Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

NCT01401907 | Completed Results DMC

• 1 other identifier: 10-434
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Cancer Therapy (Quality of Life Measure)

  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

  12 weeks

Secondary Outcomes (7)

• Functional Assessment of Cancer Therapy (Quality of Life Measure)

  24 weeks

• Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale

  Week-12 and Week-24

• Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer

  Week12 and Week 24

• Family Caregiver Quality of Life as Measured by the SF-36

  Week-12 and Week-24

• Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)

  Week 12 and Week 24

Study Arms (2)

Early Palliative Care

EXPERIMENTAL

Subjects receive standard of care with early palliative care.

Other: early palliative care

Standard of Care

NO INTERVENTION

Subjects receives standard of care

Interventions

early palliative care OTHER

patient assigned to the intervention will receive early palliative care along with standard oncology care.

Early Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant psychiatric or other co-morbid disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 29474102 DERIVED

• 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.

  PMID: 29140772 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Mesothelioma; Esophageal Neoplasms; Stomach Neoplasms; Liver Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jennifer Temel MD
• Organization: MGH

jtemel@partners.org

617-724-4000

Study Officials

• Jennifer Temel, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: early palliative care

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 25, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2019
• Last Updated: October 19, 2023
• Results First Posted: July 13, 2017

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)