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P. Hollen

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    MS 19 - Global Nursing Issues in Lung Cancer (ID 37)

    • Event: WCLC 2015
    • Type: Mini Symposium
    • Track: Nursing and Allied Professionals
    • Presentations: 6
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      MS19.01 - Nursing Challenges in Clinical Trials (ID 1931)

      14:20 - 14:33  |  Author(s): C. Oyen, S. Lepers, L. Peeters, C. Dooms, K. Nackaerts, J. Vansteenkiste

      • Abstract
      • Presentation
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      Abstract:
      Background: The model of clinical trials in lung cancer has evolved quite dramatically over the past years. Expanded phase I trials in biomarker-driven populations are a new paradigm of accelerated drug approval. Enrolling patients in these clinical trials creates several new challenges. Clinical Research Nurses (CRNs) play an important role in recruitment, actual drug delivery, and monitoring of this whole process. Methods: Identify the different barriers to recruitment that CRNs face with these clinical trials. Barriers to participation can be patient-related, physician-related or tissue-related. Review of literature was the basis for the patient- and physician-related barriers. To identify the tissue barriers, we studied our own database. We also present practical tips to overcome these barriers out of own expertise in the field. Results: Patients’ barriers to participate in clinical trials include individual characteristics, practical issues, and attitudes. The most common barriers are the individual characteristics: cultural background, health literacy, ethnicity, and age. Lack of knowledge, insurance coverage, extra appointments, reimbursement, and patient ineligibility are typical practical barriers. Attitudinal barriers are reluctance to randomisation, fear for side effects, and efficacy concerns (e.g. allocation to placebo) (1-3). To overcome these barriers the trial should be explained clearly. Patient should be supported in what may be a difficult decision and should not be pressured to do so. Dedicated CRNs may help with monitoring the recruitment process, providing additional information, and obtaining informed consent (1). The process of informed consent is the optimal time to define clearly the terms of the clinical trial, and to explain the sometimes difficult to understand medical and legal terms in the informed consent document. Optimally, this should lead to good understanding by the patient of the potential benefits and risks (4). Main physicians’ barriers are lack of time due to competing priorities, insufficient staff and training to meet the ever increasing procedures from competent authorities or institutional review boards and finance departments, worry about the impact on the doctor-patient relation, concern for patients, and lack of reward and recognition. Lack of time is considered a major barrier. Doctors experience time pressure from their usual clinical practice and management duties. Recruitment, the consent process, and the follow up of clinical trials on top of that demand a large piece of extra time (1;4;5). Lack of support staff, for example CRNs, can also account for poor recruitment. A stable clinical research team is likely to be advantageous. CRNs should not only have expert clinical and well developed critical thinking skills, but be well acquainted with the complex scientific, regulatory, and ethical aspects of clinical research (6). Well trained and experienced CRNs truly are “PI-extensions”. By monitoring the clinical activity to find possible candidates for trials, they support the physician with recruitment, and later on with the follow-up of included patients. Over the last years, we saw a major progress in the treatment of advanced non-small cell lung cancer, largely due to new targeted agents, monoclonal antibodies, and immunomodulatory agents. Both in clinical practice, as well as in clinical trials, the availability of tissue for biomarker analysis – in order to make the best choice for the patient – is crucial. Tissue availability is a new important barrier to clinical trials, as we noted from our own experience (7). Moreover, central lab confirmation of an already known biomarker, is often requested before the patient is allowed to start therapy, leading to sometimes important delays. In our respiratory oncology trial unit, we analysed of our molecular database regarding this barrier (7). The mean waiting time between signing informed consent and receiving results of the biomarker analysis from the central laboratory turned out to be 25 calendar days! While delivering a tissue sample for central confirmation of molecular testing is crucial in biomarker-driven NSCLC trials, the mandatory waiting of patients to start therapy is to be discussed. Waiting times for central laboratory analysis not only lead to an important delay in treatment initiation, but even ineligibility for the trial(s) under consideration. Start of therapy based on a properly validated local test, with a posteriori central biomarker testing to guarantee the integrity of the trial, would be more rewarding for quite some patients (8). Conclusion: Recruitment in lung cancer clinical trials is a complex and vulnerable process with different types of barriers. Identifying such barriers can help clinical trial staff to develop strategies to optimize participation and cooperation. Well-trained CRNs have a unique knowledge and set of skills that allows them to make a significant contribution to the clinical research team. CRNs should follow the rapid change in clinical trials closely, so that they can be a guide for patients in their clinical trial journey. Moreover, they have an important role in minimising the patient barriers, give support in physician barriers, and facilitating tissue barriers. References (1) Ross S, Grant A, Counsell C et al. Barriers to participation in randomised controlled trials: A systematic review. J Clin Epidemiol 1999;52:1143-1156. (2) Manne S, Kashy D, Albrecht T et al. Attitudinal barriers to participation in oncology clinical trials: Factor analysis and correlates of barriers. Eur J Cancer Care 2015;24:28-38. (3) Kaplan CP, Napoles AM, Dohan D et al. Clinical trial discussion, referral, and recruitment: Physician, patient, and system factors. Cancer Causes Control 2013;24:979-988. (4) Mills EJ, Seely D, Rachlis B et al. Barriers to participation in clinical trials of cancer: A meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006;7:141-148. (5) Seruga B, Sadikov A, Cazap EL et al. Barriers and challenges to global clinical cancer research. Oncologist 2014;19:61-67. (6) Hastings CE, Fisher CA, McCabe MA et al. Clinical research nursing: A critical resource in the national research enterprise. Nurs Outlook 2012;60:149-156. (7) Lepers S, Ottevaere A, Oyen C et al. The challenge of molecular testing for clinical trials in advanced non-small cell lung cancer patients: analysis of a prospective database. J.Thorac.Oncol. 2015; 10 Suppl: Mini Oral presentation WCLC 2015. (8) Adam V, Dooms C, Vansteenkiste J. Lung cancer at the intensive care unit: The era of targeted therapy. Lung Cancer 2015;E-pub May 18.

