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Completed

NCT Number: NCT02988635

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.

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Key information

Conditions

Non-small Cell Lung Cancer Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early palliative care

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Collaborators

  • Regione Emilia-Romagna

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2016
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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