proqol - sloan - the north central cancer treatment group
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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
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Breaking News
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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-
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Median survival (months) across sites
Site BMA- BMA+ P-valueGI 9.1 16.7 <0.0001GU 15.5 52.4* 0.0032Lung 7.0 10.8 0.0003Breast 16.6 26.2 0.0002
* Not reached (projected)
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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)
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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)
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Is this convincing evidence that BMA+ is a promising prognostic
factor for cancer patient survival?
•What is BMA+?
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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)
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QOL as a prognostic indicatorQOL as a prognostic indicatorQOL 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 LASAs comparing 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-item Key advantage: NCCTG uses simple single-item assessmentsassessments
• Data being compiled and analyzedData being compiled and analyzed
• Collate findings from multiple cooperative groups, Collate findings from multiple cooperative groups, comparing prognostic power of single-item LASAs comparing 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-item Key advantage: NCCTG uses simple single-item assessmentsassessments
• Data being compiled and analyzedData being compiled and analyzed
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Overall QOL and FatigueOverall QOL and Fatigueas routine assessmentsas routine assessmentsOverall QOL and FatigueOverall QOL and Fatigueas 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
• 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
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PROMISPROMISPROMISPROMIS
P atientP atientR eportedR eported
OutcomesOutcomes
M easurementM easurement
I nformationI nformation
S ystemS ystem
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Goal of RFAGoal of RFAGoal of RFAGoal of RFA
Improve assessmentImprove assessment of self- of self-reported reported
symptoms and other domains of symptoms and other domains of health-health-
related quality of life across a wide related quality of life across a wide range of chronic diseasesrange of chronic diseases
Improve assessmentImprove assessment of self- of self-reported reported
symptoms and other domains of symptoms and other domains of health-health-
related quality of life across a wide related quality of life across a wide range of chronic diseasesrange of chronic diseases
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Broad ObjectivesBroad ObjectivesBroad ObjectivesBroad Objectives
• Develop and test a large bank of Develop and test a large bank of items measuring PROsitems measuring PROs
• Create a CAT for efficient Create a CAT for efficient assessment of PROs across a range assessment of PROs across a range of chronic diseasesof chronic diseases
• Create a publicly available, adaptable Create a publicly available, adaptable and sustainable system allowing and sustainable system allowing clinical researchers access to a clinical researchers access to a common item repository and CATcommon item repository and CAT
• Develop and test a large bank of Develop and test a large bank of items measuring PROsitems measuring PROs
• Create a CAT for efficient Create a CAT for efficient assessment of PROs across a range assessment of PROs across a range of chronic diseasesof chronic diseases
• Create a publicly available, adaptable Create a publicly available, adaptable and sustainable system allowing and sustainable system allowing clinical researchers access to a clinical researchers access to a common item repository and CATcommon item repository and CAT
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StructureStructureStructureStructure
Collaborative agreement network: Collaborative agreement network:
Patient Reported Outcomes Measurement Patient Reported Outcomes Measurement Information System (“PROMIS”) Information System (“PROMIS”)
Consisting of:Consisting of:
• 6 Primary Research Sites 6 Primary Research Sites
• Statistical Coordinating CenterStatistical Coordinating Center
• Steering CommitteeSteering Committee
• Scientific Advisory BoardScientific Advisory Board
Collaborative agreement network: Collaborative agreement network:
Patient Reported Outcomes Measurement Patient Reported Outcomes Measurement Information System (“PROMIS”) Information System (“PROMIS”)
Consisting of:Consisting of:
• 6 Primary Research Sites 6 Primary Research Sites
• Statistical Coordinating CenterStatistical Coordinating Center
• Steering CommitteeSteering Committee
• Scientific Advisory BoardScientific Advisory Board
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PROMIS NetworkPROMIS NetworkPROMIS NetworkPROMIS Network
UNC –Chapel Hill ● UNC –Chapel Hill ●
● Duke University● Duke University
● Stanford University● Stanford University
Stony Brook University
●
Stony Brook University
●● University of Pittsburgh● University of Pittsburgh
● University of Washington● University of Washington
CORE ♥CORE ♥ ●
NIHNIH● NIHNIH
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What What PROMISPROMIS Promises PromisesWhat What PROMISPROMIS Promises Promises
P recisionP recisionR epositoryR epository
Outcome toolsOutcome tools
M ethodologiesM ethodologies
I nterpretabilityI nterpretability
S oftwareS oftware
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Item Banking and Item Banking and Computerized Adaptive Testing (CAT)Computerized Adaptive Testing (CAT)
Item Banking and Item Banking and Computerized Adaptive Testing (CAT)Computerized Adaptive Testing (CAT)
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NCCTG and PROMISNCCTG and PROMISNCCTG and PROMISNCCTG and PROMIS
• Grant submitted with aims:Grant submitted with aims:• 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..
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Roles of the PROQOL Committee
• Develop and carry out focused programof research
Role 2
Role 1
• Support the disease-oriented committees
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Roles of the PROQOL Committee
Role 1
• Support the disease-oriented committees
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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
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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
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Specific Aims
3 Value added of QOL• Continue methodological work on estimating
the clinical significance and the value addedof 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 designand conduct
Role 2 Focused program of research
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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
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• 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
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QOL & Genetics
• D. Mirjam Sprangers – co-chair of geneqol consortium
• Research agenda workshop February, 2009, Rochester, MN
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Specific Aims
3 Value added of QOL• Continue methodological work on estimating
the clinical significance and the value addedof 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 designand conduct
Role 2 Focused program of research
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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
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• 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
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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
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• 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
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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
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Development of the Patient-Reported Outcomes Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE)Adverse Events (PRO-CTCAE)
Development of the Patient-Reported Outcomes Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE)Adverse Events (PRO-CTCAE)
• National Cancer Institute, Div of Cancer Control and Pop SciencesNational Cancer Institute, Div of Cancer Control and Pop Sciences
• The resulting PRO-CTCAE will:The resulting PRO-CTCAE will:• 1) be comprehensive to 1) be comprehensive to capture a range of symptomscapture a range of symptoms and and
functioning that enhances monitoring of adverse events;functioning that enhances monitoring of adverse events;• 2) have 2) have minimal burdenminimal burden on the patient in terms of survey on the patient in terms of survey
length and comprehension;length and comprehension;• 3) be 3) be adaptable for translation into multiple languagesadaptable for translation into multiple languages to to
accommodate the diversity of patients who participate in NCI-accommodate the diversity of patients who participate in NCI-sponsored clinical trials;sponsored clinical trials;
• 4) include both 4) include both paper and electronic administrationpaper and electronic administration;;• 5) be fully 5) 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 the 6) meet the standards of compatibility within the CaBIGCaBIG
specifications; andspecifications; and• 7) have 7) have minimal administrative burdenminimal administrative burden for health care for health care
providers who will collect and interpret data for reporting providers 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 also The contract will also validatevalidate the PRO-CTCAE and demonstrate the PRO-CTCAE and demonstrate the the feasibilityfeasibility of integrating the system within NCI-sponsored trials. of integrating the system within NCI-sponsored trials.
• National Cancer Institute, Div of Cancer Control and Pop SciencesNational Cancer Institute, Div of Cancer Control and Pop Sciences
• The resulting PRO-CTCAE will:The resulting PRO-CTCAE will:• 1) be comprehensive to 1) be comprehensive to capture a range of symptomscapture a range of symptoms and and
functioning that enhances monitoring of adverse events;functioning that enhances monitoring of adverse events;• 2) have 2) have minimal burdenminimal burden on the patient in terms of survey on the patient in terms of survey
length and comprehension;length and comprehension;• 3) be 3) be adaptable for translation into multiple languagesadaptable for translation into multiple languages to to
accommodate the diversity of patients who participate in NCI-accommodate the diversity of patients who participate in NCI-sponsored clinical trials;sponsored clinical trials;
• 4) include both 4) include both paper and electronic administrationpaper and electronic administration;;• 5) be fully 5) 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 the 6) meet the standards of compatibility within the CaBIGCaBIG
specifications; andspecifications; and• 7) have 7) have minimal administrative burdenminimal administrative burden for health care for health care
providers who will collect and interpret data for reporting providers 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 also The contract will also validatevalidate the PRO-CTCAE and demonstrate the PRO-CTCAE and demonstrate the the feasibilityfeasibility of integrating the system within NCI-sponsored trials. of integrating the system within NCI-sponsored trials.
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PRO-CTCAE ProjectPRO-CTCAE ProjectPRO-CTCAE ProjectPRO-CTCAE Project
• Items have been drafted Items have been drafted
• Testing of items now happening with Testing of items now happening with patients, cognitive interviewspatients, cognitive interviews
• Mayo/NCCTG will be one of the test Mayo/NCCTG will be one of the test sitessites
• Part of the PROMIS grant projectPart of the PROMIS grant project
• Items have been drafted Items have been drafted
• Testing of items now happening with Testing of items now happening with patients, cognitive interviewspatients, cognitive interviews
• Mayo/NCCTG will be one of the test Mayo/NCCTG will be one of the test sitessites
• Part of the PROMIS grant projectPart of the PROMIS grant project
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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
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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
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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
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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.
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Login Page
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Nurse/Staff Data Entry Page
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Patient Survey: LASA
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Survey Summary by Week and QOL Change since last visit (Table)
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Overall QOL Deficit Management (LASA #1– LASA #6g, LASA 10-12)
• Specific QOL domain deficits
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Adult Cancer Pain (LASA #8)
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Deficit in Cancer-Related Fatigue (LASA #9)
Treat as usual
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Cancer-Related Fatigue (ET-4)
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• 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
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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
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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?)