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      MS19.02 - Screening for Distress, the 6th Vital Sign - Review and Practical Implications (ID 1932)

      14:33 - 14:46  |  Author(s): M. Ftanou

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      Abstract:
      This paper discusses the prevalence of distress in the lung cancer population, reviews the benefits and barriers of screening and provides practical strategies to implement psychosocial screening. Background: Lung cancer is the leading cause of death by cancer for both men and women worldwide. Most lung cancers are diagnosed at advanced stage and approximately 15% of lung cancer patients will be alive five years post-diagnosis.[1] Psychosocial distress is common for those experiencing cancer. The National Comprehensive Cancer Network (NCCN) defines psychosocial distress as ‘an unpleasant experience of an emotional, psychological, social or spiritual nature, that interferes with the ability to cope with cancer treatment, which extends along a continuum from common normal feelings of vulnerability, sadness and fear, to problems that are disabling such as true depression, anxiety, panic and feeling isolated or in a spiritual crisis’. The NCCN considers distress to be a treatable complication of cancer.[2] Lung cancer patients’ distress levels are among the highest of all cancer types with up to 60% of lung cancer patients experiencing clinical level of psychological distress compared with approximately 35% of patients with other cancer diagnoses.[3 4] These high levels of distress have been found to continue throughout the course of the illness. Prevalence of anxiety and depression in patients with lung cancer ranges from 20% to 50% [3 5] and patients with lung cancer have been identified as having one of the highest rates of suicide within the cancer population. [6] Distress has been associated with a deterioration in quality of life, higher pain levels, increased fatigue, increased family burden and reduced adherence to medical treatments. Despite high levels of distress in this population, lung cancer patients also report experiencing a significantly higher mean number of unmet needs 15.6 (95% CI 12.1–19.1), compared to 10.9 (95% CI 10.0–11.8) in other cancer patients.[7] Psychosocial distress screening Distress screening is defined as "a brief method for prospectively identifying, triaging, and educating cancer patients and their families at risk for illness-related biopsychosocial complications that undermine the ability to fully benefit from medical care, the efficiency of the clinical encounter, patient satisfaction, and safety."[2] Practice clinical guidelines recommend that all cancer patients undergo regular screening, with the American College of Surgeons (ACoS) Commission on Cancer (CoC) requiring cancer centers to implement screening programs for psychosocial distress as a new criterion for accreditation as of 2015. Without formal screening, distress may go unrecognized, clinicians could focus on the medical aspects of the illness and consider distress as a “normal” part of cancer and patients may not be offered effective biopsychosocial treatments to address distress. Without intervention for distress, the distress of lung cancer patients has been found to remain high, post six months of medical treatment.[8] Many tools exist for the screening of distress and these tools have undergone varying degrees of validation in the lung cancer patient group. The Distress Thermometer is the most popular of these tools and has been found to be both acceptable to patients with lung cancer and clinicians. In deciding which distress screening tool to employ, it is important that effective screening takes both disease (i.e. stage of illness, prognosis, side-effects, functional impairment) and demographic risk factors (i.e. age, isolation, past mental health history) into account, is easy to administer and sensitive to the identification of distress. Screening accompanied by discussion with lung cancer patients was found to be more effective than screening alone.[8] Overall, routine screening leads to improvements in communication with patient, families and staff, enhances psychosocial referrals improves symptom management and quality of life. However, some barriers may exist to the successful implementation of routine screening, including: a lack of knowledge about screening; a lack of training about how to manage distress; limited resources and time pressure; lack of institutional support; and a concern that screening may lead to ‘false positives’.[9] Implementing screening for distress recommendation The successful implementation of routing screening needs to be considered at the institutional, multidisciplinary team and individual clinician level. At an organizational level, screening and psychosocial care needs to be valued, prioritized and embedded in policy. Organizations need to ensure adequate psychosocial resources are available, staff are adequately trained and supported and that there is an ongoing evaluation of any psychosocial screening and referral process. At a multidisciplinary team level, the team needs to view psychosocial screening and treatment as part of routine care and distress needs to be assessed across the cancer trajectory, not just at a single point.[10] Treating team members need to consistently inform patients and families that the management of distress is a central part of their medical care. Teams should use a validated and easy to use instrument to assess distress and all screening should be followed by a triage discussion to help formulate treatment plans and referrals. Treatment plans must be clearly documented and communicated to the patient, family and team.[10] At an individual level, clinician should implement policy and procedures that support routine screening and access relevant training, support and supervision. Conclusion Lung cancer patients are among the most distressed and at risk cancer population. Evidence suggests that treating teams must take a person-centred approach to treatment including consideration of patients’ psychosocial needs. Routine screening allows practitioners and treating teams to appropriately consider psychosocial care and engage patients in intervention to minimize the potential negative impacts of untreated or poorly treated distress. References 1. American Cancer Society. Cancer facts and figures 2013. Atlanta, GA: American Cancer Society, 2013. 2. Network NCC. Clinical Practice Guidelines inOncology on Distress Management: National Comprehensive Cancer Network, 2011. 3. Zabora J, BrintzenhofeSzoc K, Curbow B, et al. The prevalence of psychological distress by cancer site. . Psychooncology 2001;10(1):19-28. 4. Graves KD, Arnold SM, Love CL, et al. Distress screening in a multidisciplinary lung cancer clinic: prevalence and predictors of clinically significant distress. Lung Cancer 2007;55(2):215-24 5. Linden W, Vodermaier A, Mackenzie R, et al. Anxiety and depression after cancer diagnosis. Prevalence rates by cancer type, gender, and age. J Affect Disord 2012;;141:343–51 6. Urban D, Rao A, Bressel M, et al. Suicide in lung cancer: who is at risk? Chest 2013;144(4):1245-52 doi: 10.1378/chest.12-2986[published Online First: Epub Date]|. 7. Li J, Girgis A. Supportive care needs: are patients with lung cancer a neglected population? Psycho-Oncology 2006;15(6):509-16 8. Carlson LE, Waller A, Groff SL, et al. Screening for distress, the sixth vital sign, in lung cancer patients: effects on pain, fatigue, and common problems-secondary outcomes of a randomized controlled trial. Psycho-Oncology 2013;22(8):1880-88 doi: 10.1002/pon.3223[published Online First: Epub Date]|. 9. Ristevski E, Breen S, Regan M. Incorporating supportive care into routine cancer care: the benefits and challenges to clinicians' practice. Oncology Nursing Forum 2011;38(3):E204-E11 doi: 10.1188/11.ONF.E204-E211[published Online First: Epub Date]|. 10. Pirl W, Braun I, Deshields T, et al. Implementing Screening for Distress. The Joint Position Statement from the American Psychosocial Oncology Society, Association of Oncology Social Work and Oncology Nursing Society merican Psychosocial Oncology Society, Association of Oncology Social Work and Oncology Nursing Society, 2015.

