are used to treat aphthous ulcers; anecdotal use as prophylaxis has been reported. Prospective studies are ongoing to investigate prophylactic steroid-based rinses to prevent stomatitis. Nurses are critical in educating patients about and treatment of AEs. The SWISH trial evaluated prophylactic use of dexamethasone (DEX) MW in preventing stomatitis in PM women with HR+ MBC receiving EVE/EXE.
Methods: Eligible patients prescribed EVE 10 mg/EXE 25 mg QD received a commercially available alcohol-free DEX 0.5 mg/5 mL solution, 10 mL swished × 2 min and spit QID × 8 wks. Oral antifungal prophylaxis was optional. Patients completed a daily log for adherence, oral pain, and normalcy of diet scores. The primary end point compared the incidence of Gr ≥2 stomatitis at 8 weeks with BOLERO-2 results.
Results: Ninety-two patients enrolled; 86 were evaluable for efficacy. Median age was 61 years; >35% were treated with EVE/EXE in the ≥2nd-line setting. Twenty patients used antifungal prophylaxis. Incidence of Gr ≥2 stomatitis at 8 weeks was 2.4% versus 33% in BOLERO-2. Incidence of all-grade stomatitis at 8 weeks was 21.2% versus 67% in BOLERO-2. The rate of Gr 1 stomatitis was 18.8%. Median dose intensity was 10 mg and 25 mg for EVE and EXE, respectively. Ninety-five percent of patients used MW 3 to 4 times/day (median uses/day = 3.95). In the 75 patients with complete ECOG scores, 88% maintained/improved ECOG status. Mean pain scale score was <1 (very little pain) at all visits; 88% of patients reported normal diet at 8 weeks. Thirteen percent discontinued EVE/EXE due to suspected related AEs (most common: rash, hyperglycemia, and stomatitis [2% each] and pneumonitis [1%]). Oral candidiasis was reported in 2 patients; both patients used antifungal prophylaxis. Overall, DEX mouthwash was well tolerated with minimal toxicity.
Conclusions: Prophylactic use of 0.5 mg/5 mL DEX oral solution markedly decreased the incidence and severity of stomatitis in patients receiving EVE/EXE for MBC and should be considered a new standard of care in this setting. It is important to counsel patients on strategies to prevent stomatitis, such as DEX MW, prior to initiating EVE/EXE therapy.
Sponsorship: This study was sponsored by Novartis Pharmaceuticals Corporation (NCT02069093).
The Breast Imaging Nurse Navigator: Measuring the Impact on Coordinated Care Delivery – Results After the First Year
Sharon Inzetta, RN, MS, CBCN, CN-BN
Summa Health System Akron City Hospital Breast Center, Akron, OH
Objectives: Access, timeliness, patient satisfaction, and outmigration for breast care delivery were all identified as areas for process improvements in our community hospital breast center. In 2015, a dedicated imaging nurse navigator was added to our interdisciplinary breast team. The imaging nurse navigator would develop and define navigation, assessing barriers for access, improving timeliness, decreasing outmigration, and empowering and advocating for breast care that is patient centered and evidenced based. The imaging nurse navigator developed survivorship education and programming targeting adopting healthy lifestyle behaviors, cancer prevention, and decreasing cancer recurrence.
Methods: The dedicated imaging nurse navigator began seeing and tracking all patients January 2015 through December 2015. Patients were navigated and a diagnostic plan of care was completed for follow-up referrals to a dedicated breast specialist. The breast program leadership established the time from abnormal imaging to biopsy as 7 days. The imaging nurse navigator would impact outmigration by coordinating surgical consults within 48 hours. The imaging nurse navigator would develop survivorship programming through education and exercise.
Results: The imaging nurse navigator has been integral in impacting access, timeliness, and satisfaction with breast care delivery. Reduction in time from abnormal breast finding to biopsy decreased from 26 days in 2014 to 11 days. The imaging nurse navigator improved outmigration in 2015, from 5% to 1% of patients after 12 months. Navigational intervention at the point of an abnormal finding with breast imaging has resulted in increased patient volumes. The navigator has shown 234 additional cases in 2015 for breast care follow-up, referrals, and breast biopsies. Imaging nurse navigation has resulted in monthly increases in patient volumes that significantly impact overall financial increases attributed to navigational care. The imaging nurse navigator coordinated referral to the breast specialist targeting the 48-hour benchmark, showing significant improvement in access and increase in volumes across program breast specialty providers. Same-day referrals occurred in 38% of patients compared with 4% in 2014. Additional benefits of having a nurse navigator resulted in development of survivorship programming; a preoperative Breast Cancer 101 class, an Integrative Survivorship Journal Club, and Ready SET GO–Survivors Exercising Together, providing navigational support across an ongoing care continuum.
Conclusions: Implementation of the imaging nurse navigator role has helped remove barriers for breast care delivery surrounding access, timeliness, volumes, and outmigration. The imaging nurse navigator has been shown to be integral to breast care delivery improving patient and provider satisfaction and increasing financial success of the breast program.
Using the Power of Design to More Effectively Communicate with Metastatic Breast Cancer Patients, the “Dandelion Toolkit”
Corrine Ellsworth Beaumont, PhD1; Katherine Crawford-Gray, MBA, MSc2
1WorldwideBreastCancer.com; 2Metastatic Breast Cancer Alliance
Background: Metastatic breast cancer (MBC) patients receive an overwhelming amount of information at the time of diagnosis, with most of the information transferred through oral conversations and abstract medical terminology that’s difficult for patients to understand. Oral conversations have a low accuracy memory recall of 14%.1 However, when visuals are integrated into discussions, the accurate memory recall of conversations has a median of 80%.2 We ask, “How can nurse navigators help patients feel informed, empowered, and more easily communicate with their healthcare team on a more equal level through using a visual toolkit to guide the discussions?”
This paper describes both the process and outcomes of developing a visual conversation aid, the “Dandelion Toolkit.”
While several resources3-6 offer advice and guidelines on how to develop materials for specific audiences, a holistic, patient-centered, defined framework could help nurse navigators structure the development and testing of materials.
Objectives: 1) Develop a visual aid for helping MBC patients and healthcare providers (HCPs) improve their communication during initial diagnosis and treatment discussions; 2) design a set of visual tools to communicate in a time-effective way and appeal to a wide demographic of MBC patients of various literacy levels; and 3) increase patient engagement in treatment decisions despite emotional distress.
Toolkit Development Methods: The toolkit was developed following the “U.S.E.R.” (User, System, Establish, Realize) Design Thinking Framework.7 This patient-centered, mixed-method approach used action research, iterative prototyping, interviews, and co-creative methods to identify problems and develop solutions within the health system, working with >80 MBC patients and HCPs.
Results: The U.S.E.R. design process offered an organized and holistic framework to involve both MBC patients and HCPs in the development of a communication tool. User testing was done throughout the development, which resulted in an evidence-based solution delivered in a short time frame (2 months). The design outcome was a visual metaphor that visualized the behavior, subtype, and treatment options for metastatic cancer. Initial testing of the toolkit in a community cancer clinic revealed it was highly valued by patients and HCPs. HCPs who used the toolkit found the visual approach offered a better method for educating patients as opposed to oral communication alone; it aided in simplifying treatment options, managing patient anxiety, and navigating difficult topics. Patients found that the metaphor helped them to understand more comprehensively what a metastatic diagnosis meant and the spectrum of treatments; the toolkit helped them navigate conversations with other healthcare professionals and family members and to feel an improved sense of control.
Conclusions: Initial testing demonstrated the effectiveness of the toolkit developed with the U.S.E.R. Design Thinking Framework for both HCPs and MBC patients. To more fully investigate the toolkit, it is now being used in clinical trials across 7 sites nationwide and internationally. This will provide data to better understand the toolkit’s impact on patient knowledge, HCP effectiveness, and best practices for integrating visuals into discussions for improved patient experience.
- Houts P, Witmer JT, Egeth HE, et al. Using pictographs to enhance recall of spoken medical instructions. Patient Educ Couns. 2001;43:231-242.
- Kessels RP. Patients’ memory for medical information. J R Soc Med. 2003;96:219-222.
- Simonian K, Sanders DB, Murillo VE, et al. Breast Health and Breast Cancer Informational Needs of Young Women and Women of Color 40 and Older. Susan G. Komen for the Cure. 2007.
- NHS. Design advice. NHS Brand Guidelines. www.nhsidentity.nhs.uk/all-guidelines/guidelines/general-practitioner/practice-leaflets/design-advice. June 25, 2008.
- Szebeko D. Co-designing for communications and services in the healthcare environment. Journal of Public Mental Health. 2005;4(4):42-47.
- Breslin M, Mullan RJ, Montori VM. The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. Patient Educ Couns. 2008;73:465-472.
- Beaumont C. Design Thinking in Healthcare: Developing Patient-Centred Communication Materials for Breast Cancer Detection. PhD Thesis. 2011. Brunel University, England.