Clinical Studies

Multicentric, KSSG as main centre

Zentrum für Integrative Medizin, Neurologie, Medizinische Onkologie und Hämatologie

Automatically Closed

2012

2014

Krebsliga Switzerland

Background - Rationale In patients with advanced, incurable, symptomatic cancer the two criteria tumour-control and toxicity are considered as insufficient to alone guide individual decisions for chemotherapy in palliative intention (CPI). The additional criteria symptom control and physical function are often used, conceptualized for some tumours as patient-centred clinical benefit criteria. However, clinical trials investigating these criteria as primary endpoints are rare, the validity of clinical trials having Best Supportive Care control arms to inform decisions is weak, and extrapolation from tumour response to symptom benefit is often unreliable. Further individual and contextual criteria may influence decision processes for CPI, such as patient‘s (remaining) life goals, symptom control before CPI, logistic factors (e.g., time schedule, access to clinic), or costs. In addition to the criteria for CPI itself, there are known factors that influence in general health care decisions (F-HCD), such as age, significant other, family status, culture, life expectancy, or decision-making preferences. There is a lack of available, context-relevant, and measurable decision criteria for CPI. Research questions 1. Which set of decision criteria for CPI is considered as important by physicians, patients or nurses? 2. Which decision criteria for CPI are applied in ―real world‖ oncology clinics or home doctors‘ offices? Aims and specific aims 1. To systematically identify CPI-decision criteria considered as important by experienced, communication competent physicians, patients, and nurses when considering CPI in a ―multidisciplinary, integrated oncology & palliative care‖ or a ―home doctor (GP) office experienced with advanced cancer patients‖ setting. 2. To investigate the use of CPI-decision criteria in cancer clinics and GP offices when considering CPI, 2.1. to assess the level of agreement between patient and physician for present use of decision criteria, 2.2. to assess which decision criteria were judged as important or not by patients and by physicians, 2.3. to compare patient characteristics, based on CPI-decision criteria and F-HCD, in patients with high versus low agreement with the physician for presence and importance of decision criteria. Exploratory aims 1. To explore the experience of patients and physicians 1-2 months after applying CPI-decision criteria. First, a systematic literature review (SLR) investigates current evidence of decision criteria in advanced cancer care. As 2nd step physicians (oncologists and GP‘s), patients, and nurses, recruited upon inclusion criteria, perform a formal Delphi process (focus groups to collect potential factors [considering also results of the SLR], narrow down by the study team [including international experts], decide through voting) to make the decision criteria set for CPI. As 3rd step immediately after a decision was made in a physician-patient visit regarding a CPI, physician and patients independently complete the decision criteria set for CPI (yes/no), and quantify the importance of each decision criteria

- Amy Abernethy, Dukes Cancer Center, USA - Eduardo Bruera, MD Anderson Cancer Center, USA - Thomas Smith, Virgina Cancer Center, USA - Martin Tattersall, Sydney Cancer Center, Australia - Yousuf Zafar, Dukes Cancer Center, USA - Dr. Peter Frey, Institut für Hausarztmedizin, Universität Bern - Christian Häuptle, General Practitioner, Gossau - SAKK (Swiss Group of Clinical Cancer Research - Dieter Köberle, Cantonal Hospital, St.Gallen - Roger von Moos, Cantonal Hospital, Chur - Daniel Betticher, Cantonal Hospital, Freiburg