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      MS19.03 - Trends in Oncology Nursing in Japan (ID 1933)

      14:46 - 14:59  |  Author(s): K. Iino

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      Abstract:
      I am going to introduce the medical care for cancer and nursing for cancer in Japan. Starting from 1981, cancer claimed 1[st] place of the cause of death, and it currently account for approximately 30% of the cause of death. About 900,000 people are annually affected by the cancer. The per category death rate is in the order of lung cancer in 1[st] place, stomach cancer in 2[nd] place, and colorectal cancer in 3[rd] place. The per category affected subject rate is in the order of stomach cancer in 1[st] place, colorectal cancer in 2[nd] place, and lung cancer in 3[rd] place. As you can see from the above, cancer is a serious health problem for Japanese, and although Japan implemented countermeasure for cancer starting from the 60’s, “Cancer Control Act” was established in 2006, and “Basic Plan to Promote Cancer Control Program” was also setup to promote such Act. The purpose of the countermeasure is to do the following: 1.Reduce cancer death (Reduce age-adjusted mortality under 75 years, 2.reduction of burden and improvement of quality of life among cancer patients and their families, 3.Buliding a society in which cancer patients can live peacefully. Based on such backdrop, the role of nurses are further increased. To enhance the specialization of nursing for cancer, “Japanese Society of Cancer Nursing” was established in 1987, and it is now celebrating its 30[th] anniversary. This establishment has been supporting activities such as education and research. Nurses with certification such as “Certified Cancer Nurse Specialist” that can be obtained with completion of master’s course at graduate school, and “Certified Nurse” that can be obtained with 600 hours of education for those with over 5 years of nurse experience are taking active role in the fields of Palliative Care, Cancer Chemotherapy Nursing, Cancer Pain Management Nursing, Breast Cancer Nursing, Radiation Therapy Nursing, etc. Such active role is making positive contribution toward the enhancement of specialization in the clinical field. A variety of issues surrounds the medical care for cancer such as being able to correspond to the advancement of medical technology, increase of cancer survivor, and aging of patients. There is much anticipation for the good use of specialization in the cancer-nursing for team medicine to support the life of patient and to respect the decision-making of patient. I would like to introduce these types of initiatives that are specific to the condition surrounding the nursing for cancer and enhancement of specialized nursing in Japan.

