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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: April 15, 2017
Last verified: April 2017
  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
Non-small Cell Lung Cancer Small Cell Lung Cancer Mesothelioma Esophageal Cancer Gastric Cancer Liver Cancer Pancreatic Cancer Other: early palliative care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
early palliative care
Masking: Single (Outcomes Assessor)
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 Jennifer Temel, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy (Quality of Life Measure) [ Time Frame: 12 weeks ]
    The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study


Secondary Outcome Measures:
  • Functional Assessment of Cancer Therapy (Quality of Life Measure) [ Time Frame: 24 weeks ]
    The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.

  • Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale [ Time Frame: Week-12 and Week-24 ]
    The hospital anxiety and depression scale examines symptoms of depression and anxiety. We report the depression subscale score here ranging from 0-21 with higher scores indicating higher depression symptoms. A cut off of 8 indicates clinically significant depression symptoms. We compared rates of clinically significant depression symptoms between study arms at week-12 and week-24.

  • Proportion of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer [ Time Frame: Week12 and Week 24 ]
    We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.

  • Family Caregiver Quality of Life as Measured by the SF-36 [ Time Frame: Week-12 and Week-24 ]
    The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.

  • Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) [ Time Frame: Week 12 and Week 24 ]
    We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms

  • Proportion of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer [ Time Frame: 12 and 24 weeks ]
    We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.

  • 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 ]
    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 ]
  • Code Status Documentation [ Time Frame: study participants will be followed until death or for a minimium of 2 years after enrollment ]
    examine rates and timing of code status documenation

  • Coping (Brief Cope) [ Time Frame: Week-12 and Week-24 ]
    compare coping between study arms


Other Outcome Measures:
  • Additional Resource Utilization [ Time Frame: from date of randomization until date of death, assessed up to 3 years ]
    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 ]

Enrollment: 350
Study Start Date: May 2011
Estimated Study Completion Date: December 2018
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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
Results First Received: February 16, 2017
Last Updated: April 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: will share deindentified data with proper IRB approval

Keywords provided by Jennifer Temel, MD, Massachusetts General Hospital:
Palliative care
Lung
Gastric
Liver
Pancreatic
Esophageal
Caregiver

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

ClinicalTrials.gov processed this record on September 21, 2017