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Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective Anticoagulation Length with low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT): study protocol for a mixed-methods study

Authors: Joanna D Smith, Jessica Baillie, Trevor Baglin, Gareth O Griffiths, Angela Casbard, David Cohen, David A Fitzmaurice, Kerenza Hood, Peter Rose, Alexander T Cohen, Miriam Johnson, Anthony Maraveyas, John Bell, Harold Toone, Annmarie Nelson, Simon I Noble

Published in: Trials | Issue 1/2014

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Abstract

Background

Venous thromboembolism is common in patients with cancer and requires anticoagulation with low molecular weight heparin. Current data informs anticoagulation as far as six months, yet guidelines recommend anticoagulation beyond six months in patients who have locally advanced or metastatic cancer. This recommendation, based on expert consensus, has not been evaluated in a clinical study. ALICAT (Anticoagulation Length in Cancer Associated Thrombosis) is a feasibility study to identify the most clinically and cost effective length of anticoagulation with low molecular weight heparin in the treatment of cancer associated thrombosis.

Methods/Design

ALICAT is a randomized multi-centre phase two mixed-methods study with three components: a randomized controlled trial, embedded qualitative study and a survey investigating pathways of care. The randomized controlled trial will compare ongoing low molecular weight heparin treatment for cancer-associated thrombosis versus cessation of low molecular weight heparin at six months treatment (current licensed practice) in patients with locally advanced or metastatic cancer. The embedded qualitative study will include focus groups with clinicians to investigate attitudes to recruiting to the study, identify the challenges of progressing to a full randomized controlled trial, and also semi-structured interviews with patients and relatives/carers to explore their attitudes towards participating in the study and potential barriers and concerns to participation. Finally, a UK wide survey exercise will be undertaken to develop a classification and enumeration system for the cancer associated thrombosis models and pathways of care.

Discussion

There is a lack of evidence determining the length of anticoagulation for patients with cancer associated thrombosis and subsequently treatment length varies. The ALICAT study will consider the feasibility of recruiting patients to a phase three trial.

