Biliary Tract Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Pancreatic Cancer
Conditions
Keywords
Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life
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.
Interventions
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.
Sponsors
Regione Emilia-Romagna
Azienda Ospedaliero-Universitaria di Parma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed