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2014-11
2016-11
2016-11
281
NCT02988635
Azienda Ospedaliero-Universitaria di Parma
Azienda Ospedaliero-Universitaria di Parma
INTERVENTIONAL
Early Palliative Care on Quality of Life of Advanced Cancer Patients
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-12-04 | N/A | 2016-12-07 |
2016-12-07 | N/A | 2016-12-09 |
2016-12-09 | N/A | 2016-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Early Palliative Care Subjects receive standard of care with early palliative care. | OTHER: Early Palliative Care
|
| NO_INTERVENTION: Standard of Care Subjects receive standard of care. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
