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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01038271
First received: December 21, 2009
Last updated: May 6, 2013
Last verified: May 2013
  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 3

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:


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 ]
  • Health Care Costs [ Time Frame: After death ] [ Designated as safety issue: No ]
    We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm


Estimated Enrollment: 150
Study Start Date: May 2006
Estimated Study Completion Date: September 2013
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
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: 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

Publications:

Responsible Party: Jennifer Temel, MD, Thoracic Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01038271     History of Changes
Other Study ID Numbers: 06-030
Study First Received: December 21, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
palliative care

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014