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M. Hesdorffer

Moderator of

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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: 6
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      GR02.0 - N/A - Chair Intro (ID 450)

      10:30 - 10:35  |  Author(s): M. Culligan

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      GR02.1 - Affirmative (ID 451)

      10:35 - 10:50  |  Author(s): P. Yates

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      GR02.2 - Affirmative (ID 452)

      10:50 - 11:05  |  Author(s): J. White

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      GR02.3 - Negative (ID 453)

      11:05 - 11:20  |  Author(s): M. Culligan, M. Hesdorffer, Y. Lai, P. Yates, J. White, C. Broderick

      • Abstract
      • Presentation
      • Slides

      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.

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      GR02.4 - Negative (ID 454)

      11:20 - 11:35  |  Author(s): Y. Lai

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      GR02.5 - Discussion (ID 455)

      11:35 - 12:00  |  Author(s): N. n/a

      • Abstract

      Abstract not provided



Author of

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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: 1
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      GR02.3 - Negative (ID 453)

      11:05 - 11:20  |  Author(s): M. Hesdorffer

      • Abstract
      • Presentation
      • Slides

      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.

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    MO27 - Patient Centred Care (ID 141)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Nurses
    • Presentations: 1
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      MO27.11 - DISCUSSANT (ID 4013)

      11:25 - 11:40  |  Author(s): M. Hesdorffer

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    MTE17 - Nursing Goes Global - Meeting the Challenges Posed by Mesothelioma (ID 61)

    • Event: WCLC 2013
    • Type: Meet the Expert (ticketed session)
    • Track: Mesothelioma
    • Presentations: 1
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      MTE17.1 - The Driving Force of Social Networking (ID 611)

      07:05 - 07:20  |  Author(s): M. Hesdorffer

      • Abstract
      • Presentation
      • Slides

      Abstract
      The Driving Force of Social Networking According to Facebook executives, the social network reports 1.06 billion monthly active users. This number has been steadily increasing with a 25% increase in monthly users from last year and a rise of 28% in daily users. Now that we know the numbers what is happening in the world of patients. Though the premise exists that Facebook is strictly for social media networking, I wouldn’t hesitate to guess that patients, especially those who are home bound, spend an enormous amount of time on the web. Patients with rare diseases, in particular, have found Facebook to be a useful tool in finding others facing similar circumstances. PatientsLikeMe.com, launched in 2004, uses a number of tools to collect data and derives a hefty profit from selling this data to pharmaceutical companies as well as research institutions. It reports over 200K users on the site covering 1800 diseases. It uses sophisticated questionnaires to gather data about its users. Another active social media network, 23andme.com promotes the selling of an at-home saliva kit to map out genetic codes. They provide users with interactive tools meant “to shed new light on your distant ancestors, your close family and most of all, yourself.” In 2013, this company spent up to $5 million in advertising, further demonstrating that healthcare on the web is a lucrative field. Law firms representing mesothelioma patients spent over $50 million in goggle keyword advertising in 2012, making mesothelioma the most expensive word in Google advertising. Many of the larger firms representing victims of asbestos have now also launched Facebook pages and groups. These are usually marketed as patient support and advocacy sites providing patients with support and referrals to both medical and legal professionals. To the unsuspecting patient, these sites appear to be either VA sponsored or true advocacy sites which could not be further from the truth. Do you really want your patients to receive medical advice and referrals from representatives of legal entities or other for-profit operations with secondary motives? Nurses are the most trusted professionals valued by the public according to numerous surveys. Who is better equipped to engage with patients in social media and help them to understand the “rules of engagement”? The median age for the diagnosis of lung cancer is 72 and for mesothelioma 70. People in their 70s are less likely to be knowledgeable about the risks vs. the benefits of engaging in social media networking. We are all too familiar with the patient or family members who present to the office armed with paperwork obtained during web searches. Some of the information is valuable, but much is not applicable to their current situation and some is entirely misleading. An inordinate amount of time is consumed by those affected by the disease and the practitioner sorting through and commenting on relevancy of such information. I would suggest that if a nurse could guide their navigation of the web and provide accurate medical information and accurate interpretation of this information, the patient and their representatives as well as the provider could have a more focused discussion. Social media provides a unique opportunity to capture large numbers of patients and their advocates which can be used as a tool for both education and support. It would be the role of the nurse to explain the workings of the platform and to set guidelines to assist in protecting privacy to the degree possible when engaging on these sites. Patients need to understand the potential consequences of engaging in online health-related discussions and must be willing to accept the risks associated with membership in a group. It is fairly common for potential employers to peruse Facebook pages to gather additional background information on future employees. It could certainly be feasible that health insurance companies, especially if a dispute arises, might also turn to social media for information. Patients should be encouraged to read the privacy policy on these sites and an open dialogue about privacy within the group should be an ongoing. Patients themselves are the driving force in this healthcare-related online movement. As a result, hundreds of groups run by patients are available for others to join and this is where this trend can become problematic. Patients with the loudest voice on Facebook, or perhaps the miracle responders, can sway a captive patient group into potential risky decisions with the best of intentions. Groups starting off as support groups can quickly and unexpectedly have their conversations shift toward sharing of medical information and practice. As nurses, we know that patients need to be fully informed without bias to be able to practice good decision-making. Nurse-led groups can promote support and can help to guide the conversation to avoid misinformation or “cyber opinion bullying” by the strongest patient leader. Nurses can designate a peer group leader but promote their role within the group as the medical monitor. This provides an opportunity to gently correct misinformation and present new medical information to the group thus maintaining professionalism and the integrity of the group. Patients with rare diseases are often isolated and local support groups may not be applicable to their particular situation. Patients in these groups often express relief that they are able to connect with others in similar circumstances. However, connecting with others in this manner can be bittersweet. The group can celebrate the victories but will also mourn setbacks and death of group members. Having a nursing professional in the group provides access to a trained individual who can assist in emotional healing as well as recognize and refer if group members need one on one counseling. In cancer, less than 10% of all patients enroll in clinical trials. As nurses we can educate patients about clinical trials and promote participation in such trials. Cancer patients are seeking knowledge on the web, and as educators, it is our role to see that this need is met. T

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