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Early Palliative Care on Quality of Life of Advanced Cancer Patients

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ClinicalTrials.gov Identifier: NCT02988635
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
Regione Emilia-Romagna
Information provided by (Responsible Party):
Vittorio Franciosi, Azienda Ospedaliero-Universitaria di Parma

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Gastric Cancer Pancreatic Cancer Biliary Tract Cancer Other: Early Palliative Care Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Effects of Early Palliative Care on Quality of Life of Advanced Cancer Patients. A Multicenter Controlled Randomised Clinical Trial
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Early Palliative Care
Subjects receive standard of care with early palliative care.
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.

No Intervention: Standard of Care
Subjects receive standard of care.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Survival [ Time Frame: from date of randomization until date of death or for a minimum of six months ]
  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988635


Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Regione Emilia-Romagna
Investigators
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Principal Investigator: VITTORIO FRANCIOSI, M.D. UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY

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Responsible Party: Vittorio Franciosi, M.D., Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT02988635     History of Changes
Other Study ID Numbers: RERSCE35E13
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vittorio Franciosi, Azienda Ospedaliero-Universitaria di Parma:
Early Palliative Care
Simultaneous Care
Chemotherapy
Quality of Life

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Biliary Tract Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases