Back to resultsEarly Palliative Care on Quality of Life of Advanced Cancer Patients
Primary Purpose
Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Early Palliative Care
Sponsored by
About this trial
This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Palliative Care
Standard of Care
Arm Description
Subjects receive standard of care with early palliative care.
Subjects receive standard of care.
Outcomes
Primary Outcome Measures
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
compare change in QOL from baseline to 12 weeks between study arms
Secondary Outcome Measures
Survival
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
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
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
Full Information
NCT ID
NCT02988635
First Posted
December 4, 2016
Last Updated
December 7, 2016
Sponsor
Azienda Ospedaliero-Universitaria di Parma
Collaborators
Regione Emilia-Romagna
1. Study Identification
Unique Protocol Identification Number
NCT02988635
Brief Title
Early Palliative Care on Quality of Life of Advanced Cancer Patients
Official Title
Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria di Parma
Collaborators
Regione Emilia-Romagna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Cancer, Biliary Tract Cancer
Keywords
Early Palliative Care, Simultaneous Care, Chemotherapy, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
281 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Palliative Care
Arm Type
Experimental
Arm Description
Subjects receive standard of care with early palliative care.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects receive standard of care.
Intervention Type
Other
Intervention Name(s)
Early Palliative Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
Description
compare change in QOL from baseline to 12 weeks between study arms
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Survival
Time Frame
from date of randomization until date of death or for a minimum of six months
Title
Resource utilization at the end of life (EOL): chemotherapy utilization
Description
percentage of patients who died, that in the 30 days preceding the death received chemotherapy
Time Frame
From date of randomization until death or for a minimum of six months after enrollment
Title
Resource utilization at the end of life (EOL): hospital admissions
Description
percentage of patients who died, that in the 30 days preceding the death were admitted to hospital
Time Frame
From date of randomization until death or for a minimum of six months after enrollment
Title
Resource utilization at the end of life (EOL): emergency room admissions
Description
percentage of patients who died, that in the 30 days preceding the death went to the emergency room
Time Frame
From date of randomization until death or for a minimum of six months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VITTORIO FRANCIOSI, M.D.
Organizational Affiliation
UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Palliative Care on Quality of Life of Advanced Cancer Patients
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