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Lavinia Dobrea
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MS 10 - Evidence Based Care: Interpreting the Research and Enhancing Practice (ID 532)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Nursing/Palliative Care/Ethics
- Presentations: 1
- Moderators:Caitlin Broderick, Pippa Labuc
- Coordinates: 10/16/2017, 15:45 - 17:30, F205 + F206 (Annex Hall)
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MS 10.03 - Community Outreach - Engaging in Primary Care (ID 7691)
16:25 - 16:45 | Presenting Author(s): Lavinia Dobrea
- Abstract
- Presentation
Abstract:
Background/Objective: Lung cancer clinical trials are critical to advancing our understanding of disease characteristics, diagnostic criteria and treatment options. With evolving molecular testing and immunotherapies, clinical trials are increasingly complex and challenging to conduct at the site level. This report highlights the role of the Lung Cancer Clinical Research Nurse (LC-CRN) as vital to supporting patient participation and physician involvement for lung cancer trials. We also review new challenges with immunotherapies, nuances of sending tissue for molecular testing and importance of managing patient and family expectations. Methods: The St. Joseph community hospital multidisciplinary Thoracic Oncology Program was established in 2004, averaging 150 lung cancer patients annually. Since 2013, we facilitated efforts to increase participation in research studies. Strategies included (1) streamlining practices within the internal program structure and catalyzing efforts to acquire novel trials, (2) training a specialized LC-CRN to efficiently screen patients to exclusion criteria, and (3) enhancing enrollment and retention practices. Results: To streamline our portfolio, we closed stagnant trials and prioritized non-competing trials with novel agents of interest to our providers that address particular needs of our community population. Since 2013, lung studies open to accrual have tripled and patient enrollment continues to increase in both clinical trials and donations to our tissue biorepository. Current lung trials include diverse standard-of-care options alongside immunotherapies, genomic profiling, tissue biorepository, a tumor device and liquid biopsy trial. Responsibilities of the LC-CRN are to engage physicians, identify and accrue patients, coordinate specimen requirements, ensure protocol and ethics compliance, and communicate readily with study team and sponsors. At our site, specialized LC-CRN training included NCCN guideline review, sponsor visits for protocol training, creating and utilizing simple recruitment and screening tools, flyers and worksheets. The LC-CRN provides routine education about available and upcoming trials at weekly thoracic tumor boards, using visual aids to simplify comparisons of patient entry criteria across multiple studies. In partnership with study investigators, LC-CRNs are uniquely skilled to simplify clinical trial summaries to patients and communicate study content and patient commitment. LC-CRNs must have a robust understanding of disease processes and standard oncology treatment guidelines, including mutation testing. The LC-CRN must also be well acquainted with lung research protocols to advise providers of required tests/procedures, treatment/dosing, and management of adverse reactions. During the consent review, study visits and follow-ups, the LC-CRN must address patient concerns and assess key areas for further education. Effective communication with study sponsors include proper charting and documentation, data entry and responses to queries, as well as record submissions for billing/insurance processes unique to the study or healthcare setting. We implemented recruitment and retention processes supported by literature to ensure a majority of new and recurrent lung cancer patients are considered for clinical trials. Patient cases are presented at multi-disciplinary tumor boards and lung program meetings for group discussions. A recent publication noted higher physician engagement at tumor boards correlated with increased patient accrual and satisfactory prognostic outcomes (Kehl et al., 2015). The LC-CRN also cross-collaborates with navigators, genetics counselors, infusion nurses, radiation staff and others to identify and manage study patients. Literature noted early and repeated presentation of trial information during patient visits boosted trial participation to over 50% of 309 patients with thoracic malignancies (Logan et al., 2017). The close relationship of the LC-CRN to patients and their care team may avoid patient dropout, which often occurs due to misinformation or non-compliance to complex oncology study protocols (McCarthy-Keith et al., 2010). Routine clinical guidance throughout treatment remains important for research engagement and addressing specialized needs of lung cancer patients (Islam et al., 2014; Mosher et al., 2017). Common challenges with immunotherapies include identifying immunotherapy adverse events (IrAEs), fulfilling tissue requirements for molecular testing, and managing patient/family expectations. Research teams ensure ongoing dialogue and education with patients to promptly address IrAEs. We conduct a protocol “dry run” with the