Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Palliative Care Group
Integrated Palliative Care Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Non-small Cell Lung Cancer focused on measuring palliative care
Eligibility 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Palliative Care Group
Integrated Palliative Care Group
Arm Description
Outcomes
Primary Outcome Measures
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Secondary Outcome Measures
Assess the impact of early integration with palliative care on mood and illness understanding.
Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.
Compare hospice referrals and length of stay on hospice between study arms.
Compare outpatient code status documentation between study arms.
Compare the percentage of patients on each arm who received chemotherapy within one month of death.
Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting.
Health Care Costs
We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm
Full Information
NCT ID
NCT01038271
First Posted
December 21, 2009
Last Updated
March 19, 2018
Sponsor
Massachusetts General Hospital
Collaborators
American Society of Clinical Oncology
1. Study Identification
Unique Protocol Identification Number
NCT01038271
Brief Title
Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Society of Clinical Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
palliative care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Palliative Care Group
Arm Type
Active Comparator
Arm Title
Integrated Palliative Care Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Standard Palliative Care Group
Intervention Description
Participant is referred to the Palliative Care Team at any time.
Intervention Type
Other
Intervention Name(s)
Integrated Palliative Care Intervention
Intervention Description
Participant meets with the Palliative Care Team within 3 weeks of being randomized
Primary Outcome Measure Information:
Title
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Assess the impact of early integration with palliative care on mood and illness understanding.
Time Frame
3 years
Title
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
Title
Compare hospice referrals and length of stay on hospice between study arms.
Time Frame
3 years
Title
Compare outpatient code status documentation between study arms.
Time Frame
3 years
Title
Compare the percentage of patients on each arm who received chemotherapy within one month of death.
Time Frame
3 years
Title
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
Title
Health Care Costs
Description
We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm
Time Frame
After death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Temel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20818875
Citation
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.
Results Reference
result
PubMed Identifier
21417739
Citation
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.
Results Reference
result
PubMed Identifier
21555700
Citation
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.
Results Reference
result
PubMed Identifier
22203758
Citation
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.
Results Reference
result
PubMed Identifier
22430269
Citation
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.
Results Reference
result
PubMed Identifier
23358690
Citation
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.
Results Reference
result
Learn more about this trial
Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
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