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

March 19, 2018 updated by: Jennifer Temel, MD, Massachusetts General Hospital

A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of early integration with palliative care on mood and illness understanding.
Time Frame: 3 years
3 years
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
3 years
Compare hospice referrals and length of stay on hospice between study arms.
Time Frame: 3 years
3 years
Compare outpatient code status documentation between study arms.
Time Frame: 3 years
3 years
Compare the percentage of patients on each arm who received chemotherapy within one month of death.
Time Frame: 3 years
3 years
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
3 years
Health Care Costs
Time Frame: After death
We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm
After death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

American Society of Clinical Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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