Grant Number:	2R01CA060068-10A1 Interpret this number
Primary Investigator:	Cella, David
Organization:	Northshore University Healthsystem
Project Title:	Item Banking and Cat for Quality of Life Outcomes
Fiscal Year:	2005

DESCRIPTION (provided by the applicant): Optimal cancer care increasingly incorporates the patient's perspective, yet clinicians are not routinely taught how to measure patient-reported symptoms and health status. The advent of computerized adaptive testing (CAT) using item response theory (IRT) provides a unique opportunity to integrate health-related quality of life (HRQL) and symptom management research into individual clinical practice. Efficient and precise individual patient measurement paired with symptom management recommendations has the potential to improve patient satisfaction, communication and HRQL outcomes. In our currently funded project CA60068, we have developed brief-yet-accurate and user-friendly assessments of symptoms and function in individual cancer patients. We now propose to refine and broaden our current item banking program in fatigue (F), physical function (PF), pain (P), emotional distress (ED), illness impact (II), current HRQL model (Aim 1); and to test the efficacy of routine and targeted symptom monitoring (SyMon) and management for advanced cancer patients (Aim 2). We will refine and administer existing items to sufficient numbers of patients (n=2000) to evaluate measurement equivalence across gender, race and, where possible, disease type. Additionally, we will fully explore the dimensionality of the items and the usefulness of 1-PL and 2-PL IRT models. We will create CAT applications, incorporating patient-and clinician-derived estimates of clinically meaningful changes in scores to be used in Aim 2. Additionally, we propose to create four new item pools (spiritual well-being, appetite, pulmonary symptoms, and nausea) to ultimately create operational item banks. For Aim 2, we propose a 4-month efficacy study with a modified crossover design (n=140) to evaluate whether routine and targeted CAT-derived assessments of F, PF, P and ED paired with management recommendations can improve satisfaction, communication and HRQL outcomes for advanced cancer patients receiving chemotherapy. Patients will be randomized to two groups: 1) SyMon intervention for 4 months, or 2) control for 2 months and SyMon intervention for 2 months. All patients will complete CAT-based symptom measures in F, PF, P and ED before each physician visit for the 4-month study period. The intervention will consist of providing CAT-derived scores to patients, and scores with specific guideline-driven recommendations to clinicians. We will also monitor treatment/management changes, and evaluate acceptability of computer assessments and the perceived benefits of the recommendations.




Positive and negative psychosocial impacts on cancer survivors.
Authors: Yao G. , Lai J.S. , Garcia S.F. , Yount S. , Cella D. .
Source: Scientific Reports, 2023-09-07 00:00:00.0; 13(1), p. 14749.
EPub date: 2023-09-07 00:00:00.0.
PMID: 37679401
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Positive and negative psychosocial impacts on cancer survivors.
Authors: Yao G. , Lai J.S. , Garcia S.F. , Yount S. , Cella D. .
Source: Scientific Reports, 2023-09-07 00:00:00.0; 13(1), p. 14749.
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Machine-learning Modeling for Personalized Immunotherapy- An Evaluation Module.
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Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples.
Authors: Schalet B.D. , Pilkonis P.A. , Yu L. , Dodds N. , Johnston K.L. , Yount S. , Riley W. , Cella D. .
Source: Journal Of Clinical Epidemiology, 2016 May; 73, p. 119-27.
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Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior.
Authors: Askew R.L. , Cook K.F. , Revicki D.A. , Cella D. , Amtmann D. .
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PROMIS Fatigue Item Bank had Clinical Validity across Diverse Chronic Conditions.
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Promis Measures Of Pain, Fatigue, Negative Affect, Physical Function, And Social Function Demonstrated Clinical Validity Across A Range Of Chronic Conditions
Authors: Cook K.F. , Jensen S.E. , Schalet B.D. , Beaumont J.L. , Amtmann D. , Czajkowski S. , Dewalt D.A. , Fries J.F. , Pilkonis P.A. , Reeve B.B. , et al. .
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Validity of PROMIS physical function measured in diverse clinical samples.
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Bringing PROMIS to practice: brief and precise symptom screening in ambulatory cancer care.
