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PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
PROQOL - Sloan - The North Central Cancer Treatment Group
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PROQOL - Sloan - The North Central Cancer Treatment Group

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  • It is my privilege today to report on the activities of the NCCTG Quality of Life Committee. A QOL Working Group was formed in 1999 to facilitate efficient, effective, and systematic incorporation of QOL endpoints into NCCTG treatment trials where appropriate. The QOL Working Group became a Committee in 2001 with a rating of outstanding to excellent in the previous grant application. The present application proposes the QOL Committee as a Discipline-oriented Scientific Committee for the next six years.
  • <number>
    Kaplan-Meier estimate survival plots displayed here indicated a median survival of 9.2 months among patients whose QOL was clinically deficient, compared to a median survival of 16.8 months for patients who reported a non-deficient qol at baseline. Hence, a patient reported baseline QOL score of 50 or below, corresponded to a 7.6 month deficit in median survival.
  • <number>
    The survival analysis was repeated for individual tumor types with results displayed in this table. Results for GI, GU, lung and breast cancer patients all indicated survival deficits among patients who reported clinically deficient baseline QOL.
  • <number>
    A cox proportional hazard model was subsequently used to assess the impact of other covariates on the basic finding. Being from a minority population was not a contributing factor for survival in this analysis. Not surprisingly, Tumor type and Performance score contributed to patient survival. However, even after controlling for all these other factors, the indication of a clinically deficient baseline QOL contributed significantly to the prediction of patient survival.
  • <number>
    The theoretical framework from Wilson and Cleary indicates that Quality of life-related variables such as a patient’s perception of their own well-being can impact treatment outcome. Evidence from the literature for the prognostic capability of patient-reported outcomes has been mounting in recent years. For example, in March of this year, Carolyn Gotay and colleagues reported that based on their literature review they found that in 36 of 39 studies, at least one Patient-reported outcomes was significantly associated with overall survival. Among the patient-reported outcomes s involved, patient Quality of life was indicated as prognostic in 15 studies.
  • <number>
    Subsequently, we replaced the visual analogue scale with a numerical analogue scale. Psychometric comparisons published elsewhere have indicated that the two methods provide virtually identical results (Sloan, 2002; Huschka, 2005; Locke, 2007). Circling a number is easier for the patients and more reflective of the level of precision they can provided than placing an X in a box. Further, technician time is saved.
  • The QOL Committee has two roles within the NCCTG: 1) to support the disease-oriented committees to incorporate QOL-related research hypotheses into the evaluation of disease-specific cancer treatments; and 2) to develop and carry out a focused program of research into the assessment of QOL endpoints, using NCCTG clinical trials as an investigational platform.
  • The QOL Committee has two roles within the NCCTG: 1) to support the disease-oriented committees to incorporate QOL-related research hypotheses into the evaluation of disease-specific cancer treatments; and 2) to develop and carry out a focused program of research into the assessment of QOL endpoints, using NCCTG clinical trials as an investigational platform.
  • We have specified three research aims for the next grant period.
    (click) First, we will explore the relationship between genetics and QOL.
    (click) Second, we will improve the clinical trial patient experience to inform and improve clinical trial design and conduct.
    (click) Finally, we will continue methodological work on estimating the clinical significance and the value added of QOL assessments.
  • We will attempt to expand on these preliminary findings presented in the ASCO plenary session by returning to the data in N9741 to include additional genetic markers. For example, we will investigate the role of the APOE epsilon 4 allele which has been indicated as potentially having a relationship to emotional functioning. We also have planned studies in the lung, breast, and neuro-oncology groups to explore possible relationship across other tumors and to identify which aspects of QOL might be more or less influenced by genetics.
  • We have specified three research aims for the next grant period.
    (click) First, we will explore the relationship between genetics and QOL.
    (click) Second, we will improve the clinical trial patient experience to inform and improve clinical trial design and conduct.
    (click) Finally, we will continue methodological work on estimating the clinical significance and the value added of QOL assessments.
  • We will attempt to expand on these preliminary findings presented in the ASCO plenary session by returning to the data in N9741 to include additional genetic markers. For example, we will investigate the role of the APOE epsilon 4 allele which has been indicated as potentially having a relationship to emotional functioning. We also have planned studies in the lung, breast, and neuro-oncology groups to explore possible relationship across other tumors and to identify which aspects of QOL might be more or less influenced by genetics.
  • Transcript

    • 1. CP1223416-1 Patient Reported Outcomes Quality of Life Committee (PROQOL) Jeff A. Sloan, PhD Chair Michele Halyard, MD Vice Chair Paul Schaefer, MD Community Co-Chair July 29, 2009 Update
    • 2. CP1223416-2
    • 3. CP1223416-3 Breaking News
    • 4. CP1223416-4 Survival Curves for n=3704 cancer patients (Biomarker Assay (BMA) Positive versus Negative) Median Survival (Months) Median (95% CI) Log- rank P-value BMA+ 16.8 (16.1, 17.4) 0.0001 BMA- 9.2 (8.1, 10.6) Survival Time (Years) BMA+ BMA-
    • 5. CP1223416-5 Median survival (months) across sites Site BMA- BMA+ P-value GI 9.1 16.7 <0.0001 GU 15.5 52.4* 0.0032 Lung 7.0 10.8 0.0003 Breast 16.6 26.2 0.0002 * Not reached (projected)
    • 6. CP1223416-6 Multivariate Cox Model for Survival Variable P-Value Hazard Ratio (95% CI) BMA- <.001 1.56 (1.40, 1.75) Performance Score (1-2 versus 0) <.001 1.77 (1.62, 1.93) Age 0.075 1.00 (1.00, 1.01) Minority 0.219 0.91 (0.79, 1.06) GI <.001 1.37 (1.14, 1.65) Lung <.001 2.02 (1.65, 2.47) Breast 0.006 0.64 (0.47, 0.88) GU 0.078 1.46 (0.96, 2.21)
    • 7. CP1223416-7 Replication of results • A recent literature review (n=13,874) indicated that in 36 of 39 studies indicated that analogues of BMA+ were significantly associated with overall survival (Gotay, JCO, 26: 1355 -1363, March 2008) • Meta analysis involving over 10,000 patients indicated that BMA+ analogue was prognostic for survival (Efficace, ASCO 2008)
    • 8. CP1223416-8 Is this convincing evidence that BMA+ is a promising prognostic factor for cancer patient survival? •What is BMA+?
    • 9. CP1223416-9 BMA+ = a score of 5 or less in patient-reported QOL on a 0-10 scale Directions: Please circle the number (0-10) best reflecting your response to the following that describes your feelings during the past week, including today. How would you describe: 1. your overall Quality of Life? 0 1 2 3 4 5 6 7 8 9 10 As bad as As good as it can be it can be This is a reliable and valid measure for cancer patient populations (Sloan, 2002; Huschka, 2005; Locke, 2007)
    • 10. 1010 QOL as a prognostic indicatorQOL as a prognostic indicator • Collate findings from multiple cooperative groups,Collate findings from multiple cooperative groups, comparing prognostic power of single-item LASAscomparing prognostic power of single-item LASAs (ncctg) versus multi-item(ncctg) versus multi-item • Primary outcome: overall survivalPrimary outcome: overall survival • Prognostic variables: overall QOL, fatiguePrognostic variables: overall QOL, fatigue • Key advantage: NCCTG uses simple single-itemKey advantage: NCCTG uses simple single-item assessmentsassessments • Data being compiled and analyzedData being compiled and analyzed
    • 11. 1111 Overall QOL and FatigueOverall QOL and Fatigue as routine assessmentsas routine assessments • To be added to ALL treatment trialsTo be added to ALL treatment trials • Will be part of the on-study formWill be part of the on-study form • Two simple single-item LASAsTwo simple single-item LASAs • Implementation fourth quarter 2009Implementation fourth quarter 2009
    • 12. 1212 PROMISPROMIS P atient R eported Outcomes Measurement I nformation S ystem
    • 13. 1313 Goal of RFAGoal of RFA Improve assessmentImprove assessment of self-of self- reportedreported symptoms and other domains ofsymptoms and other domains of health-health- related quality of life across a widerelated quality of life across a wide range of chronic diseasesrange of chronic diseases
