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A.M. Tod
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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: 1
- Moderators:P. Hollen, B. Ivimey
- Coordinates: 9/08/2015, 14:15 - 15:45, 708+710+712
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MS19.05 - Ethical Challenges in Conducting Clinical Research in Lung Cancer (ID 1935)
14:15 - 15:45 | Author(s): A.M. Tod
- Abstract
- Presentation
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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ORAL 43 - Enhancing Physical Wellbeing in Lung Cancer (ID 168)
- Event: WCLC 2015
- Type: Oral Session
- Track: Nursing and Allied Professionals
- Presentations: 1
- Moderators:G. Bates, M. Hesdorffer
- Coordinates: 9/09/2015, 18:30 - 20:00, 102+104+106
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ORAL43.02 - Which Patients Are Assessed by a Lung Cancer Nurse Specialist: A UK National Lung Cancer Audit Study (ID 1258)
18:30 - 20:00 | Author(s): A.M. Tod
- Abstract
- Presentation
Background:
Lung cancer nurse specialists (LCNS) are an integral part of the multidisciplinary team, supporting, managing and coordinating of care for people with lung cancer. In the UK the National Institute of Health and Care Excellence (NICE) recommends that all patients have access to a LCNS in a trust, but recent National Lung Cancer Audit (NLCA) reports show that LCNS access varies across England. The aim of this study was to examine how access to a LCNS varies by patient and National Health Service (NHS) trust characteristics.
Methods:
We used data on all lung cancer patients in the NLCA first presenting to 150 English NHS trusts between January 1[st] 2007 and December 31[st] 2011. NHS trusts are health care organisations typically 1-3 hospitals collectively covering regional catchment populations. The NLCA collects key clinical information, including LCNS assessment on all individuals with a diagnosis of lung cancer presenting to NHS trusts. Data from 146/150 trusts were successfully linked with the National Cancer Action Team (NCAT) census of the LCNS workforce (number, salary grades) for 2011. Multinomial logistic regression was used to calculate the likelihood of being assessed by a LCNS by patients clinical and LCNS workforce at each trust.
Results:
Across 146 NHS trusts there were128,124 patients and 321 LCNSs. LCNS assessment records showed80,113 (62%) patients were assessed, 7,544 (6%) were not assessed, and 40,467 (32%) had missing information on assessment. Missing assessment information was random and not biased to certain types of patients or trust and data completeness increased over the years. Patients (>75 years old), those with poor performance status (i.e. PS 4) and those with comorbidities were less likely to be assessed (adjusted relative risk ratios (RRR) (95% confidence interval) 0.84 (0.75 – 0.93), 0.34 (0.24 – 0.47) & 0.71 (0.63 – 0.79) respectively). There was no difference in assessment rates by socioeconomic groups. Patients who received anti-cancer treatment (surgery, chemotherapy with radiotherapy or chemotherapy alone) were over twice likely to have been assessed by a LCNS compared with those who did not receive treatment 2.09 (1.75 – 2.50), 3.96 (3.11 – 5.04) & 3.45(2.71 – 4.38). Annual LCNS patient caseload did not appear to impact access, but there was an association between assessment and a higher salary grade of the LCNS workforce in a trust (RRR 1.59 (0.86 – 2.92) for trusts with LCNS salary band 7 & 8).
Conclusion:
We found variations in access to LCNSs by both patient and trust a feature, which indicates an unmet need for people with lung cancer in England. To meet the needs of all people with lung cancer and the clear targets set out by NICE, we need to expand the current LCNS workforce and ensure that we retain experienced nurses as LCNS are an integral part of the lung cancer team and provide help to people with lung cancer.
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P2.06 - Poster Session/ Screening and Early Detection (ID 219)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.06-005 - Lung Cancer Risk Perception: Findings from the PAIRS-COPD Study (ID 821)
09:30 - 17:00 | Author(s): A.M. Tod
- Abstract
Background:
Detecting new or early lung cancer symptoms in people who have COPD is especially difficult as early signs of disease may be masked by existing chronic respiratory symptoms. Public awareness of lung cancer symptoms remains low despite recent media campaigns. A lack of knowledge and understanding of their condition and associated risks may account for patient symptom reporting delay. Over 60% of UK lung cancer patients are diagnosed at a stage where curative treatment is no longer an option. Early reporting and diagnosis can provide curative treatment options and improved outcomes. New, cost effective interventions that promote timely detection and diagnosis and that are acceptable to patients are required. Prospective Assessment of Incident Respiratory Symptoms (PAIRS-COPD) is a feasibility study that evaluated four-monthly telephone reviews of COPD patient’s respiratory symptoms, by a primary care nurse. This abstract presents findings that identify the intervention’s effectiveness in prompting symptom reporting and referral and explores participant’s perceptions of their chest condition and lung cancer risk.
