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Table 1 Operationalization of the outcomes and measurement points shown by outcomes

From: Glioma patients in outpatient care—optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial

OutcomeMeasuret1t2t3
Primary outcome: Psychosocial care through specialized services
 Inpatient psycho-oncological serviceOperation and procedure codes in the clinic information system or self-developed questionnaire  x
 Cancer Counseling CenterSelf-developed questionnaire  x
 Inpatient social serviceOperation and procedure codes in the clinic information system or self-developed questionnaire  x
 Outpatient psychotherapySelf-developed questionnaire  x
 NeuropsychologyMedical records or operation and procedure codes in the clinic information system  x
 RehabilitationSelf-developed questionnaire or data derived from medical records  x
Secondary outcomes
 Percentage of patients that can be assessed for psychosocial distressParticipation rate in intervention arm vs control arm x 
 Length of doctor–patient consultationIn minutes (documentation by clinicians in the study worksheet) x 
 Emotional functioning/distressEORTC QLQ-C30, emotional functioning scalex x
 Health-related quality of lifeEORTC QLQ-C30, global scale and BN20, all scalesx x
 Support requestedSelf-developed questionnairexxx
 Appointments arranged in specialized servicesDocumentation by clinicians in the study worksheet x 
 Direct costs of supportCalculated on the basis of the patient–doctor consultation duration  x
 Accuracy of the screening methodComparison of the screening results regarding unmet needs (intervention vs control arm) with a detailed diagnosis based on SCID interview x 
Evaluation of protocol adherenceQuestions to patients: whether they have completed a DT (control arm) or whether the doctor has inquired about their psychosocial condition (intervention arm) x 
  1. Abbreviations: EORTC QLQ-C30 European Organization of Research and Treatment of Cancer Quality of Life Core Questionnaire, BN20: brain-cancer-specific module, SCID Structured Clinical Interview for DSM, DT Distress Thermometer
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Trials

ISSN: 1745-6215