Early Palliative Care on Quality of Life of Advanced Cancer Patients

Non-small Cell Lung Cancer Clinical Trial

Official title:

Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988635
• Other study ID #: RERSCE35E13
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2016
• Last updated: December 7, 2016
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Gastric Cancer
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Other:
• Early Palliative Care
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma	Regione Emilia-Romagna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Survival		from date of randomization until date of death or for a minimum of six months	No
Secondary	Resource utilization at the end of life (EOL): chemotherapy utilization	percentage of patients who died, that in the 30 days preceding the death received chemotherapy	From date of randomization until death or for a minimum of six months after enrollment	No
Secondary	Resource utilization at the end of life (EOL): hospital admissions	percentage of patients who died, that in the 30 days preceding the death were admitted to hospital	From date of randomization until death or for a minimum of six months after enrollment	No
Secondary	Resource utilization at the end of life (EOL): emergency room admissions	percentage of patients who died, that in the 30 days preceding the death went to the emergency room	From date of randomization until death or for a minimum of six months after enrollment	No