    • 14. 1414 Broad ObjectivesBroad Objectives • Develop and test a large bank ofDevelop and test a large bank of items measuring PROsitems measuring PROs • Create a CAT for efficientCreate a CAT for efficient assessment of PROs across aassessment of PROs across a range of chronic diseasesrange of chronic diseases • Create a publicly available,Create a publicly available, adaptable and sustainableadaptable and sustainable system allowing clinicalsystem allowing clinical researchers access to a commonresearchers access to a common
    • 15. 1515 StructureStructure Collaborative agreement network:Collaborative agreement network: Patient Reported Outcomes MeasurementPatient Reported Outcomes Measurement Information System (“PROMIS”)Information System (“PROMIS”) Consisting of:Consisting of: • 6 Primary Research Sites6 Primary Research Sites • Statistical Coordinating CenterStatistical Coordinating Center • Steering CommitteeSteering Committee • Scientific Advisory BoardScientific Advisory Board
    • 16. 1616 PROMIS NetworkPROMIS Network UNC –Chapel Hill ●● Duke University ● Stanford University Stony Brook University ● ● University of Pittsburgh ● University of Washington CORE ♥ ● NIHNIH
    • 17. 1717 WhatWhat PROMISPROMIS PromisesPromises P recision R epository Outcome tools Methodologies I nterpretability S oftware
    • 18. 1818 Item Banking andItem Banking and Computerized Adaptive Testing (CAT)Computerized Adaptive Testing (CAT)
    • 19. 1919 NCCTG and PROMISNCCTG and PROMIS • Grant submitted with aims:Grant submitted with aims: SCIENTIFIC AIMS 1. Test the relative performance psychometrics of the PROMIS tools and the new PRO-CTC measures versus simple single- item numerical analogues. 2. Estimate the prognostic capabilities of collecting baseline PRO data for DFS, PFS and OS. 3. Explore the relationship between the PRO measures and selected genetic polymorphisms..
    • 20. CP1223416-20 Roles of the PROQOL Committee • Develop and carry out focused program of research Role 2 Role 1 • Support the disease-oriented committees
    • 21. CP1223416-21 Roles of the PROQOL Committee Role 1 • Support the disease-oriented committees
    • 22. CP1223416-22 Infrastructure Expansion: Liaisons • Neuro……………Paul Brown, MD • GI………………...Axel Grothey, MD, . Joleen Turja, MD • Breast…….......…Michele Halyard, MD, Amylou Dueck, PhD • Lung……………...Nina Garces, MD, . Nathan Foster, MS • Melanoma……….Barb Pockaj, MD, Svetomir Markovic, MD
    • 23. CP1223416-23 Interaction with other groups • GOG-0236 – Flexitouch massage therapy for lower extermity lymphedema for patients with gynecologic malignancies, closed due to poor accrual. • ACOSOG Z6051: Laporoscopic rectal cancer trial, open and accruing. • ACOSOG Z1052: Cryoablation for breast cancer, open and accruing. • E3201 – bowel function questionnaire validation data under analysis
    • 24. CP1223416-24 Specific Aims 3 Value added of QOL • Continue methodological work on estimating the clinical significance and the value added of QOL assessments 1 Genetics and QOL • Explore the relationship between genetics and QOL 22 Improve clinical trial design • Improve the clinical trial patient experience to inform and improve clinical trial design and conduct Role 2 Focused program of research
    • 25. CP1223416-25 Specific Research Questions • Are there other genetic markers? (e.g., APOE epsilon 4 allele) • Is there consistency across tumor sites? • Breast cancer (N063D) • Lung cancer (N0222, N01C9) • Neuro-oncology (N0577) • Which aspects of QOL are more/less influenced by genetics? Aim 1 Genetics and QOL
    • 26. CP1223416-26 • TITLE: Exploring the Relationship between Selected Genetic Polymorphisms of Colorectal Cancer Patients and Quality of Life (QOL) Domains of Mood: A Correlative Study to North Central Cancer Treatment Group (NCCTG) Phase III Trial N9741 • PRINCIPAL INVESTIGATORS: Jeff A. Sloan, Ph.D. & Gen Shinozaki, M.D. • Potential genetic polymorphsims identified by Dr. Shinozaki in pilot study New Concept 494 Patients from N9741 with QOL and genetic data Run assay on to produce data on polymorphisms 5HTTLPR and related markers
    • 27. CP1223416-27 QOL & Genetics • D. Mirjam Sprangers – co-chair of geneqol consortium • Research agenda workshop February, 2009, Rochester, MN