Trial registration

Current Controlled Trials ISRCTN37913976.
Appendix
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Literature
1.
Silverstein M, Heit J, Mohr D, Petterson T, O’Fallon W, Melton LI: Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med. 1998, 158: 585-593. 10.1001/archinte.158.6.585.CrossRefPubMed
2.
3.
Department of Health: Report of the Independent Expert Working Group on the Prevention of Venous Thromboembolism in Hospitalised Patients. 2007, London: Department of Health
4.
Noble S, Pasi J: Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer. 2010, 102: 2-9.CrossRef
5.
Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C: British Committee for Standards in Hematology: Guidelines of oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011, 154: 311-324. 10.1111/j.1365-2141.2011.08753.x.CrossRefPubMed
6.
Noble S, Shelley M, Coles B, Williams S, Wilcock A, Johnson M: Management of venous thromboembolism in patients with advanced cancer: a systematic review and meta-analysis. Lancet Oncol. 2008, 9: 577-584. 10.1016/S1470-2045(08)70149-9.CrossRefPubMed
7.
Levitan N, Dowlati A, Remick S, Tahsildar H, Sivinski L, Beyth R, Rimm A: Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine (Baltimore). 1999, 78: 285-291. 10.1097/00005792-199909000-00001.CrossRef
8.
Sorensen H, Mellemkjaer L, Olsen J, Baron J: Prognosis of cancers associated with venous thromboembolism. New England Med J. 2000, 343: 1846-1850. 10.1056/NEJM200012213432504.CrossRef
9.
Noble S: The challenges of managing cancer related venous thromboembolism in the palliative care setting. Postgrad Med J. 2007, 83: 671-674. 10.1136/pgmj.2007.061622.CrossRefPubMedPubMedCentral
10.
Noble S, Finlay I: Is long-term low-molecular-weight heparin acceptable to palliative care patients in the treatment of cancer associated thromboembolism? A qualitative study. Palliat Med. 2005, 19: 197-201. 10.1191/0269216305pm1008oa.CrossRefPubMed
11.
Hull R, Pineo G, Brant R, Mah A, Burke N, Dear R, Wong T, Cook R, Solymoss S, Poon M, Raskob G, LITE Trial Investigators: Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med. 2006, 119: 1062-1072. 10.1016/j.amjmed.2006.02.022.CrossRefPubMed
12.
Lee A, Levine M, Baker R, Bowden C, Kakkar A, Prins M, Rickles F, Julian J, Haley S, Kovacs M, Gent M, CLOT Investigators: Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. New England Med J. 2003, 349: 146-153. 10.1056/NEJMoa025313.CrossRef
13.
Meyer G, Marjanovic Z, Valcke J, Lorcerie B, Gruel Y, Solal-Celigny P, Le Maignan C, Extra J, Cottu P, Farge D: Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med. 2002, 162: 1729-1735. 10.1001/archinte.162.15.1729.CrossRefPubMed
14.
Kearon C, Kahn S, Agnelli G, Goldhaber S, Roskob G, Comerota A, Physicians ACoC: Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008, 133: 454-545. 10.1378/chest.08-0658.CrossRef
15.
Khorana A, Streiff M, Farage D, Mandala M, Debourdeau P, Cajifinger F, Marty M, Falanga A, Lyman G: Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. J Clin Oncol. 2009, 27: 4919-4926. 10.1200/JCO.2009.22.3214.CrossRefPubMedPubMedCentral
16.
Farge D, Debourdeau P, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Bounameaux H, Büller HR: International clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer. J Thromb Haemost. 2013, 11: 56-70. 10.1111/jth.12070.CrossRefPubMed
17.
Blom JW, Doggen CJ, Osanto S, Rosendaal FR: Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005, 293: 715-722. 10.1001/jama.293.6.715.CrossRefPubMed
18.
Johnson MJ, Sproule MW, Paul J: The prevalence and associated variables of deep venous thrombosis in patients with advanced cancer. Clin Oncol (R Coll Radiol). 1999, 11: 105-110. 10.1053/clon.1999.9023.CrossRef
19.
Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH: Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007, 110: 2339-2346. 10.1002/cncr.23062.CrossRefPubMed
20.
Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A: Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002, 100: 3484-3488. 10.1182/blood-2002-01-0108.CrossRefPubMed
21.
Johnson MJ: Problems of anticoagulation within a palliative care setting: an audit of hospice patients taking warfarin. Palliat Med. 1997, 11: 306-312. 10.1177/026921639701100407.CrossRefPubMed
22.
Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR, American College of Chest Physicians: Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based Clinical Practice Guidelines. Chest. 2012, 141: e419S-e494S.CrossRefPubMedPubMedCentral
23.
Noble S, Hood K, Finlay I: The use of long-term low-molecular weight heparin for the treatment of venous thromboembolism in palliative care patients with advanced cancer: a case series of sixty two patients. Palliat Med. 2007, 21: 473-475. 10.1177/0269216307080816.CrossRefPubMed
24.
Kakkar A, Kessler C, Goldhaber S, Kovacs M, Spyropolous A, Ortel T, Pabinger I, Huisman M, Bergqvist D, Monreal M, Turpie AG, Francis CW: Dalteparin sodium for the long-term management of venous thromboembolism in cancer patients. The DALTECAN study. J Thromb Haemost. 2013, 11: 74-
25.
26.
27.
Cosmi B, Legnani C, Iorio A, Pengo V, Ghirarduzzi A, Testa S, Poli D, Tripodi A, Palareti G, PROLONG Investigators (on behalf of FCSE IFoAC): Residual venous obstruction, alone and in combination with D-dimer, as a risk factor for recurrence after anticoagulation withdrawal following a first idiopathic deep vein thrombosis in the prolong study. Eur J Vasc Endovasc Surg. 2010, 39: 356-365. 10.1016/j.ejvs.2009.11.022.CrossRefPubMed
28.
Tan M, Mos I, Klok F, Huisman M: Residual venous thrombosis as predictive factor for recurrent venous thromboembolim in patients with proximal deep vein thrombosis: a systematic review. Br J Haematol. 2011, 153: 168-178. 10.1111/j.1365-2141.2011.08578.x.CrossRefPubMed
29.
30.
Krueger R, Casey M: Focus Groups: A Practical Guide for Applied Research. 2000, Thousand Oaks, California: Sage, 3
31.
Edwards A, Sivell S, Dundon J, Elwyn G, Evans R, Gaff C, Iredale R, Shaw C, Thornton H, Gray J, Clarke E: Effective risk communication in clinical genetics: a systematic review. Report to: Department of Health; Genetics Research Programme – Health Services Research (Grant HSR03A; ISBN 0-9550975-2-5). Cardiff Centre for Health Sciences Research. 2006, Cardiff UK: Cardiff University
32.
Patton M: Qualitative Research and Evaluation Methods. 2002, Thousand Oaks, California: Sage Publications
33.
Lewin S, Glenton C, Oxman A: Use of qualitative methods alongside randomized controlled trials of complex healthcare interventions: methodological study. Br Med J. 2009, 339: 3496-10.1136/bmj.b3496.CrossRef
34.
Beanlands H, Horsburgh M, Fox S, Howe A, Locking-Cusolito H, Pare K, Thrasher C: Caregiving by family and friends of adults receiving dialysis. Nephrol Nurs J. 2005, 32: 621-631.PubMed
35.
Creswell J: Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. 2003, Thousand Oaks, California: Sage Publications
36.
Gillham B: The Research Interview. 2000, New York: Continuum
37.
Hussainy S, Marriott J: Recruitment strategies for palliative cancer care patients and carers. Int J Pharm Pract. 2009, 17: 369-371. 10.1211/ijpp.17.06.0009.CrossRef
38.
Ritchie J, Spencer L: Qualitative data analysis for applied policy research. Analyzing Qualitative Data. Edited by: Bryman A, Burgess R. 1994, London: Routledge
39.
Aaronson N, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez N, Filiberti A, Flechtner H, Fleishman S, de Haes J, Kaasa S, Klee MC, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw KCA, Sullivan M, Takeda F: The European Organisation for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993, 85: 365-376. 10.1093/jnci/85.5.365.CrossRefPubMed
40.
Herman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011, 20: 1727-1736. 10.1007/s11136-011-9903-x.CrossRef
41.
42.
Bruera E, Kuehn N, Miller M, Selmser P, Macmillan K: The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991, 7: 6-9.PubMed
43.
Watanabe S, Nekolaichuk C, Beaumont C, Johnson L, Myers J, Strasser F: A multicenter study comparing two numerical versions of the Edmonton Symptom Assessment System in palliative care patients. J Pain Symptom Manage. 2011, 41: 456-468. 10.1016/j.jpainsymman.2010.04.020.CrossRefPubMed
44.
45.
46.
Metadata
Title
A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective Anticoagulation Length with low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT): study protocol for a mixed-methods study
Authors
Joanna D Smith
Jessica Baillie
Trevor Baglin
Gareth O Griffiths
Angela Casbard
David Cohen
David A Fitzmaurice
Kerenza Hood
Peter Rose
Alexander T Cohen
Miriam Johnson
Anthony Maraveyas
John Bell
Harold Toone
Annmarie Nelson
Simon I Noble
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-122

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