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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma, Esophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Functional Assessment of Cancer Therapy (Quality of life measure)

Outcome Time Frame:

baseline and 12 weeks

Safety Issue:

No

Principal Investigator

Jennifer Temel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

10-434

NCT ID:

NCT01401907

Start Date:

May 2011

Completion Date:

April 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Mesothelioma
  • Esophageal Cancer
  • Gastric Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Palliative care
  • Lung
  • Gastric
  • Liver
  • Pancreatic
  • Esophageal
  • Caregiver
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Mesothelioma
  • Pancreatic Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617