Early Palliative Care on Quality of Life of Advanced Cancer Patients
December 7, 2016 updated by: Vittorio Franciosi, Azienda Ospedaliero-Universitaria di Parma
Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Palliative Care
Subjects receive standard of care with 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.
|
|
No Intervention: Standard of Care
Subjects receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Assessment of Cancer Therapy-General (FACT-G) (Quality of life measure)
Time Frame: Change from baseline to 12 weeks
|
compare change in QOL from baseline to 12 weeks between study arms
|
Change from baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival
Time Frame: from date of randomization until date of death or for a minimum of six months
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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
|
From date of randomization until death or for a minimum of six months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: VITTORIO FRANCIOSI, M.D., UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
December 4, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 9, 2016
Study Record Updates
Last Update Posted (Estimate)
December 9, 2016
Last Update Submitted That Met QC Criteria
December 7, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RERSCE35E13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.