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GR02 - Is There a Role for the Thoracic Oncology Nurse in Ensuring Patients with an Advanced Lung Cancer have Access to Early Phase Clinical Trials? (ID 17)
- Event: WCLC 2013
- Type: Grand Round Session
- Track: Nurses
- Presentations: 2
- Moderators:C. Broderick, M. Hesdorffer
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside Gallery A, Level 1
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GR02.1 - Affirmative (ID 451)
10:35 - 10:50 | Author(s): P. Yates
- Abstract
- Presentation
Abstract not provided
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GR02.3 - Negative (ID 453)
11:05 - 11:20 | Author(s): P. Yates
- Abstract
- Presentation
Abstract
Cancer is the leading cause of death in the world, accounting for approximately 7.6 million deaths in 2008. Lung cancer accounted for 1.37 million of those deaths.Identification of molecular markers in lung cancer has lead to the development of targeted therapies resulting in improved survival in selected groups of lung cancer patients. Despite the advancements in treatments, the survival for patients with lung cancer, particularly in the metastatic or locally advanced patients (stage IIIb/IV), is generally poor with a 5-year survival of only 6%. The current poor prognosis and latest advances made in the field of lung cancer highlight the importance of clinical trial development, participation and analysis. Participation in clinical trials for the general cancer patient’s is low, between 5-9%. This low percentage is similar to those seen for lung cancer patients. Early stage clinical trials have a smaller number of participants by design and are aimed at establishing a maximum tolerated dose of a drug or treatment, not establishing efficacy.These clinical trials are not designed with curative intent but rather are designed to evaluate drug absorption, distribution, metabolism, excretion and mechanism of action. Only a small number of cancer patients and even a smaller number of advanced stage lung cancer patients enroll into phase I clinical trials. The number of international clinical trials has seen a rapid increase over the past decade. Recently the Office of Inspector General (OIG) reported that as of 2008, 80% of marketing applications for drugs and biologics approved by the US Food and Drug Administration (FDA) contained data from US clinical trials conducted outside of the USA. Despite the importance and availability of clinical trials for lung cancer, participation in early stage clinical trials by advanced stage lung cancer patients remains very low. There are multiple barriers that contribute to these low numbers of participants, some of which include: (1) fear of unknown benefit from the investigational treatment, (2) negative family and family physician influence, (3) logistical and attitudinal constraints – too cumbersome to participate and not willing to be the subject of “experiments”, (4) lack of knowledge, understanding and fear of the complexities of the clinical trial, (5) risk of inability to tolerate related investigational drug / treatment toxicity due to more weaken condition and (7) financial and insurance barriers.Identifying and overcoming the barriers that exist for each patient early in their diagnosis has the potential to improve both the quality and quantity of their lives and potentially help others with the same barriers in the future. Another significant barrier is the real and perceived conflict that exists between the need for palliative and/or Hospice levels of care for advanced stage lung cancer patients. The need for Hospice benefits and palliative care can and does have a significant impact on the decision to participate in early stage clinical trials to the point that participation may not even be an option. Funding and other system related issues act as barriers to participation in early stage clinical trials as well as the philosophical basis of the hospice/palliative care approach to treatment/care. Over the past decade the availability of symptom management and palliative care clinical trials has increased the awareness of this barrier and in many respects further clouded the issue for patients, their families and their healthcare providers. The primary ethical concern is does enrollment into clinical trials interfere with the spirit of hospice care or does it offer hope to a dying patient? Identifying issues that exist globally may help to increase enrollment by advance stage patients while at the same time moving early phase clinical trials forward and onto the phase II/III stage of study. Phase I trials are not designed with curative intent and phase I agents are not likely to prolong life or change the course of a disease. The life expectancy of phase I cancer patients’ averages between 5-6.5 months. Hospice providers and research investigators are in agreement that phase I clinical trials should be open and available to advanced stage lung cancer patients who are concurrently enrolled in hospice care. Overcoming the barriers and obstacles for advanced stage lung cancer patients to participate in early stage clinical trials can only happen in the setting of a committed multidisciplinary research team.Methods to utilize in an effort to move toward that goal include: (1) recognizing the importance of patient and family education, (2) recognizing the importance of healthcare provider education and awareness, (3) careful review and reinforcement of the informed consent process, (4) identifying and recognizing the potential benefit of phase I clinical trial enrollment for advanced stage lung cancer patients – clinical and altruistic, (5) recognizing and assisting patients and families with individual barriers and obstacles to participation and (6) employing effective marketing, recruiting and screening methods that are multidisciplinary in approach. Thoracic Oncology Nurses are well suited to serve as educators, advocates, resources, facilitators, and intermediaries. Nurses traditionally spend a greater amount of time in direct patient care and family interaction. Expanding and clarifying clinical information patients receive from their treating physicians is a vital role nurses play in ensuring patients are well informed and compliant with their plan of care. This is a model that can and has been extended into the realm of clinical trial work.Studies have shown that nurses play an important role in educating and recruiting cancer patients in clinical trials.A randomized clinical trial compared nurses with surgeons recruitment of patients into a clinical trial for prostate cancer and the results indicated that surgeons and nurses were equally as effective in their recruiting and educating abilities and effectiveness. With the proper education about early stage clinical trials, the conduct of clinical research, knowledge of the disease process of advance stage lung cancer and a high degree of self-motivation, thoracic oncology nurses are well suited to improve access and enrollment of advanced stage lung cancer patients into early phase clinical trials.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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O26 - Support and Palliation II (ID 140)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Nurses
- Presentations: 1
- Moderators:J. White, Y. Lai
- Coordinates: 10/29/2013, 16:15 - 17:45, Bayside 104, Level 1
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O26.08 - DISCUSSANT (ID 4011)
17:30 - 17:45 | Author(s): P. Yates
- Abstract
- Presentation
Abstract not provided
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