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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