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      MS19.04 - The Importance of Pre- and Early Postoperative Rehabilitation in NSCLC Patient (Design and Rationale for the PROLUCA Study) (ID 1934)

      14:59 - 15:12  |  Author(s): M. Missel, J.H. Pedersen, M.S. Sommer, C. Hendriksen, M. Tewes, L. Adamsen

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      Abstract:
      Background Exercise has been introduced to improve physical capacity (VO~2peak~ and 1RM) and quality of life and to reduce symptoms and side-effects of treatment in patients with cancer, mostly investigated in patients with breast cancer (1,2). Against this background a feasibility study was developed to investigate the safety and feasibility of a preoperative and postoperative exercise program in patients undergoing surgery for lung cancer (3). The study concluded that the preoperative exercise program was not feasible. However, initiation of exercise two weeks postoperatively for patients with NSCLC was safe and feasible. A randomized clinical trial (PROLUCA) was therefore developed to investigate the efficacy of a postoperative exercise intervention in a non-hospital setting. Objectives The objective of the presented study was to explore operable lung cancer patient experiences with the postoperative exercise intervention from a longitudinal perspective according to patient motivation and patient perceived benefits and barriers of exercise. Methods This qualitative component formed part of the randomized control trial (PROLUCA) comparing the efficacy of early initiated postoperative exercise (initiated two weeks after surgery) with the effect of exercise initiated 14 weeks after surgery (usual care). NSCLC patients referred for surgery at the Department of Thoracic Surgery, Copenhagen University Hospital, were recruited for the exercise intervention. More details on the RCT study can be found in the published protocol by Sommer et al. (3). Nineteen patients enrolled in the exercise intervention two weeks post-surgery participated in qualitative interviews at three time points; the day after surgery, 7 weeks post-surgery and 4 months post-surgery. An analysis based on Ricoeur’s theory of interpretation was conducted in a phenomenological hermeneutical approach (4). Results The patient sample’s mean age was 63 years (range 48–75). Patients underwent video-assisted thoracoscopic surgery (VATS) with intent to cure. The majority (79 %) had comorbidities, including chronic obstructive pulmonary disease (26 %), cardiovascular disease (26 %) and hypertension (26%). Pre-illness physical activity levels of the patients showed that 47 % had not met the national recommendation for physical activity. Patients started exercising 15 days following surgery (median) (range 14–41 days). Delay was due to postoperative complications (pain, pneumothorax, pneumonia, atrial fibrillation, general discomfort). Eight participants dropped out of the intervention. Reasons for non-adherence included chemotherapy side effects (nausea, fatigue) (n=3), other reasons (n=1), fractured arm (n=1), work (n=1), terminally ill husband (n=1) and death (n=1). The mean attendance rate for the 11 participants who completed the intervention was 82 % (range 58–100 %). No patients experienced severe adverse events (e.g. heart- or respiration stop) during or following exercise. The interview findings are organized into three themes reflecting the timespan related to the patients’ treatment trajectory: 1) Pre-intervention motivation for participation; 2) Benefits and barriers of the intervention; 3) Overall experiences with the intervention. Motivation for participation included patients’ expectations of physical benefits and the security of having professionals present. Patients experienced physical and emotional benefits and affirmed their social identity, including improved breathing and increased well-being and energy level. Group training had social benefits and the patients experienced a sense of belonging. Exercising with others in a similar circumstance was meaningful to the patients and created a sense of community. Barriers were primarily related to side-effects of chemotherapy. The intervention put the patients on track to a healthier lifestyle regarding physical activity and smoking, and regaining vitality and energy increased the participants’ faith in the future. The patients were satisfied with the exercise intensity level, contents and variation and felt that after 12 weeks of two 60-min weekly