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Table 1 Primary, secondary, and explorative objectives, and related endpoints and assessments

From: PALLiON – PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care

  Objectives Endpoint Assessment method
Primary To compare use of chemotherapy in the last 3 months of life in the control and intervention groups Proportion of patients who receive chemotherapy at EoL Numerical and descriptive data from HCP registrations/e-CRF, last 3 months before death
Secondary To examine the administration of chemotherapy last 3 months, medical interventions/treatments at EoL, after discontinuation of chemotherapy Number of chemotherapy cycles, initiation, and discontinuation
Proportion of patients who receive other medical interventions, i.e. concomitant medication and artificial nutrition
Numerical and descriptive data from HCP registrations/e-CRF, last 3 months of life, and after discontinuation of chemotherapy
To compare PROs Patient-reported symptom burden, QoL, anxiety/depression, satisfaction with information EAPC basic dataset. EORTC-QLQ PAL15, PHQ-9, GAD-7, EORTC QLQ-INFO25
To compare caregiver-reported outcomes Caregiver-reported health, QoL, and satisfaction with care SF-36, FAMCARE
Explorative To examine length of survival Length of survival from start of last line of chemotherapy HCP registrations, Cause of Death Registry
To examine direct costs Costs of healthcare, oncology/palliative units Length of stay, number of hospitalizations, anticancer and other medical interventions
  1. e-CRF electronic case report form, EoL end-of-life, HCP healthcare provider, PRO patient-reported outcome, QoL quality of life