Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Enrollment
- 281
- Primary Endpoint
- Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Vittorio Franciosi
M.D.
Azienda Ospedaliero-Universitaria di Parma
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
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
Time Frame: Change from baseline to 12 weeks
compare change in QOL from baseline to 12 weeks between study arms
Secondary Outcomes
- 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)
- 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)
- 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)