Table 1 Operationalization of the outcomes and measurement points shown by outcomes
Outcome | Measure | t1 | t2 | t3 |
|---|---|---|---|---|
Primary outcome: Psychosocial care through specialized services | ||||
Inpatient psycho-oncological service | Operation and procedure codes in the clinic information system or self-developed questionnaire | x | ||
Cancer Counseling Center | Self-developed questionnaire | x | ||
Inpatient social service | Operation and procedure codes in the clinic information system or self-developed questionnaire | x | ||
Outpatient psychotherapy | Self-developed questionnaire | x | ||
Neuropsychology | Medical records or operation and procedure codes in the clinic information system | x | ||
Rehabilitation | Self-developed questionnaire or data derived from medical records | x | ||
Secondary outcomes | ||||
Percentage of patients that can be assessed for psychosocial distress | Participation rate in intervention arm vs control arm | x | ||
Length of doctor–patient consultation | In minutes (documentation by clinicians in the study worksheet) | x | ||
Emotional functioning/distress | EORTC QLQ-C30, emotional functioning scale | x | x | |
Health-related quality of life | EORTC QLQ-C30, global scale and BN20, all scales | x | x | |
Support requested | Self-developed questionnaire | x | x | x |
Appointments arranged in specialized services | Documentation by clinicians in the study worksheet | x | ||
Direct costs of support | Calculated on the basis of the patient–doctor consultation duration | x | ||
Accuracy of the screening method | Comparison of the screening results regarding unmet needs (intervention vs control arm) with a detailed diagnosis based on SCID interview | x | ||
Evaluation of protocol adherence | Questions to patients: whether they have completed a DT (control arm) or whether the doctor has inquired about their psychosocial condition (intervention arm) | x | ||