Early Palliative Care on Quality of Life of Advanced Cancer Patients

Azienda Ospedaliero-Universitaria di Parma

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer; Biliary Tract Cancer; Non-small Cell Lung Cancer; Pancreatic Cancer

Treatments: Other: Early Palliative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02988635

RERSCE35E13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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281 participants in 2 patient groups

Early Palliative Care

Experimental group

Description:

Subjects receive standard of care with early palliative care.

Treatment:

Other: Early Palliative Care

Standard of Care

No Intervention group

Description:

Subjects receive standard of care.