sessions they had regained a good amount of strength and energy. Two of the eight patients who were undertaking adjuvant chemotherapy started training on completion of their treatment, while three other patients exercised while being treated. Discussion To our knowledge, this is the first study that addresses operable NSCLC patient perspectives on participating in an exercise intervention during the immediate post-surgical period and subsequent chemotherapy. The sample of the 19 patients included in the interview study appears to be a select group of operable lung cancer patients. So far it has not been possible to compare the interview sample with the larger sample of the trial and therefore not possible to discuss representativeness of the selected sample. However, when comparing the interview study sample with other operable lung cancer patients, it appears that the study patients are a little younger, better educated, have early stage disease, good performance status and are used to physical activity. Although this sample is comparable with other lung cancer exercise samples (5), this suggests social inequality related to the intervention’s design. This might also explain why the operable lung cancer patients consented to participate in the intervention and changed their behaviour—a finding that is not comparable with the general lung cancer population reported to have particularly low levels of physical activity during the post-treatment period (6) and with patients engaged in light physical activity (7). Despite the fact that the studied sample might be a select group, the diagnosis appears to represent “a teachable moment” as discussed by Demark-Wahnefried and colleagues (8), and the intervention seem to assist the patients by increasing their physical function and energy, their well-being and improve their social capital. Eleven of the patients completed the intervention with a mean attendance rate of 82 %, which is comparable with other exercise intervention studies (9). This result underscores the patients’ desire and ability to complete the intervention. Reasons for dropping out of the intervention were due to external conditions unrelated to the intervention or due to chemotherapy side effects. Conclusion This study contributes to the literature by taking into account patient perspectives of exercise interventions. The supervised intervention was undertaken safely by operable lung cancer patients initiated 2 weeks after surgery. This select group of lung cancer patients experienced physical and emotional benefits and affirmed their social identity. This qualitative study indicates that exercise is beneficial for lung cancer patients in the postsurgical trajectory and especially for those who were physically active and motivated pre-illness. References 1. Adamsen L, Quist M,Andersen C, Moller T, Herrstedt J, Kronborg D et al (2009) Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ 339:b3410 2. Mishra SI, Scherer RW, Snyder C, Geigle PM, Berlanstein DR, Topaloglu O (2012) Exercise interventions on health-related quality of life for people with cancer during active treatment. Clin Otolaryngol 37(5):390–392 3. Sommer MS, Trier K, Vibe-Petersen J, Missel M, Christensen M, Larsen KR et al (2014) Perioperative rehabilitation in operation for lung cancer (PROLUCA)—rationale and design. BMC Cancer 14:404-2407–14-404 4. Ricoeur P (1976) Interpretation Theory. Discource and the surplus of meaning. TCU Press, Texas 5. Jones LW, Eves ND, Spasojevic I,Wang F, Il'yasova D (2011) Effects of aerobic training on oxidative status in postsurgical non-small cell lung cancer patients: a pilot study. Lung Cancer 72(1):45–51 6. Coups EJ, Park BJ, Feinstein MB, Steingart RM, Egleston BL, Wilson DJ et al (2009) Physical activity among lung cancer survivors: changes across the cancer trajectory and associations with quality of life. Cancer Epidemiol Biomarkers Prev 18(2):664–672 7. Lin YY,Wu YC, RauKM, Lin CC (2013) Effects of physical activity on the quality of life in Taiwanese lung cancer patients receiving active treatment or off treatment. Cancer Nurs 36(4):E35–E41 8. Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM (2005) Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. J Clin Oncol 23(24):5814–5830 9. Kjaer TK, Johansen C, Ibfelt E, Christensen J, Rottmann N, Hoybye MT et al (2011) Impact of symptom burden on health related quality of life of cancer survivors in a Danish cancer rehabilitation program: a longitudinal study. Acta Oncol 50(2):223–232

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      MS19.05 - Ethical Challenges in Conducting Clinical Research in Lung Cancer (ID 1935)

      15:12 - 15:25  |  Author(s): A.M. Tod, P. Allmark

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      Abstract:
      Background This paper will reflect upon some of the ethical challenges in conducting clinical research into lung cancer and mesothelioma. Lung cancer care, treatment and research operate in a complex environment. Characteristics of lung cancer that contribute to this complexity are that, in comparison to other cancer sites, it has a limited evidence base, high mortality, late presentation, diagnosis at advanced stage, few curative treatments, complex trial designs and nihilistic attitudes regarding treatment and research. As a result, people delay reporting lung cancer symptoms because of fear, fatalism and poor knowledge of treatment.[1] Such beliefs and attitudes may also influence decisions or prevent people from participating in research. When they are asked to participate, they are often in a situation of advanced illness with fear and/or fatalism in their minds. As such, they may be desperate volunteers.[ 2] Desperate Volunteers An example of a study involving desperate volunteers might be a surgical intervention for mesothelioma, such as the procedures in Mesothelioma And Radical Surgery (MARS)Trial[3] study or the new feasibility study of MARS 2. Treatment options in lung cancer and mesothelioma are increasing, but remain limited, especially regarding curative treatment. In mesothelioma, surgery will not be curative, but might be seen as the only palliative treatment that can make a substantial inroad into the disease pogression. Research treatments may therefore be seen as “the only treatment in town”. Both the multidisciplinary team and the patient may not see any other viable treatment. If the intervention is only available within research then research emerges as the only option. So what are the ethical challenges here? The ethical principle of voluntariness comes into play. Might recruitment into a trial be experienced as coercive – even if this is not the intention of the person recruiting? Is the experience of being approached about trial participation seen as coercive, or is it a decision in difficult circumstances? We need to ensure it is the later. It may be a decision taken under pressure, but needs to be made in a voluntary capacity. Other factors that will impact on levels of desperation, and the balance between coercion or decision, include whether the intervention is available outside the trial or not, and the trial design i.e. does it involve randomisation. Both these things will impact on someone’s readiness to participate in research and whether they will seek treatment outside of a trial. Finally it is necessary to consider whether the level of distress or desperation is impacting upon mental capacity.[4] Trials for all As previously stated, the evidence base for lung cancer is limited when compared to other cancer sites. There is also a drive in the UK cancer and health research community to ensure all patients have a right to access any appropriate trial. In the historical context of lung cancer being the “poor relation” in terms of research activity, caution is required to avoid being over-zealous in putting this right. People have the right to have access to appropriate trials but this does not mean every patient should be on a trial. There are many reasons why people will not want to embark on the journey of being a research participant. This should be respected. There is a theoretical argument that an over-zealous “trails for all” approach could have two other impacts. First, it may lead a desperate volunteer to misinterpret or inflate what the trial may offer in terms of treatment, cure or symptom impact; second it may change perceptions of equipoise. Equipoise Clinical equipoise provides the ethical basis and justification for medical research which involves assigning or randomising patients to different treatment arms of a trial. The term was first used by Benjamin Freedman in 1987.[5] If clinical equipoise exists there is genuine uncertainty over whether a treatment will be beneficial. It follows that it is reasonable for a clinician in equipoise to assign a patient to one arm or the other of a randomised trial. The challenge lies in deciding whether equipoise exists and whose interpretation it is based upon. Usually the decision is made according to the best evidence.[6] An ethical window of opportunity will exist within which it is justified to conduct a randomised trial. That is until evidence is generated to demonstrate whether an intervention is better than standard treatment or not. However, there is a value-based element to equipoise. As such equipoise may vary between researcher, clinician, and patient – and between different patients. For example, on the basis of best evidence it may be justified to randomise between a surgical intervention and standard care, as clinical equipoise is seen to exist. However, if standard treatment is NO treatment, will the patient view equipoise in the same way as the scientist? Implications The above challenges will apply in different ways to different patients and contexts. However This paper focuses on some key messages for clinical and research practice. These can be summarised as: · Information and consent: The process of providing participants with sufficient information, and obtaining informed consent, need to be actively managed in these complex situations. Sufficient time needs to be allowed in times of heightened emotion and a cooling off period is recommended in between information and consent. Also, consent should be approached in a staged or continuous manner, where willingness to continue participation in research is verified at different stages in the study. [· ]Research designs: Where possible, patient preference trial designs should be considered.[7,8] · Availability of research intervention outside of the trial: Consider the impact of this at the design stage. Is an agreement possible to cease delivery outside of a trial until evidence is generated? · Equipoise: Whose equipoise is the trial based on? It is necessary to consider patient/participant values as well as the judgements of the scientist and clinician. · Patient experience: It is worth including a qualitative component in trials to understand what is going on for the participants, and trial staff, in terms of decisions to participate and be randomised, response to allocation, and experience of intervention. 1. Tod AM. Allmark P. Craven J. Diagnostic delay in lung cancer: a qualitative study. Journal of Advanced Nursing. 2008. 61(3), 336-343 2. Allmark P (2006) Should desperate volunteers be included in randomised controlled trials? JMedEth 32, 548-53 3. Treasure T, et al. Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol. 2011 Aug;12(8):763-72. doi: 10.1016/S1470-2045(11)70149-8. Epub 2011 Jun 30. 4. Mental Capacity Act Code of Practice (2005) online Chapter 11 5. Freedman B (1987) Equipoise and the ethics of clinical research NEJM 317(3), 141-5 6. Kurzrock J, Stewart D (2014) Equipoise abandoned? Randomization and clinical trials. Ann Onc 24(10), 2471-74 7. Ismalia A, Walter S 2014 Review of designs for accommodating patients' or physicians' preferences in randomized controlled trials. In Montfort K van. et al Developments in Statistical Evaluation of Clinical Trials Sedgwick P (2013) What is a patient preference trial? BMJ 347:f5970

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      MS19.06 - The Lung Cancer Patient - Addressing Issues of Survivorship (ID 1936)

