Barbara Moore

Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial

PURPOSE Venous thromboembolism (VTE) is common in cancer patients. Evidence has suggested that low molecular weight heparin (LMWH) might improve survival in patients with cancer by preventing both VTE and the progression of metastases. No trial in a single cancer type has been powered to demonstrate a clinically significant survival difference. The aim of this trial was to investigate this question in patients with lung cancer. PATIENTS AND METHODS We conducted a multicenter, open-label, randomized trial to evaluate the addition of a primary prophylactic dose of LMWH for 24 weeks to standard treatment in patients with newly diagnosed lung cancer of any stage and histology. The primary outcome was 1-year survival. Secondary outcomes included metastasis-free survival, VTE-free survival, toxicity, and quality of life. RESULTS For this trial, 2,202 patients were randomly assigned to the two treatment arms over 4 years. The trial did not reach its intended number of events for the primary analysis (2,047 deaths), and data were analyzed after 2,013 deaths after discussion with the independent data monitoring committee. There was no evidence of a difference in overall or metastasis-free survival between the two arms (hazard ratio [HR], 1.01; 95% CI, 0.93 to 1.10; P = .814; and HR, 0.99; 95% CI, 0.91 to 1.08; P = .864, respectively). There was a reduction in the risk of VTE from 9.7% to 5.5% (HR, 0.57; 95% CI, 0.42 to 0.79; P = .001) in the LMWH arm and no difference in major bleeding events but evidence of an increase in the composite of major and clinically relevant nonmajor bleeding in the LMWH arm. CONCLUSION LMWH did not improve overall survival in the patients with lung cancer in this trial. A significant reduction in VTE is associated with an increase in clinically relevant nonmajor bleeding. Strategies to target those at greatest risk of VTE are warranted.

“I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial

BackgroundFew studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such trials are needed to enable a broader evaluation of patient experiences in the trial, with important ethical and practical implications for the design and conduct of similar trials and treatment regimes in the future.MethodsTen participants were recruited from the control and intervention arms of FRAGMATIC: a non-placebo trial for patients with advanced lung cancer. Participants were interviewed at up to three time points during their time in the trial. Interviews were analysed using Interpretive Phenomenological Analysis.ResultsPatients were motivated to join the trial out of hope of medical benefit and altruism. Understanding of randomisation was mixed and in some cases poor, as was appreciation of trial purpose and equipoise. The trial was acceptable to and evaluated positively by most participants; participants receiving the intervention focused on the potential treatment benefits they hoped they would receive, whilst participants in the control arm found alternative reasons, such as altruism, personal fulfilment and positive attention, to commit to and perceive benefits from the trial. However, whilst experiences were generally very positive, poor understanding, limited engagement with trial information and focus on treatment benefits amongst some participants give cause for concern.ConclusionsBy exploring longitudinally the psychological, emotional and cognitive domains of trial participation, we consider potential harms and benefits of participation in non-placebo trials amongst patients with advanced lung cancer and identify several implications for future research with and care for patients with advanced cancer.Trial registrationISRCTN80812769. Registered on 8 July 2005.

Managing, making sense of and finding meaning in advanced illness: a qualitative exploration of the coping and wellbeing experiences of patients with lung cancer

Abstract Coping plays an essential role in maintaining the wellbeing of patients with cancer. A number of different coping responses and strategies have been identified in the literature. The value and relevance of meaning based coping theory has also been emphasised, including Antonovoskys Sense of Coherence (SoC) theory. Ten patients with advanced lung cancer were interviewed up to three times. A total of twenty in depth interviews were carried out, fully transcribed and data were analysed following a methodology of Interpretative Phenomenological Analysis. Three broad domains were identified to categorise the core life concerns of participants; making sense of and managing ones illness; maintaining daily life and relationships and confronting the future. Within these domains multiple coping themes are identified, which to varying degrees help to maintain patient wellbeing and quality of life. This article considers the relevance of SoC theory for understanding the coping experiences of patients with advanced cancer, and identifies resources and factors likely to support patient coping, with implications for health and social care services.

“ Hitting the spot ”: Developing individuals with lived-experience of health and social care as facilitators to deliver a course to enhance public involvement in research – a Welsh perspective

Plain English summaryPublic involvement in research has become an important and integral part of the research process in health and social care, from the early stages of research prioritisation and development to the later stages of research conduct and dissemination.Learning and development opportunities, including training, can assist the public and researchers in working together in the research process, and a training schedule exists in Wales for this purpose. One of the key components of this training schedule in Wales is the course Involving the Public in the Design and Conduct of Research: Building Research Partnerships. Building on the existing successes of this UK-wide course, first developed by Macmillan Cancer Support, a project was established between Health and Care Research Wales and Macmillan Cancer Support to develop three members of the Involving People Network into trained facilitators. Once trained, the aim was for the three facilitators to deliver the course in Wales.Macmillan Cancer Support and Health and Care Research Wales selected, through a competitive process, three members of the Involving People Network to use their lived experience of Involvement in research projects, as well as any lived experience of a physical or mental health condition or illness, to become facilitators of the course in the unique context of public involvement in research in Wales.Through this process many benefits were realised, including developing the course content and its delivery in Wales, as well as building the skills and confidence of the individuals themselves as facilitators. This has contributed to a continuing commitment to the sustainable delivery of the Involving the Public in the Design and Conduct of Research: Building Research Partnerships course in Wales and a combined approach to addressing any challenges and obstacles which presented.AbstractHealth and Care Research Wales has a strategic aim to Ensure public involvement and engagement is central to what we do and visible in all elements of it. As part of the ongoing development of the Health and Care Research Wales Training Programme a project was initiated to develop members of the public as facilitators to deliver a public involvement in research course.The project was undertaken in collaboration with Macmillan Cancer Support and was advertised via the Involving People Network in Wales. Three trainee facilitators were recruited, from 14 people that applied, to deliver a public involvement in research training course, the Building Research Partnerships course, as it was known then, originally developed for and by Macmillan Cancer Support.As members of the Involving People Network, the trainees were given training, mentorship, financial and administrative support to develop their role as facilitators over a two year period. This has been reciprocated with incredible commitment, ongoing course delivery in Wales, excellent course evaluations, course review and involvement in future planning.Through this project several benefits were realised, including developing the course content and its delivery and building the skills and confidence of the individual facilitators themselves. Additionally, and importantly, the project team found that patients and members of the public who are given appropriate training and support can greatly enhance a research training programme and act as highly effective ambassadors to further the cause of public involvement in research.

Raising awareness of research in palliative care – the roadshow!

Aim To ensure all specialist palliative care teams are aware of research development and research recruitment opportunities and thus maximise access to palliative care research for all patients in Wales. Method The Marie Curie Palliative Care Research Centre, Cardiff, collaborated with the Wales Cancer Research Network and NISCHR Cancer Research Group to plan a series of roadshows with palliative care teams across Wales. Initially, a Pilot roadshow was launched at the All Wales Palliative Care Conference, Gregynog in October 2010. This tested, by peer review, the format and content of the series of roadshows planned for 2011. The pilot received constructive feedback and changes were made to ensure the roadshow content was clear and relevant to its intended audience. The roadshows took place at locations selected by the local clinical lead, at lunchtimes, and lasted 1–2 h. The panel of speakers took the audience through a research project from idea to completion, using a real life example. The audience completed feedback forms. Outcome Feedback was overwhelmingly positive. Several clinicians have contacted the group with their research ideas. Staff have been introduced to their NISCHR Regional Research Nurse Manager. Contact details have been collected and a palliative care database established.