Clinical trial NCT02988635: Early Palliative Care on Quality of Life of Advanced Cancer Patients
Official title: Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Gastric Cancer
Pancreatic Cancer
Biliary Tract Cancer
Keywords: Early Palliative Care
Simultaneous Care
Chemotherapy
Quality of Life
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
Collaborators: name: Regione Emilia-Romagna
First posted: 2016-12-09
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.

Detailed description: The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.

Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.

Exclusion Criteria:

* Patients already receiving care from the PC service or pretreated with chemotherapy ± biological

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Survival
timeFrame: from date of randomization until date of death or for a minimum of six months
measure: Resource utilization at the end of life (EOL): chemotherapy utilization
timeFrame: From date of randomization until death or for a minimum of six months after enrollment
measure: Resource utilization at the end of life (EOL): hospital admissions
timeFrame: From date of randomization until death or for a minimum of six months after enrollment
measure: Resource utilization at the end of life (EOL): emergency room admissions
timeFrame: From date of randomization until death or for a minimum of six months after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
name: VITTORIO FRANCIOSI, M.D.
role: PRINCIPAL_INVESTIGATOR
References: