Clinical trial NCT01038271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: palliative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
First posted: 2009-12-23
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
timeFrame: 3 years
Secondary outcomes:
measure: Assess the impact of early integration with palliative care on mood and illness understanding.
timeFrame: 3 years
measure: Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.
timeFrame: 3 years
measure: Compare hospice referrals and length of stay on hospice between study arms.
timeFrame: 3 years
measure: Compare outpatient code status documentation between study arms.
timeFrame: 3 years
measure: Compare the percentage of patients on each arm who received chemotherapy within one month of death.
timeFrame: 3 years
measure: Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting.
timeFrame: 3 years
measure: Health Care Costs
timeFrame: After death
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.