The systematic early integration of palliative care into multidisciplinary oncology care in the hospital setting (IPAC), a randomized controlled trial: the study protocol

Gaëlle Vanbutsele, Simon Van Belle, Martine De Laat, Veerle Surmont, Karen Geboes, Kim Eecloo, Koen Pardon, Luc Deliens, Gaëlle Vanbutsele, Simon Van Belle, Martine De Laat, Veerle Surmont, Karen Geboes, Kim Eecloo, Koen Pardon, Luc Deliens

Abstract

Background: Previous studies in the US and Canada, have shown the positive impact of early palliative care programs for advanced cancer patients on quality of life (QoL) and even survival time. There has been a lack of similar research in Europe. In order to generalize the findings from the US and Canada research on a larger scale, similar studies are needed in different countries with different care settings. The aim of this paper is to describe the research protocol of a randomized controlled trial, situated in Flanders, Belgium, evaluating the effect of systematic early integration of palliative care in standard oncology care.

Methods/design: A randomized controlled trial will be conducted as follows: 182 patients with advanced cancer will be recruited from the departments of Medical Oncology, Digestive Oncology and Thoracic Oncology of the Ghent University Hospital. The trial will randomize patients to either systematic early integration of palliative care in standard oncology care or standard oncology care alone. Patients and informal caregivers will be asked to fill out questionnaires on QoL, mood, illness understanding and satisfaction with care at baseline, 12 weeks and every six weeks thereafter. Other outcome measures are end-of-life care decisions and overall survival time.

Discussion: This trial will be the first randomized controlled trial in the Belgian health care setting to evaluate the effect of systematic early integration of palliative care for advanced cancer patients. The results will enable us to evaluate whether systematic early integration of palliative care has positive effects on QoL, mood and patient illness-understanding and which components of the intervention contribute to these effects.

Trial registration: Clinicaltrials.gov Identifier: NCT01865396 , registered 24(th) of May, 2013.

