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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

 ObjectivesEndpointAssessment method
PrimaryTo compare use of chemotherapy in the last 3 months of life in the control and intervention groupsProportion of patients who receive chemotherapy at EoLNumerical and descriptive data from HCP registrations/e-CRF, last 3 months before death
SecondaryTo examine the administration of chemotherapy last 3 months, medical interventions/treatments at EoL, after discontinuation of chemotherapyNumber 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 PROsPatient-reported symptom burden, QoL, anxiety/depression, satisfaction with informationEAPC basic dataset. EORTC-QLQ PAL15, PHQ-9, GAD-7, EORTC QLQ-INFO25
To compare caregiver-reported outcomesCaregiver-reported health, QoL, and satisfaction with careSF-36, FAMCARE
ExplorativeTo examine length of survivalLength of survival from start of last line of chemotherapyHCP registrations, Cause of Death Registry
To examine direct costsCosts of healthcare, oncology/palliative unitsLength 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