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Electronic monitoring of symptoms and syndromes associated with cancer methods of a randomized controlled trial SAKK 9506 E-MOSAIC.doc

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Electronic monitoring of symptoms and syndromes associated with cancer methods of a randomized controlled trial SAKK 9506 E-MOSAIC

Blumetal.BMCPalliativeCare2012,11:19 /1472-684X/11/19 STUDY PROTOCOL OpenAccess Electronicmonitoringofsymptomsand syndromesassociatedwithcancer:methodsofa randomizedcontrolledtrialSAKK95/06E-MOSAIC DavidBlum1,2,DieterKoeberle3,KarinRibi4,Shu-FangHsuSchmitz5,7,UrsUtiger6,DirkKlingbiel5 andFlorianStrasser1* Abstract Background:Inpatientswithadvanced,incurablecancer,anticancertreatmentmaybeusedtoalleviate cancer-relatedsymptoms,butmonitoringofthemindailypracticeisrarelydone.Weaimtotesttheeffectiveness ofareal-timesymptomandsyndromeassessmentusingtheE-MOSAICsoftwareinstalledinhandheldcomputer generatingalongitudinalmonitoringsheet(LoMoS)providedtotheoncologistsinaphaseIIIsetting. Methods:Inthisprospectivemulticentreclusterrandomizedphase-IIItrialpatientswithanyincurablesolidtumor andhavingdefinedcancerrelatedsymptoms,whoreceivenewoutpatientchemotherapyinpalliativeintention (expectedtumor-sizeresponserate≤20%)areeligible.Immediatelybeforetheweeklyvisittooncologists,all patientscompletewithnurseassistancetheE-MOSAICAssessment:EdmontonSymptomAssessmentScale,≤3 additionalsymptoms,estimatednutritionalintake,bodyweight,Karnofskyandmedicationsforpainandcachexia. ExperiencedoncologistswillberandomizedtoreceivetheLoMoSornot.Tominimizecontamination,LoMoSare removedfromthemedicalchartsaftervisits.Primaryendpointisthedifferenceinglobalqualityoflife(items29 30ofEORTC-QlQ-C30)betweenbaselineandlaststudyvisitatweek6,witha10pointbetween-armdifference consideredtobeclinicallyrelevant.20clusters(=oncologists)pertreatmentarmwith4–8patientseachareaimed fortoachieveasignificancelevelof5%andapowerof80%inamixedmodelapproach.Selectedco-variablesare includedinthemodelforadjustment.Secondaryendpointsincludepatient-perceivedpatient-physician communicationsymptomburdenovertime,andoncologists’symptommanagementperformance(predefined thresholdsofsymptomscomparedtooncologists’pharmacological,diagnosticorcounsellingactions[structured chartreview]). Discussion:Thistrialwillcontributetotheresearchquest