clinic staff, pharmacist, hospital facilities director and safety manager to ensure compliance of agent preparation, delivery, spill preparedness and IrAE management. We also oversee tissue acquisition and processing, as it can be a significant barrier to enrollment and retention (Lim et al., 2016). Fresh tissue, via core or excisional biopsies, is often required over archived tissue at study entry, progression or change of treatment. Collaborations with our pathologist, interventional radiologist, finance team and technicians ensure timeliness and correct acquisition methods over multiple time points. With the emergence of personalized immunotherapies come high hopes, but also fears and misconceptions about drug capabilities and efficacy in treatment regimens. The LC-CRN can readily distinguish and manage family and patient expectations by conducting extensive and ongoing teaching about medical use, potential benefits and dangerous side effects. In one setting, 85% of 40 lung and esophageal cancer patients were satisfied with trial participation following a positive experience with a study navigator (Cartmell et al., 2016). Strategies utilizing dedicated staff members, such as a LC-CRN, are necessary in guiding and educating patients about research concerns and processes. Overall, the LC-CRN and thoracic oncology care team are intimately involved in addressing patient expectations and care management to maximize research participation and patient outcomes in oncology care. Conclusion: The landscape of lung cancer diagnosis and treatment is quickly shifting. A durable and flexible research infrastructure includes having an active multidisciplinary thoracic team with dedicated staff advocating for patient access to clinical trials. The role of the LC-CRN in supporting participation in lung cancer trials is vital. With proper education and training, the LC-CRN is best positioned to support patient participation, physician involvement and patient/sponsor expectations in lung cancer trials. REFERENCES Cartmell KB, Bonilha HS, Matson T, Bryant DC, Zapka JG, Bentz TA, Ford ME, Hughes-Halbert C, Simpson KN, Alberg AJ. Patient participation in cancer clinical trials: A pilot test of lay navigation.
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P3.10 - Nursing/Palliative Care/Ethics (ID 726)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Nursing/Palliative Care/Ethics
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.10-004 - Immunotherapy: Emergency Department Provider Needs Assessment Survey (ID 10359)
09:30 - 09:30 | Presenting Author(s): Lavinia Dobrea
- Abstract
Background:
Globally, lung cancer is the second most common cancer diagnosis and the leading cause of cancer death (WHO, 2017). Over the last decade, many efforts have focused on lung cancer prevention, early diagnosis, and finding more effective treatments. In the last two years, the FDA approved of a new class of medications called checkpoint inhibitors or immunotherapy, with proven efficacy in treating advanced lung cancer and several other malignancies. These drugs incite the immune system, resulting in unique immune-related adverse events (irAEs) which are difficult to diagnose, challenging to manage, and potentially life threatening if not properly assessed and managed. Diagnosis of irAEs are typically made on exclusion. It is vital that the medical team and supportive services have current and accurate knowledge on these therapies when patients present for work up during flare-ups.
Method:
A needs assessment survey was given to St. Joseph Hospital Emergency Care Center (ECC) providers and Registered Nurses at a department staff meeting. A one page pre in-service survey was administered in English only, followed a brief in-service, and a post in-service survey immediately followed. The Pre and post survey was used to evaluate effectiveness of teaching. Sample size: 20 MD’s or PA’s and 65 NP’s or RN’s. Selected questions assisted in identifying knowledge deficits among St Joseph Hospital ECC physicians and registered nurses. We were able to evaluate the effectiveness of teaching, and obtained feedback on the value of implementing an immunotherapy patient identification card. Knowledge of immunotherapy side effect management was measured with an identical pre and post in-service survey. The survey contained 5 items that measured the individual’s current knowledge/comfort with managing immunotherapy side effects for oncology patients receiving immunotherapy who are evaluated in St. Joseph Hospital Emergency Department. The questions were developed in conjunction with our current and prior Thoracic Oncology Program Medical Directors.
Result:
Data was analyzed with the Wilcoxon Statistic Responses. We identified a significant knowledge gap by our ECC providers at our institution. These providers are often the first to assess irAEs when patients present to the hospital with significant medical issues. Teaching intervention was effective as evidenced by post test results.
Conclusion:
IrAEs is a vital and relevant topic for our patient populations. ECC providers and our multidisciplinary providers are supportive of introducing Immuno-Oncology patient wallet cards and further education on Immunotherapy. Future projects include implementation of ISLAC’s irAEs management guidelines.
