Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01401907
First received: July 20, 2011
Last updated: July 27, 2015
Last verified: June 2015
  Purpose

The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.


Condition Intervention Phase
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Mesothelioma
Esophageal Cancer
Gastric Cancer
Liver Cancer
Pancreatic Cancer
Other: early palliative care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy (Quality of life measure) [ Time Frame: change from baseline to 12 weeks ] [ Designated as safety issue: No ]
    compare change in QOL from baseline to 12 weeks between study arms


Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy (Quality of life measure) [ Time Frame: change from baseline over 24 weeks ] [ Designated as safety issue: No ]
    compare change in QOL over the 24 week study period between study arms

  • Hospital Anxiety and Depression Scale (Mood) [ Time Frame: baseline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    compare rates of depression and anxiety between study arms

  • Prognostic Understanding [ Time Frame: baseiline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    compare responses to items of questionnaire between study arms

  • Family Caregiver Quality of Life (SF-36) [ Time Frame: baseline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    compare family caregiver QOL between study arms

  • Family Caregiver Hospital Anxiety and Depression Scale (Mood) [ Time Frame: baseline,12 and 24 weeks ] [ Designated as safety issue: No ]
    compare family caregiver mood between study arms

  • Family Caregiver Prognostic Understanding [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    compare responses to items of questionnaire between study arms

  • Resource utilization at the end of life (EOL) [ Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment ] [ Designated as safety issue: No ]
    chemotherapy utilization at the EOL hospice utilization (enrollment rate and length of stay)

  • Health Care Costs [ Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment ] [ Designated as safety issue: No ]
  • Code Status Documentation [ Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment ] [ Designated as safety issue: No ]
    examine rates and timing of code status documenation

  • Coping (Brief Cope) [ Time Frame: baseline, 12 and 24 weeks ] [ Designated as safety issue: No ]
    compare coping between study arms

  • Family Caregiver Quality of Life (SF-36) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FACT-Lung [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Lung cancer specific QOL

  • FACT-hepatobiliary and FACT-espophageal [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    GI cancer specific QOL


Other Outcome Measures:
  • Additional resource utilization [ Time Frame: from date of randomization until date of death, assessed up to 3 years ] [ Designated as safety issue: No ]
    hospital admissions, hospice utilization emergency room admissions intensive care unit admissions resuscitation attempt

  • Survival [ Time Frame: from date of randomization until date of death, assessed up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: May 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Palliative Care
Subjects receive standard of care with early palliative care.
Other: early palliative care
patient assigned to the intervention will receive early palliative care along with standard oncology care.
No Intervention: Standard of Care
Subjects receives standard of care

Detailed Description:

Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group.

Subjects who are randomized to Standard Oncology Care 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. They will complete questionnaires at 12 weeks and 24 weeks after enrollment.

Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent
  • Informed of metastatic disease within the previous 8 weeks
  • No prior therapy for metastatic disease
  • Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter
  • Relative or friend of patient who will likely accompany the patient to clinic visits

Exclusion Criteria:

  • Significant psychiatric or other co-morbid disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401907

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jennifer Temel, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01401907     History of Changes
Other Study ID Numbers: 10-434
Study First Received: July 20, 2011
Last Updated: July 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Palliative care
Lung
Gastric
Liver
Pancreatic
Esophageal
Caregiver

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Lung Neoplasms
Mesothelioma
Pancreatic Neoplasms
Small Cell Lung Carcinoma
Adenoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Mesothelial
Pancreatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on July 30, 2015