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

Sponsor:	Massachusetts General Hospital
Collaborator:	American Society of Clinical Oncology
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01038271

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Other: Standard Palliative Care Group Other: Integrated Palliative Care Intervention	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hospice Care Lung Cancer Palliative Care

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the impact of early integration with palliative care on mood and illness understanding. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare hospice referrals and length of stay on hospice between study arms. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare outpatient code status documentation between study arms. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Compare the percentage of patients on each arm who received chemotherapy within one month of death. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Standard Palliative Care Group	Other: Standard Palliative Care Group Participant is referred to the Palliative Care Team at any time.
Active Comparator: Integrated Palliative Care Group	Other: Integrated Palliative Care Intervention Participant meets with the Palliative Care Team within 3 weeks of being randomized

Detailed Description:

Participants with advanced small-cell lung cancer, will be asked to fill out some quality of life questionnaires that help to measure their quality of life (QOL), mood and understanding of their illness. They will also be asked to identify an important person in their life, either a relative or friend, who they count on for help and support. The research staff will contact that individual and ask them to if they want to participate in the caregiver part of this study.
Lung cancer participants will then be randomized into one of the two study groups: integrated palliative care or standard palliative care.
Participants assigned to the Standard palliative care group will be referred to the Palliative Care Team at their doctor's or their request at any time. At that time the Palliative Care Team (PCT) will follow and treat the participant as they would any other cancer patient. Research staff will request the participant to fill out QOL, mood & illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
Participants assigned to the Integrated Palliative Care group will have an appointment with the Palliative Care Team within 3 weeks of being randomized. The palliative care physician will formulate a care plan based on the participant's and caregiver's issues and needs. The PCT will meet with the participant on a regular basis, a minimum of every 6 weeks. These visits wil vary with the participant's needs and may include individual or group meetings with the physicians, nurse practitioners, social workers or chaplains. Research staff will ask you to fill out QOL, mood & illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
Participants will be in this research study for about 24 weeks or 6 months. After this 6 month period is over, care by the Palliative Care Team my continue but the participants will not be asked to fill out more questionnaires.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038271

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

American Society of Clinical Oncology

Investigators

Principal Investigator:

Jennifer Temel, MD

Massachusetts General Hospital

More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01038271 History of Changes
Other Study ID Numbers:	06-030
Study First Received:	December 21, 2009
Last Updated:	December 22, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

palliative care

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 21, 2012