      15:25 - 15:38  |  Author(s): M. Guerin

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      Abstract:
      An individual is considered a cancer survivor from the time of diagnosis, through the balance of his or her life (NCSI –Survivorship definitions 2004) . In the UK Lung cancer survival has improved over the past two decades .In 1990 17% of male and female lung cancer patients were alive after one year compared with 29% of men and 33% of women diagnosed with lung cancer in 2010 . (The National Cancer Intelligence Network – public health England 2013).Such noticeable improvement in survival rates illustrates the improvements in Lung cancer care from diagnostics, treatments and configuration of cancer services. However variations and gaps in the delivery of lung cancer care nationally and internationally reinforce concerns around survivorship care. Lung cancer is a diagnosis associated with heavy disease burden and survivors may experience a myriad of concerns related to diagnosis and or treatment with high levels of physical and psychological distress affecting the quality of life for both patients and carer’s. Maguire et al (2012) reported that many people with a lung cancer diagnosis feel that supportive care needs are not being met, they have significantly more unmet supportive care needs compared to other cancer types. They are also less aware of supportive care elements available and have limited information to resources. (Steele and Fitch, 2008) The American Cancer Society (ACS)’s has set one of its 2015 goals for the nation as establishing “..Measurable improvement in the quality of life from the time of diagnosis and for the balance of life for all cancer survivors” Recent years have seen the growth of a new trends in medicine that are based entirely on data obtained from patients own assessment of their symptoms and ability to function “normally” Widely known in the cancer fields as a self-evaluation of health status or outcomes assessment. Such assessments were directed primarily towards patient evaluation and came to be known as health-related quality of life (HRQOL) in order to distinguish it from the quality of life of the general population. HRQOL refers to multidimensional assessments that include physical, psychological, social domains and also include other domains such as cognitive functioning, sexuality and spirituality. While single areas such as performance status or symptoms may be components of HRQOL they are, by themselves, insufficient to constitute a complete HRQOL assessment. In addition, the assessment of HRQOL does not usually include some other patient reported assessments, such as needs assessment and satisfaction with care. Thus, patient-reported outcomes (PROs) a more inclusive term, was proposed to include any data that may be reported directly by the patient without an intermediary such as a family member or a healthcare professional (Willke et al. 2004). The process of obtaining PRO data is commonly referred to as PRO measurement (PROM)s (Osoba 2011) The National cancer survivorship Initiative, (NCSI) launched in 2007, initially had limited evidence around the needs of cancer survivors. Taking action to improve outcomes (NCSI 2013)collected information on quality of life (QoL) through the use of PROMS and identified that many cancer survivors had unmet needs. Following on from the success of this National Cancer Survivorship Initiative, The Living With and Beyond Cancer (LWBC) Programme was set up in June 2014. This two year partnership between NHS England and Macmillan Cancer Support is aimed at entrenching NCSI findings and recommendations ensuring that those living with and beyond cancer get the care and support they require to lead as healthy and active a life as possible, for as long as possible. There are a number of key recommendations, including the introduction of an integrated package of interventions, “The Recovery Package”, which includes • Structured Holistic Needs Assessment and Care Planning, • Treatment Summaries and Cancer Care reviews • Patient education and support events (Health and Wellbeing Clinic) • Advice about and access to schemes that support people to undertake physical activity and healthy weight management. The collaboration of multi-disciplinary working involved in such interventions will enable improved outcomes for cancer survivors, through creating a shared understanding between patient and professionals about the issues important to the individual patient, identifying any needs to be addressed in an appropriate and timely manner. It has been designed to complement the stratified care pathway (NHS Improvement 2012) which enables individualised follow-up care as a supported self-management programme, shared care or complex care. REFRENCES National Cancer Institute –Survivorship definitions 2004 The National Cancer Intelligence Network – public health England 2013) One-year survival for lung cancers diagnosed in England 1990-2010 Maguire,R. et al. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501 Steele R, Fitch MI. Why patients with lung cancer do not want help with some needs. Support 2008 Mar;16(3):251-9. The American Cancer Society 2015 Organisational outcomes Willke, R.J., Burke, L.B. and Erickson, P. (2004) Measuring treatment impact: a review of patient reported outcomes and other efficacy endpoints in approved product labels. Control Clinical Trials 25: 535_552. Osoba,D. Health-related quality of life and cancer clinical trials Advance Medical Oncology (2011) 3(2) 57_71 The National cancer survivorship Initiative Living with and beyond cancer: Taking action to improve outcomes (2013) The Recovery Package, National Cancer Survivorship Initiative, NHS Improvement 2012 Innovation to implementation: Stratified pathways of care for people living with or beyond cancer- NHS Improvement 2012

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    P1.11 - Poster Session/ Palliative and Supportive Care (ID 229)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      P1.11-005 - Enhancing Evaluation of Cancer Cachexia in Patients with NSCLC by Assessing Change in Skeletal Muscle Mass at the L1 Level on Routine Chest CT (ID 2761)

      09:30 - 09:30  |  Author(s): P. Hollen

      • Abstract
      • Slides

      Background:
      Cancer cachexia (CC) and sarcopenia occur in up to 60% of patients with lung cancer. With better knowledge of the pathophysiology leading to cancer cachexia, multiple recent therapeutic trials have been directed at these mechanisms. Additionally, it is clear that cancer cachexia is associated with several negative outcomes. Inherent in all studies for this problem, is the ability to measure components of cancer cachexia, such as skeletal muscle mass (SMM). SMM assessment by CT scanning (SD <1.2kgs) is more accurate than either Dual X ray absorptiometry (DXA, SD 3kgs) or than bioelectrical impedance (SD 9.3kgs). A single slice on CT at the third lumbar vertebra (L3) correlates highly (r=0.924) with total body SMM in healthy individuals. While CT measurement at L3 is often used in cancer cachexia trials, the problem exists that routine chest CT scans rarely extend to L3; thus routine chest CTs will not allow inclusion of most patients. Importantly, prior studies in normal subjects demonstrated high correlation (r = 0.903) of SMM measurement at L1 with L3; however, the utility and feasibility of L1 measurement of SMM has not been assessed in patients with cancer.

