Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT01038271
Last Updated: 2018-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2006-05-31
2017-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard Palliative Care Group
Standard Palliative Care Group
Participant is referred to the Palliative Care Team at any time.
Integrated Palliative Care Group
Integrated Palliative Care Intervention
Participant meets with the Palliative Care Team within 3 weeks of being randomized
Interventions
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Standard Palliative Care Group
Participant is referred to the Palliative Care Team at any time.
Integrated Palliative Care Intervention
Participant meets with the Palliative Care Team within 3 weeks of being randomized
Eligibility Criteria
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Inclusion Criteria
* 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
* Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
18 Years
ALL
No
Sponsors
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American Society of Clinical Oncology
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Jennifer Temel, MD
Thoracic Oncology
Principal Investigators
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Jennifer Temel, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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06-030
Identifier Type: -
Identifier Source: org_study_id
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