    • 28. CP1223416-28 Specific Aims 3 Value added of QOL • Continue methodological work on estimating the clinical significance and the value added of QOL assessments 1 Genetics and QOL • Explore the relationship between genetics and QOL 22 Improve clinical trial design • Improve the clinical trial patient experience to inform and improve clinical trial design and conduct Role 2 Focused program of research
    • 29. CP1223416-29 Specific Research Questions • Are there other genetic markers? (e.g., APOE epsilon 4 allele) (N9741) • Is there consistency across tumor sites? • Breast cancer (N063A) • Lung cancer (N0222, N01C9) • Neuro-oncology (N0577) • Which aspects of QOL are more/less influenced by genetics? Aim 1 Genetics and PROQOL
    • 30. CP1223416-30 • TITLE: Exploring the Relationship between Selected Genetic Polymorphisms of Colorectal Cancer Patients and Quality of Life (QOL) Domains of Mood: A Correlative Study to North Central Cancer Treatment Group (NCCTG) Phase III Trial N9741 • PRINCIPAL INVESTIGATORS: Jeff A. Sloan, Ph.D. & Gen Shinozaki, M.D. • Potential genetic polymorphsims identified by Dr. Shinozaki in pilot study New Concept 494 Patients from N9741 with QOL and genetic data Run assay on to produce data on polymorphisms 5HTTLPR and related markers
    • 31. CP1223416-31 QOL & Genetics • Research agenda workshop • February 26-28, 2009, Rochester, MN • Challenge grant submitted • Special session at ISOQOL, New Orleans, October 29-31, 2009 • Special section of Quality of Life Research
    • 32. CP1223416-32
    • 33. CP1223416-33 • N0392 WIWI now on six open studies, to provide feedback for patient experience, satisfaction, QOL • A quality of life assessment of patients participating in phase I clinical trials confirms a decrease during treatment, developed the WIWI Aim 2 Better clinical trial design
    • 34. CP1223416-34 Improving clinical trial design • Compliance issues in completion of patient- reported outcomes in a series of NCCTG/Mayo clinical trials • Comparing and Validating Simple measures of Patient-reported Peripheral Neuropathy (PRPN) for NCCTG Clinical Trials: a Pooled Analysis of 2440 Patients
    • 35. 3535 Development of the Patient-Reported OutcomesDevelopment of the Patient-Reported Outcomes version of the Common Terminology Criteria forversion of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)Adverse Events (PRO-CTCAE) • National Cancer Institute, Div of Cancer Control and PopNational Cancer Institute, Div of Cancer Control and Pop SciencesSciences • The resulting PRO-CTCAE will:The resulting PRO-CTCAE will: • 1) be comprehensive to1) be comprehensive to capture a range of symptomscapture a range of symptoms andand functioning that enhances monitoring of adverse events;functioning that enhances monitoring of adverse events; • 2) have2) have minimal burdenminimal burden on the patient in terms of surveyon the patient in terms of survey length and comprehension;length and comprehension; • 3) be3) be adaptable for translation into multiple languagesadaptable for translation into multiple languages toto accommodate the diversity of patients who participate inaccommodate the diversity of patients who participate in NCI-sponsored clinical trials;NCI-sponsored clinical trials; • 4) include both4) include both paper and electronic administrationpaper and electronic administration;; • 5) be fully5) be fully integrated and complement the revised CTCAEintegrated and complement the revised CTCAE (version 4.0);(version 4.0); • 6) meet the standards of compatibility within the6) meet the standards of compatibility within the CaBIGCaBIG specifications; andspecifications; and • 7) have7) have minimal administrative burdenminimal administrative burden for health carefor health care providers who will collect and interpret data for reportingproviders who will collect and interpret data for reporting adverse events and for informing patient care.adverse events and for informing patient care. • The contract will alsoThe contract will also validatevalidate the PRO-CTCAE and demonstratethe PRO-CTCAE and demonstrate thethe feasibilityfeasibility of integrating the system within NCI-sponsoredof integrating the system within NCI-sponsored trials.trials.
