The PELICAN Study. Patient Experience of LIving with CANcer associated thrombosis
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1 The PELICAN Study Patient Experience of LIving with CANcer associated thrombosis Simon Noble: Clinical Reader in Palliative Medicine, Cardiff University & Honorary Consultant in Palliative Medicine, Aneurin Bevan Health Board. Hayley Prout: Research Associate, Annmarie Nelson: Deputy Director Marie Curie Palliative Care Research Centre, WCTU, Cardiff University John Bell & Jacqui McCarthy: Research Partners Wales Cancer Trials Unit, Cardiff University
2 Background Cancer associated thrombosis (CAT) is now recognised as a separate disease that should be managed differently to venous thromboembolism (VTE) in patients without cancer. Whilst the management of CAT is clearly well known, the effect of CAT on the patient s quality of life (QoL) is yet to be properly measured.
3 How CAT differs to VTE Most precipitants of VTE (e.g. surgery, immobility, acute illness) are transient and have passed by the time VTE has been treated. The presence of VTE in patients confers a poor prognosis when compared to similar stage cancer patients without VTE (Sorensen et al 2000). The symptoms attributable to VTE are similar to other cancer related conditions and as such, CAT may be under-diagnosed or diagnosed later than VTE in non-cancer patients (Noble 2007). Anticoagulation of CAT is associated with an increased risk of bleeding and a greater rate of thrombosis recurrence when compared to VTE in non-cancer patients (Prandoni et al 2002). The gold standard treatment for most patients with VTE remains warfarin after initial anticoagulation with low molecular weight heparin (LMWH) (Keeling et al 2011). However, it is recommended that patients with CAT should receive three to six months LMWH (Noble et al 2008). Although the evidence only supports LMWH for six months in the treatment of CAT, some cancer patients may require indefinite anticoagulation since the cancer, and thus the pro-thrombotic risk, remains.
4 Aim To evaluate the experiences of patients with CAT in the UK in order to have an understanding of the impact of CAT and to find ways to improve their QoL.
5 Objectives Are the current validated VTE QoL tools understandable and usable for patients? What do patients view as important about their condition? The impact of the treatment for CAT. How does CAT affect them emotionally? Additional support needed for patients.
6 Sample Royal Gwent Hospital, Newport (n=10) Velindre Cancer Centre, Cardiff (n=10) Inclusion Criteria: Patients with histologically confirmed cancer; Patients with radiologically confirmed VTE both DVT and PE; Patients receiving anticoagulation for at least eight weeks at the time of interview; Patients able to give informed consent; Patients able to communicate in English and take part in an interview; Patients age 16 and over.
7 Methods Interview consisting of two components: Semi-structured interview; Cognitive interview.
8 The semi-structured interview To explore the patient s understanding of their diagnosis and the impact this has on their quality of life. To consider the physical, psychological and social aspects of their lives.
9 The Cognitive Interview To test existing QoL questionnaires pertaining to pulmonary embolism (PE) and deep vein thrombosis (DVT) and to ascertain how relevant these documents are for use with patients with CAT.
10 Cognitive Interviewing Cognitive interviewing is based on cognitive psychology and can been used as a method for pre-testing questionnaires prior to their distribution (Drennan 2003). Using verbal probing, observation of participants behaviour and encouragement of respondents to think aloud, it can be used to understand human information processing (Drennan 2003).
11 The Cognitive Interview Participants will be asked to complete one or two QoL questionnaires relating to CVD measures depending on whether they have a DVT, a PE or both. Either: The PEmb-QoL questionnaire - measures QoL for patients with pulmonary embolisim (PE) (Cohn et al 2009); The VEINES_QOL/SYM questionnaire - measures QoL for patients with a deep vein thrombosis (DVT) (Kahn et al 2006).
12 Analysis Semi-structured interview Framework Analysis involves a systematic process of sifting, charting and sorting material according to key issues and themes Familiarization with data; Identifying a thematic framework; Indexing the data; Charting; Mapping and interpretation. (Richie and Spencer 1994 p. 177)
13 Analysis Cognitive Interviews Deductive analysis (Crabtree 1999): limited to fixed categories determined prior to data analysis such as the items on the questionnaires used for the Pelican Study. Inductive analysis (Boyatiz 1998): where themes emerge from the analysis. This will capture any comments that participants make spontaneously as well as those comments relating to general probes (use of thematic analysis).
14 References Boyatzis R. Transforming qualitative information: Thematic analysis and code development Thousand Oaks, California: Sage. Cohn DM, Nelis EA, Busweiler LA, Kaptein AA, Middeldorp S. Quality of life after pulmonary embolism: the development of the PEmb-QoL questionnaire. J Thromb Haemost. [Letter Research Support, Non-U.S. Govt] Jun;7(6): Crabtree, B: Doing qualitative research Newbury Park. CA: Sage. Drennan J. Cognitive interviewing: verbal data in the design and pretesting of questionnaires. Journal of Advanced Nursing. 42(1) Kahn SR, Lamping DL, Ducruet T, Arsenault L, Miron MJ, Roussin A, et al. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol. [Research Support, Non-U.S. Gov't Validation Studies] Oct;59(10): Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. [Practice Guideline Review] Aug;154(3):
15 References (cont) Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. [Comparative Study] Nov 15;100(10): Noble S. The challenges of managing cancer related venous thrombo-embolism in the palliative care setting. Postgraduate Medical Journal (985) Noble SI, Shelley MD, Coles B, Williams SM, Wilcock A, Johnson MJ. Management of venous thromboembolism in patients with advanced cancer: a systematic review and meta-analysis. Lancet Oncol. [Meta-AnalysisReview] Jun;9(6): Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, Burgess R, editors. Analyzing Qualitative Data. New York: Routledge; Sorensen HT, Mellemkjaer L, Olsen JH, Baron JA. Prognosis of cancers associated with venous thromboembolism. N Engl J Med. [Research Support, Non-U.S. Gov't] Dec 21;343(25):
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