References

    1. Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, et al. Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012;30:1980–8. doi: 10.1200/JCO.2011.39.2381.
    1. Greaves J, Glare P, Kristjanson LJ, Stockler M, Tattersall MHN. Undertreatment of nausea and other symptoms in hospitalized cancer patients. Support Care Cancer. 2009;17:461–4. doi: 10.1007/s00520-008-0511-4.
    1. Hearn J, Higginson IJ. Outcome measures in palliative care for advanced cancer patients: a review. J Public Health Med. 1997;19:193–9. doi: 10.1093/oxfordjournals.pubmed.a024608.
    1. Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med [Internet] 2010;363(8):733–42. doi: 10.1056/NEJMoa1000678.
    1. Bauman JR, Temel JS. The Integration of Early Palliative Care With Oncology Care: The Time Has Come for a New Tradition. J Natl Compr Cancer Netw. 2014;12(12):1763–71.
    1. Bakitas M, Lyons K, Hegel M. The Project ENABLE II Randomized Controlled Trial to Improve Palliative Care for Patients with Advanced Cancer. J Am Med Assoc. 2009;302(7):741–9. doi: 10.1001/jama.2009.1198.
    1. Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;18:1721–30. doi: 10.1016/S0140-6736(13)62416-2.
    1. Zimmermann C. Effectiveness of Specialized Palliative Care : A systematic review. J Am Med Assoc. 2014;299(14):1698-1709.
    1. Temel JS, Greer J, Admane S, Gallagher ER, Jackson V, Lynch TJ, et al. Longitudinalperceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: Results of a randomized studyof early palliative care. J Clin Oncol. 2011;29(17):2319–26.
    1. Pirl WF, Greer JA, Traeger L, Jackson V, Lennes IT, Gallagher ER, et al. Depression and survival in metastatic non-small-cell lung cancer: effects of early palliative care. J Clin Oncol [Internet] 2012;30:1310–5. doi: 10.1200/JCO.2011.38.3166.
    1. Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012;30(4):394–400. doi: 10.1200/JCO.2011.35.7996.
    1. Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, et al. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol. 2012;30(8):880–7. doi: 10.1200/JCO.2011.38.5161.
    1. Zorg FEP. Evaluatierapport palliatieve zorg. 2014.
    1. Beernaert K, Cohen J, Deliens L, Devroey D, Vanthomme K, Pardon K, et al. Referral to palliative care in COPD and other chronic diseases: a population-based study. Respir Med Elsevier Ltd. 2013;107(11):1731–9. doi: 10.1016/j.rmed.2013.06.003.
    1. Nichol AD, Bailey M, Cooper DJ. Challenging issues in randomised controlled trials. Injury. 2010;41(Suppl 1):S20–3. doi: 10.1016/j.injury.2010.03.033.
    1. Bruera E, Kuehn N, Miller MJ, 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.
    1. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization 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;85:365–76. doi: 10.1093/jnci/85.5.365.
    1. Cohen SR, Mount BM, Bruera E, Provost M, Rowe J, Tong K. Validity of the McGill Quality of Life Questionnaire in the palliative care setting: a multi-centre Canadian study demonstrating the importance of the existential domain. Palliat Med. 1997;11:3–20. doi: 10.1177/026921639701100102.
    1. Robin Cohen S, Mount BM. Living with cancer: “Good” days and “Bad” days - What produces them? Can the McGill Quality of Life Questionnaire distinguish between them? Cancer. 2000;89:1854–65. doi: 10.1002/1097-0142(20001015)89:8<1854::AID-CNCR28>;2-3.
    1. Albers G, Echteld MA, de Vet HCW, Onwuteaka-Philipsen BD, van der Linden MHM, Deliens L. Evaluation of quality-of-life measures for use in palliative care: a systematic review. Palliat Med. 2010;24:17–37. doi: 10.1177/0269216309346593.
    1. Katon WJ, Simon G, Russo J, Von Korff M, Lin EHB, Ludman E, et al. Quality of depression care in a population-based sample of patients with diabetes and major depression. Med Care. 2004;42:1222–9. doi: 10.1097/00005650-200412000-00009.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27:363–70. doi: 10.1017/S0033291796004382.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–13. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305:160–4. doi: 10.1136/bmj.305.6846.160.
    1. Kristjanson LJ. Validity and reliability testing of the famcare scale: Measuring family satisfaction with advanced cancer care. Soc Sci Med. 1993;36:693–701. doi: 10.1016/0277-9536(93)90066-D.
    1. Chambaere K, Bilsen J, Cohen J, Onwuteaka-Philipsen BD, Mortier F, Deliens L. Physician-assisted deaths under the euthanasia law in Belgium: a population-based survey. CMAJ. 2010;182:895–901. doi: 10.1503/cmaj.091876.
    1. Chambaere K, Bilsen J, Cohen J, Onwuteaka-Philipsen BD, Mortier F, Deliens L. Trends in medical end-of-life decision making in Flanders, Belgium 1998-2001-2007. Med Decis Making. 2011;31:500–10. doi: 10.1177/0272989X10392379.
    1. Bainbridge D, Seow H, Sussman J, Pond G, Martelli-Reid L, Herbert C, et al. Multidisciplinary health care professionals’ perceptions of the use and utility of a symptom assessment system for oncology patients. J Oncol Pract. 2011;7(c):19–23. doi: 10.1200/JOP.2010.000015.
    1. Yoong J, Park ER, Greer JA, Gallagher ER JVA, Pirl WF. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013;173(4):283–90. doi: 10.1001/jamainternmed.2013.1874.
    1. Jacobsen J, Jackson V, Dahlin C, Greer J, Perez-Cruz P, Billings JA. Components of early outpatient palliative care consultation in patients with metastatic nonsmall cell lung cancer. J Palliat Med. 2011;14(4):459–64. doi: 10.1089/jpm.2010.0382.
    1. Back AL, Park ER, Greer JA, Jackson VA, Jacobsen JC, Gallagher ER, et al. Clinician Roles in Early Integrated Palliative Care for Patients with Advanced Cancer. J Palliat Med. 2014;17(11):1244–8. doi: 10.1089/jpm.2014.0146.
    1. Deshields T, Zebrack B, Kennedy V. The state of psychosocial services in cancer care in the United States. Psychooncology. 2013;22(February 2012):699–703. doi: 10.1002/pon.3057.
    1. Fayers P, Bottomley A. Quality of life research within the EORTC—the EORTC QLQ-C30. Eur J Cancer. 2002;38:125–33. doi: 10.1016/S0959-8049(01)00448-8.
    1. Dalgaard KM, Bergenholtz H, Nielsen ME, Timm H. Early integration of palliative care in hospitals: A systematic review on methods, barriers, and outcome. Palliat Support Care. 2014;12:1–19.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir