Clinical trial NCT01401907: Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Small Cell Lung Cancer
Mesothelioma
Esophageal Cancer
Gastric Cancer
Liver Cancer
Pancreatic Cancer
Keywords: Palliative care
Lung
Gastric
Liver
Pancreatic
Esophageal
Caregiver
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: early palliative care
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy (Quality of Life Measure)
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy (Quality of Life Measure)
timeFrame: 24 weeks
measure: Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
timeFrame: Week-12 and Week-24
measure: Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
timeFrame: Week12 and Week 24
measure: Family Caregiver Quality of Life as Measured by the SF-36
timeFrame: Week-12 and Week-24
measure: Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
timeFrame: Week 12 and Week 24
measure: Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
timeFrame: 12 and 24 weeks
measure: Coping (Brief Cope)
timeFrame: Up to week-24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoerger M, Greer JA, Jackson VA, Park ER, Pirl WF, El-Jawahri A, Gallagher ER, Hagan T, Jacobsen J, Perry LM, Temel JS. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018 Apr 10;36(11):1096-1102. doi: 10.1200/JCO.2017.75.6676. Epub 2018 Feb 23.
citation: Greer JA, Jacobs JM, El-Jawahri A, Nipp RD, Gallagher ER, Pirl WF, Park ER, Muzikansky A, Jacobsen JC, Jackson VA, Temel JS. Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood. J Clin Oncol. 2018 Jan 1;36(1):53-60. doi: 10.1200/JCO.2017.73.7221. Epub 2017 Nov 15.