Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT01038271 | Completed

• 1 other identifier: 06-030
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.

Conditions

Non-small Cell Lung Cancer

Keywords

palliative care

Outcome Measures

Primary Outcomes (1)

• Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.

  3 years

Secondary Outcomes (7)

• Assess the impact of early integration with palliative care on mood and illness understanding.

  3 years

• Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.

  3 years

• Compare hospice referrals and length of stay on hospice between study arms.

  3 years

• Compare outpatient code status documentation between study arms.

  3 years

• Compare the percentage of patients on each arm who received chemotherapy within one month of death.

  3 years

Study Arms (2)

Standard Palliative Care Group

ACTIVE COMPARATOR

Other: Standard Palliative Care Group

Integrated Palliative Care Group

ACTIVE COMPARATOR

Other: Integrated Palliative Care Intervention

Interventions

Standard Palliative Care Group OTHER

Participant is referred to the Palliative Care Team at any time.

Standard Palliative Care Group

Integrated Palliative Care Intervention OTHER

Participant meets with the Palliative Care Team within 3 weeks of being randomized

Integrated Palliative Care Group

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed incurable NSCLC, stage IIIB with a pleural or pericardial effusion or stage IV
• Performance status 0-2
• Diagnosis of advanced NSCLC within the previous eight weeks
• Ability to read and respond to questions in English
• Permission of attending physician

You may not qualify if:

• Prior chemotherapy for metastatic disease
• Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

  PMID: 20818875 RESULT

• Jacobsen J, Jackson V, Dahlin C, Greer J, Perez-Cruz P, Billings JA, Pirl W, Temel J. Components of early outpatient palliative care consultation in patients with metastatic nonsmall cell lung cancer. J Palliat Med. 2011 Apr;14(4):459-64. doi: 10.1089/jpm.2010.0382. Epub 2011 Mar 18.

  PMID: 21417739 RESULT

• Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.

  PMID: 21555700 RESULT

• Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.

  PMID: 22203758 RESULT

• Pirl WF, Greer JA, Traeger L, Jackson V, Lennes IT, Gallagher ER, Perez-Cruz P, Heist RS, Temel JS. Depression and survival in metastatic non-small-cell lung cancer: effects of early palliative care. J Clin Oncol. 2012 Apr 20;30(12):1310-5. doi: 10.1200/JCO.2011.38.3166. Epub 2012 Mar 19.

  PMID: 22430269 RESULT

• Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.

  PMID: 23358690 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jennifer Temel, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracic Oncology

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: May 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

US (1)