      Methods:
      We enlisted patients with NSCLC and performed SMM measurements at L1 using Slice-O-Matic software for muscle mass in the Hounsfield unit range of -29 to +150. Patients were assessed for accuracy of using the L1 level for imaging quality and the ability to use the software properly.

      Results:
      56 patients with NSCLC (99 CT assessments) were enlisted at three institutions. Characteristics: 45% female; medians: age 60, KPS 80%; BMI 24.96, weight 72.38 kg, SMM index 58.89. Sarcopenia was detected in 29% of patients (58% of males <55.5 cm2/M2; 6% of females <38.5cm2/M2) with all having normal or overweight BMI. Overall, of the 99 CT images, 92.9% (95% CI = 88%-98%) included L1. 5 additional images (5%) were difficult to evaluate for SMM due to ascites or effusions; also, 1 patient was too obese for proper imaging; 2 had poor quality scans. Importantly, inclusion of L1 differed among the 3 institutions ranging from 80.6% to 97.2%. Also noted, as previously reported with assessment at L3 (r = 0.35), the correlation of BMI with SMM in this study at L1 was low (r = 0.36) as well.

      Conclusion:
      This study indicates that: 1) SMM assessment at L1 is achievable on routine chest CT in patients with lung cancer, with 93% of patients having images at this level, and 93% have acceptable quality for SMM evaluation; 2) although L1 is included in the majority of patients at all 3 institutions, this may vary by different radiologic protocols; 3) the low correlation and poor sensitivity of BMI to identify muscle mass loss is equally demonstrated at both L3 and L1, and 4) use of L1 enhances patient evaluation for SMM without needing additional testing or radiation exposure, and allows many more patients with NSCLC to have assessment of SMM in clinical trials and patient management. Funding in part: NIH/NCI 1 R01 CA157409-01A1

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-040 - Prospective Evaluation of Changes in Cancer Cachexia in NSCLC in Patients given Chemotherapy by Correlating Skeletal Muscle Mass with PRO Results (ID 2845)

      09:30 - 09:30  |  Author(s): P. Hollen

      • Abstract
      • Slides

      Background:
      Cancer cachexia and sarcopenia are common in lung cancer, and are associated with poor outcomes. Several recent interventional trials in cancer cachexia in patients with lung cancer have endeavored to improve skeletal muscle mass (measured by skeletal muscle mass index – SMI - using DXA or CT) and to correlate changes with functional outcomes of benefit to the patient. While functional tests such as stair climb power and hand grip strength have been used, these measures are neither sufficiently sensitive in patients with cancer, nor do they evaluate outcomes demonstrated to be valuable to patients. Patient Reported Outcomes (PROs) such as EORTC, FACT and others, have been collected, but specific components useful to patients have not been identified as ones correlating highly with SMI. Recent large studies at baseline using the 3-Item Global Index (3IGI) of the Lung Cancer Symptoms Scale (LCSS) quality of life and functional measure found strong correlations predicting survival in non-small cell lung cancer (N = 602) and in mesothelioma (N = 444); thus the 3IGI appears to be a good factor for associating PROs with SMI changes (Symanowski ASCO 2014; Gralla ASCO 2014). Additionally, over 90% of patients with NSCLC have expressed that parameters such as activity level and quality of life (included in the 3IGI) are of great importance to them.

      Methods:
      The LCSS was measured every 3 weeks in patients with a minimum KPS = 60 who were receiving chemotherapy. Correlations of SMI changes with 3IGI scores were made at baseline (at the time of initiation of chemotherapy) and at a median of 14 weeks in patients with Stage IIIB or IV NSCLC. SMI was measured by CT (Slice-O-Matic software) at the L1 vertebral level. A change in SMI by ± 4% was considered a threshold change of importance.

      Results:
      We have analyzed 24 patients to date (50% female; medians: age 57, KPS 80%; baseline: BMI 24.3, SMI 59.9, with 38% of males < 55.4 SMI). 19 patients are evaluable at this time. 42% of patients had a change in SMI by ± 4%; of these 75% had either improvement or worsening of the 3IGI in the direction expected from the change in SMI (improved 3IGI with increased SMI; worsened 3IGI with decreased SMI). No clear relationship in SMI was observed with response to chemotherapy thus far in the analysis.

      Conclusion:
      These results suggest: 1) the 3IGI may be useful in identifying both positive and negative changes in SMI, when using a 4% threshold change; 2) while we continue to enlist patients in this study, a confirmatory larger evaluation should be conducted; and 3) no measure should be used in practice or clinical trials of cancer cachexia or sarcopenia unless it has demonstrated validity in patients with cancer.

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