Early Palliative Care on Quality of Life of Advanced Cancer Patients

Phase 3

Completed

• Conditions: Pancreatic Cancer; Gastric Cancer; Non-small Cell Lung Cancer; Biliary Tract Cancer
• Interventions: Other: Early Palliative Care

• Registration Number: NCT02988635
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Study First Posted: 2016-12-09
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Palliative Care	Early Palliative Care	Subjects receive standard of care with early palliative care.

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)	Change from baseline to 12 weeks	compare change in QOL from baseline to 12 weeks between study arms

Secondary Outcome Measures

Name	Time	Method
Survival	from date of randomization until date of death or for a minimum of six months
Resource utilization at the end of life (EOL): chemotherapy utilization	From date of randomization until death or for a minimum of six months after enrollment	percentage of patients who died, that in the 30 days preceding the death received chemotherapy
Resource utilization at the end of life (EOL): hospital admissions	From date of randomization until death or for a minimum of six months after enrollment	percentage of patients who died, that in the 30 days preceding the death were admitted to hospital
Resource utilization at the end of life (EOL): emergency room admissions	From date of randomization until death or for a minimum of six months after enrollment	percentage of patients who died, that in the 30 days preceding the death went to the emergency room