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Study Rationale

Early palliative care improves quality of life, reduces aggressiveness of care at the end-of-life and prolongs survival in stage IV NSCLC patients: Results of a phase III randomized trial. Temel JS, Greer JA, Gallagher E, Admane S, Pirl WF, Jackson VA, Dahlin C, Muzikansky A, Jacobsen J, Lynch TJ.

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Study Rationale

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  1. Early palliative care improves quality of life, reduces aggressiveness of care at the end-of-life and prolongs survival in stage IV NSCLC patients:Results of a phase III randomized trial Temel JS, Greer JA, Gallagher E, Admane S, Pirl WF, Jackson VA, Dahlin C, Muzikansky A, Jacobsen J, Lynch TJ

  2. Study Rationale Current Care Model Proposed Care Model www.iom.edu

  3. Integrated Oncology and Palliative Care in the Ambulatory Care Setting 50 patients with newly diagnosed metastatic NSCLC Meet with palliative care at least monthly during 1st 6 months of care Temel, JCO (25)17, 2007

  4. Study Design Meet with palliative care within 3 weeks of signing consent and at least monthly thereafter Early palliative care integrated with standard oncology care RANDOMIZED 150 patients with newly diagnosed metastatic NSCLC Baseline Data Collection Meet with palliative care only when requested by patient, family or oncology clinician. Standard oncology care

  5. Early Palliative Care Study Procedures www.nationalconsensusproject.org

  6. Study Objectives Primary Objective: • Measure the difference in QOL between the two study arms at 12 weeks. Secondary Objectives: • Psychological distress at 12 weeks • Quality of end-of-life care • Resource utilization at the end-of-life • Documentation of resuscitation preference in the medical record

  7. Study Eligibility • Metastatic NSCLC diagnosed within the previous 8 weeks. • ECOG performance status 0-2. • Ability to read and respond to questions in English. • Planning to receive oncology care at the participating institution.

  8. Study Measures • Quality of life • FACT-Lung - Lower scores indicative of greater symptom burden • Lung Cancer Symptom (LCS): lung cancer specific symptoms • Trial Outcome Index (TOI): LCS and functional and physical well-being • Psychological Distress • Hospital Anxiety and Depression Scale (HADS) • Score of > 8 of each subscale indicative of symptoms of depression or anxiety • Patient Health Questionnaire-9 (PHQ-9) • Evaluates symptoms of major depressive disorder (MDD) using DSM-IV criteria.

  9. Data Collection • Measures of health care utilization were collected from electronic medical records. • Use of anti-cancer therapies • Hospital and emergency room visits • Dates of hospice referral • Date and location of death • Documentation of resuscitation preference

  10. Sample Size Calculation • Sample size was calculated to detect a clinically meaningful change in QOL, defined as a medium effect size of 0.5 SD. • 120 patients were required to have 80% power to detect an effect size of 0.5 SD in FACT-Lung TOI. • Due to rapid accrual, the study was amended to add an additional 30 patients. • Data were analyzed through 12/1/09.

  11. Statistical Analysis • Differences between study arms in clinical outcomes were assessed with two-sided Fisher’s Exact tests for categorical variables and independent-samples t-tests for continuous variables. • For ITT analyses, baseline values were carried forward for missing patient-reported outcome data. • Survival time was calculated from the date of consent to date of death using the Kaplan-Meier method. • Differences in survival were tested with Log Rank and Cox Proportional Hazard Model.

  12. Study Flow Assessed for eligibility (N=283) June 2006 – July 2009 Excluded (n=9) Not offered (n=60) Refused to participate (n=59) Study closed during eligibility (n=4) Randomly assigned (N=151) Standard care (N=74) Palliative care (N=77) 12 week QOL assessment: 47 completed (64%) 17 died (23%) 10 did not complete (13%) 12 week QOL assessment: 60 completed (78%) 10 died (13%) 7 not completed (9%)

  13. Patient Demographics

  14. Baseline Clinical Characteristics

  15. Baseline Quality of Life and Psychological Distress

  16. Palliative Care Visits by 12 Weeks * Died within 2 weeks of enrollment

  17. 12-week Quality of Life Measures

  18. Effect of Early PC on 12-week Psychological Distress p=0.01 p=0.66 p=0.04

  19. Change in QOL from Baseline to 12 Weeks FACT- Lung TOI FACT-Lung Mean change Early Palliative Care = + 4.2 Mean change Standard Care = - 0.4 p=0.09 Mean change Early Palliative Care = + 2.3 Mean change Standard Care = - 2.3 p=0.04

  20. Quality of EOL Care and Resource Utilization ASCO Quality Measures • No hospice • Enrolled in hospice < 3 days before death • Chemotherapy within 14 days of death (DOD) 105 deaths at time of data analysis with data on chemotherapy within 14 DOD available on 90 patients

  21. Survival Analysis Median Survival Early palliative care 11.6 mo Standard care 8.9 mo p=0.02 Early palliative care Overall survival Standard care Months Controlling for age, gender and PS, adjusted HR=0.59 (0.40-0.88), p=0.01

  22. Study Limitations • Single, tertiary-care site with a specialized group of clinicians. • Study population lacked racial/ethnic diversity. • Randomized design but no blinding to study arm. • Small number of patients on standard care arm seen by palliative care team. • Survival was not a pre-specified study endpoint. • Lack of information on mediators of patient-reported and medical outcomes.

  23. Summary • Compared with standard oncology care, integrated palliative care led to: • Improvements in QOL • Lower rates of depression • Less aggressive care at the end-of-life • Greater documentation of resuscitation preferences • Higher survival rates

  24. Discussion • Changes in QOL may be due to improved symptom management. • Decreased rates of depression may be related to improved symptom management and illness acceptance. • Prolonged survival possibly related to: • Earlier recognition and management of medical issues • Improved QOL and mood • Less chemotherapy at the end-of-life • Longer hospice admissions

  25. Acknowledgements • Funding Provided by: • ASCO Foundation • Golf Fights Cancer • The Joanne Hill Monahan Fund • Supportive Care Research Group at Massachusetts General Hospital • William Pirl, MD, MPH • Joseph Greer, Ph.D • Inga Lennes MD • Emily Gallagher, BS • Sonal Admane, MBBS, MPH • Elyse Park, Ph.D • Areej El-Jawahri, MD • Center for Palliative Care at Massachusetts General Hospital • Andrew J. Billings MD • Vicki Jackson MD • Connie Dahlin ANP • Craig Blinderman, MD • Juliet Jacobsen, MD • Amelia Cullinan, MD • Sandy Nasrallah, MD • Thoracic Oncology at Massachusetts General Hospital • Panos Fidias, MD • Alice Shaw, MD, Ph.D • Rebecca Heist, MD • Lecia Sequist, MD • Jeff Engelman, MD, Ph.D • David Barbie, MD, Ph.D. • Inga Lennes, MD • Elizabeth Lamont, MD • Jeanne Vaughn, ANP • Diane Doyle, ANP • Patricia Ostler R.N • Thoracic Oncology research nurses, administrators and staff • Yale Cancer Center • Thomas J. Lynch, MD

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