Methods:
Mixed methods were used. Quantitative analysis of frequency of identification of indications for a chest X-ray was undertaken with COPD patients on a primary care register (n=77). A purposive sample (n=12) were selected for semi-structured telephone interviews (7 women and 5 men) to evaluate patient perceptions and experiences and acceptability of the intervention. Interviews were audio taped and transcribed. Thematic analysis was used.
Results:
Interviewees revealed that living with respiratory symptoms for protracted periods resulted in a high level of symptom tolerance. New symptoms were assumed to be an inevitable and expected part of their normal illness trajectory or of aging more generally. Awareness of prognostic implications and lung cancer risk was low. The interviewees reported the belief that decline was inevitable. This, combined with their worsening respiratory condition and high symptom tolerance, had made delay in reporting new or deteriorating symptoms inevitable. However, as a consequence of the intervention, symptoms recommended to prompt a chest X-ray by the National Institute of Clinical Excellence (NICE) were identified in 27% of the 77 volunteers over the 12-month study period. In 5%, criteria for an urgent lung cancer referral were met. Importantly, the interviewees described how the intervention was acceptable and accessible as it did not require additional travel and visits to the doctor. It successfully provided them with a more nuanced understanding of their chest condition, increased knowledge of early indicators of acute exacerbation and enhanced their self-management skills. The calls also heightened interviewees’ appreciation of their increased risk of lung cancer and awareness of the associated symptoms. They reported adopting more proactive help seeking behaviours.
Conclusion:
This study reveals how the PAIRS-COPD intervention can help COPD patients identify and report new symptoms that may otherwise be accepted or missed. In the study symptoms requiring further investigation and referral were uncovered surprisingly frequently. For a client group with a significant symptom burden, the lack of disruption was a primary reason for the acceptability of the intervention.
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P2.09 - Poster Session/ Nursing and Allied Professionals (ID 227)
- Event: WCLC 2015
- Type: Poster
- Track: Nursing and Allied Professionals
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.09-003 - Identifying Research Questions in Disclosure of Risk of Recurrence following Lung Cancer Surgery Using a Critical Synthesis of the Literature (ID 280)
09:30 - 17:00 | Author(s): A.M. Tod
- Abstract
Background:
Although surgery for lung cancer is often a successful treatment, very little is known about how patients cope and live with the possibility of recurrence of cancer in the future. Two published literature reviews on prognosis disclosure in cancer care have identified no papers focused specifically on risk of recurrence in post-surgical lung cancer patients. Aims were to develop a synthesis of the current literature around prognostic disclosure in cancer care in order to: · Identify a thematic framework that can be used to provide a model for the factors present in prognostic disclosure in cancer care. · Identify research questions that will inform future study into disclosure of recurrence risk in lung cancer patients following potentially curative surgery.
Methods:
A review of published studies on prognostic disclosure in cancer care up until the end of 2003 was used as a starting point. An updated review was undertaken and a systematic approach was taken to searching the literature from 2004 – June 2014. Data were extracted from the identified papers using a comprehensive data extraction form. Codes were assigned to key elements of data within the results and conclusion sections of the papers. Critical interpretive synthesis was used to explore themes by constructing an integrative grid to examine findings between studies and to identify similarities and contradictions. Themes from the original review were identified and compared to the updated findings. A further framework grid was constructed to investigate between-theme relationships and to help identify “synthetic constructs” and a thematic framework.
Results:
Twenty papers were identified in the updated review and were diverse in their objectives and patient groups. Themes were identified in these studies and in the original review covering the nature of prognostic information, patient need for prognostic information, patient need to maintain hope, balancing hope and realism, patient factors, disease factors and clinician factors. A thematic framework was developed. Future research questions were framed around disclosure of risk of recurrence following lung cancer surgery.
Conclusion:
There are no studies looking at prognostic information-giving in post-surgical lung cancer patients. Patients generally want prognostic information, but also want information that supports hope. Patients appear to struggle to fully understand complex prognostic information and value help making sense of information. Working with patients to understand and manage the uncertainty of their situation may be particularly valuable. Future research questions include: · How do patients and their clinical teams manage information disclosure about possible cancer recurrence following lung cancer surgery? · What is the emotional impact on patients of the uncertainty of potential recurrence following lung cancer surgery? · What information do patients want regarding recurrence risk? · What strategies do patients and professionals currently use to help manage the uncertainty of potential recurrence after lung cancer surgery? · Are there strategies or interventions aimed at managing uncertainty in this group that could have wider application for patients?