Authors: Wagner L.I. , Schink J. , Bass M. , Patel S. , Diaz M.V. , Rothrock N. , Pearman T. , Gershon R. , Penedo F.J. , Rosen S. , et al. .
Source: Cancer, 2015-03-15 00:00:00.0; 121(6), p. 927-34.
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Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment.
Authors: Cella D. , Choi S. , Garcia S. , Cook K.F. , Rosenbloom S. , Lai J.S. , Tatum D.S. , Gershon R. .
Source: Quality Of Life Research : An International Journal Of Quality Of Life Aspects Of Treatment, Care And Rehabilitation, 2014 Dec; 23(10), p. 2651-61.
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Self-reported cognitive concerns and abilities: two sides of one coin?
Authors: Lai J.S. , Wagner L.I. , Jacobsen P.B. , Cella D. .
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Development Of A Measure Of Asthma-specific Quality Of Life Among Adults
Authors: Eberhart N.K. , Sherbourne C.D. , Edelen M.O. , Stucky B.D. , Sin N.L. , Lara M. .
Source: Quality Of Life Research : An International Journal Of Quality Of Life Aspects Of Treatment, Care And Rehabilitation, 2014 Apr; 23(3), p. 837-48.
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Development And Validation Of The Functional Assessment Of Chronic Illness Therapy Treatment Satisfaction (facit Ts) Measures
Authors: Peipert J.D. , Beaumont J.L. , Bode R. , Cella D. , Garcia S.F. , Hahn E.A. .
Source: Quality Of Life Research : An International Journal Of Quality Of Life Aspects Of Treatment, Care And Rehabilitation, 2014 Apr; 23(3), p. 815-24.
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Have a little faith: measuring the impact of illness on positive and negative aspects of faith.
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Comparing higher order models for the EORTC QLQ-C30.
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Neuro-qol: Brief Measures Of Health-related Quality Of Life For Clinical Research In Neurology
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Source: Neurology, 2012-06-05 00:00:00.0; 78(23), p. 1860-7.
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The psychosocial impact of cancer: evidence in support of independent general positive and negative components.
Authors: Lai J.S. , Garcia S.F. , Salsman J.M. , Rosenbloom S. , Cella D. .
Source: Quality Of Life Research : An International Journal Of Quality Of Life Aspects Of Treatment, Care And Rehabilitation, 2012 Mar; 21(2), p. 195-207.
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Developing an emotional distress item bank for cancer patients.
Authors: Heinemann A.W. , Bode R.K. , Rosenbloom S. , Cella D. .
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Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients.
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Age-associated differences in fatigue among patients with cancer.
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Is Less More? A Preliminary Investigation Of The Number Of Response Categories In Self-reported Pain
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Classical test theory and item response theory/Rasch model to assess differences between patient-reported fatigue using 7-day and 4-week recall periods.
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Estimation of patient preference-based utility weights from the functional assessment of cancer therapy - general.
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Source: Value In Health : The Journal Of The International Society For Pharmacoeconomics And Outcomes Research, 2007 Jul-Aug; 10(4), p. 266-72.
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The Sf-36 Physical And Mental Health Factors Were Confirmed In Cancer And Hiv/aids Patients
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IRT health outcomes data analysis project: an overview and summary.
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A comparison of three sets of criteria for determining the presence of differential item functioning using ordinal logistic regression.
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Should health-related quality of life be measured in cancer symptom management clinical trials? Lessons learned using the functional assessment of cancer therapy.
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Item banks and their potential applications to health status assessment in diverse populations.
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Factor analysis techniques for assessing sufficient unidimensionality of cancer related fatigue.
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Expansion of a physical function item bank and development of an abbreviated form for clinical research.
Authors: Bode R.K. , Lai J.S. , Dineen K. , Heinemann A.W. , Shevrin D. , Von Roenn J. , Cella D. .
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Defining higher order dimensions of self-reported health: further evidence for a two-dimensional structure.
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Issues in the development of an item bank.
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Should symptoms be scaled for intensity, frequency, or both?
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Developing an initial physical function item bank from existing sources.
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