Early Palliative Care on Quality of Life of Advanced Cancer Patients

NCT02988635 | Completed Phase 3 DMC

• 1 other identifier: RERSCE35E13
• Study Type: interventional
• Target: 281
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Early Palliative Care; Simultaneous Care; Chemotherapy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)

  compare change in QOL from baseline to 12 weeks between study arms

  Change from baseline to 12 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Early Palliative Care

EXPERIMENTAL

Subjects receive standard of care with early palliative care.

Other: Early Palliative Care

Standard of Care

NO INTERVENTION

Subjects receive standard of care.

Interventions

Early Palliative Care OTHER

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.

Early Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• Regione Emilia-Romagna: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Pancreatic Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Study Officials

• VITTORIO FRANCIOSI, M.D.

  UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share