    • 36. 3636 PRO-CTCAE ProjectPRO-CTCAE Project • Items have been draftedItems have been drafted • Testing of items now happening withTesting of items now happening with patients, cognitive interviewspatients, cognitive interviews • Mayo/NCCTG will be one of the testMayo/NCCTG will be one of the test sitessites • Part of the PROMIS grant projectPart of the PROMIS grant project
    • 37. CP1223416-37 REALTIME QOL Assessment • QOL committee strategic goal to investigate whether real time use of QOL data in clinical practice adds to patient care • Pilots in Rad Onc & Neuro-Onc planned • Ultimate goal to look at using QOL data collection in clinic setting • Use of LASA 12 instrument • Submission for external funding planned • Potential for larger NCCTG wide study
    • 38. CP1223416-38 Clinical Significance of Real-time Quality of Life (QOL) Data • Specific Aims • To determine if patient QOL can be improved by the real-time use of QOL data during radiation treatments • To determine whether the availability of real-time QOL assessment data in radiation oncology practice increases the acceptance of and utilization of such information by physicians • To evaluate the quality of patient-physician relationship with real-time use of QOL data compared to interactions where the QOL data are not utilized
    • 39. CP1223416-39 Process Flow • Physician can view the patient survey for current visit as well as the weekly summary (if available) • Absolute value of 5 or more on the measure will be bolded and highlighted in red as alert values • Any change of 2 points or more on the measure since the last visit will be bolded and highlighted in green as alert values
    • 40. CP1223416-40 Process Flow • LASA survey results table: • The table will include the survey results of the current visit as well as all of the previous visits. The QOL change since last visit (if available) will be displayed in the last column of the table.
    • 41. CP1223416-41 Login Page
    • 42. CP1223416-42 Nurse/Staff Data Entry Page
    • 43. CP1223416-43 Patient Survey: LASA
    • 44. CP1223416-44 Survey Summary by Week and QOL Change since last visit (Table)
    • 45. CP1223416-45 Overall QOL Deficit Management (LASA #1– LASA #6g, LASA 10-12) • Specific QOL domain deficits
    • 46. CP1223416-46 Adult Cancer Pain (LASA #8)
    • 47. CP1223416-47 Deficit in Cancer-Related Fatigue (LASA #9) Treat as usual
    • 48. CP1223416-48 Cancer-Related Fatigue (ET-4)
    • 49. CP1223416-49 • Implementing a PRO-based treatment process for cancer patients New Concept Assess cancer patient QOL with LASAs Routine care Implement clinical pathways feedback system for treatment decision-making and monitoring • Primary endpoint: OS, DFSPrimary endpoint: OS, DFS •Secondary endpoints: toxicity, QOL, satisfaction with careSecondary endpoints: toxicity, QOL, satisfaction with care
    • 50. CP1223416-50 Real-time Projects • Pilot open in Mayo Scottsdale • Rochester pilot in neuro patients open this year • Second pilot in three selected NCCTG sites developed, open 2010
    • 51. CP1223416-51 Prioritization • How do we organize all this “stuff”? • Tumor groups prioritize their studies via online priority list • Annual retreats to produce timeline • Master workload lists for staff • Perhaps at NCCTG meetings (question?)
    • 52. CP1223416-52 MarilynMarilynAlanAlan Thank You! References: jsloan@mayo.edu

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