Current Issues in the Conceptualization and Measurement of Cancer-Related Fatigue

Transcription

1 Current Issues in the Conceptualization and Measurement of Cancer-Related Fatigue Paul Jacobsen, Ph.D. Moffitt Cancer Center Tampa, Florida June 15, 2012

2 Chief Concerns of Cancer Survivors In the past month Fears of disease recurrence 77% Energy level 57% Difficulty remembering/concentrating 43% Feeling tense or anxious 42% Difficulties with medical insurance 41% Returning to normal 40% Sexual functioning 40% Achieving life goals 39% Poor sleep 39% Feeling depressed 37% Andrykowski et al, Bone Marrow Transpl 1999;24:

3 Objectives Discuss conceptualization and presentation of cancer-related fatigue (CRF) Describe and critique current approaches to measurement of CRF Identify directions for future research

4 Defining Fatigue PATIENTS Terms used: Feel tired Feel exhausted Feel weak Feel mentally dull Feel frustrated Can t get going CLINICIANS Terms used: Tiredness Exhaustion Fatigue

5 What is Cancer-Related Fatigue? Distressing persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion Related to cancer or cancer treatment Not proportional to recent activity Interferes with usual functioning

6 Presentation of Cancer-Related Fatigue Disease symptom Initial disease symptom Symptom associated with advancing disease Acute treatment side effect Chemotherapy Radiotherapy Hormonal therapy Biological and targeted therapies Persistent symptom after treatment completion

7 Measurement of Fatigue Level of measurement Unidimensional Multidimensional Case definition

8 Recent Reviews of Measurement Approaches Unidimensional and Multidimensional Pierre et al, Oncologist 2007 (P) Minton & Stone, Ann Oncol 2009 (M) Whitehead, J Pain Symptom Manage 2009 (W) Seyidova-Khoshknabi et al, Am J Hospice Pall Med 2011 (S) Case Definition Donovan et al, Psycho-Oncol 2012

9 Unidimensional vs. Multidimensional Authors Unidimensional Other Pierre QoL subscales Minton others Multidimensional Whitehead QoL subscales Seyidova- Khoshknabi 3 37

10 Unidimensional Measures Visual Analog Scales Not tired Full of energy Totally Exhausted

11 Unidimensional Measures Numeric Rating Scales Brief Fatigue Inventory Now Usual Worst Interference (6 items) Mendoza et al, Cancer departments-programs-and-labs/departments-and-divisions/ symptom-research/symptom-assessment-tools/brief-fatigue-inventorybfi.html

12 Unidimensional Measures Multi-item Ratings FACIT-Fatigue (13 items) Not at all A little bit Somewhat I feel fatigued I feel tired I have energy I need to sleep during the day I need help doing my usual activities I have to limit my social activity because I am tired Quite a bit Very much Yellen et al, J Pain Symptom Manage

13 Unidimensional Measures Strengths Ease of administration (most) Clarity of interpretation (most) Widely used in research (some) Robust psychometric properties (some) Cut-offs for identifying clinically relevant fatigue (some)

14 Unidimensional Measures Strengths Ease of administration (most) Clarity of interpretation (most) Widely used in research (some) Robust psychometric properties (some) Cut-offs for identifying clinically relevant fatigue (some) Weaknesses Questionable reliability (single-item measures) Limited scope of assessment (several) Lack of information on symptom characteristics, perceived interference, perceived variability (several) Inconsistency with many definitions of CRF (several)

15 Multidimensional Measures Multidimensional Fatigue Inventory Smets et al, 1995 Multidimensional Fatigue Symptom Inventory-SF Stein et al, 1998 Cancer Fatigue Scale Okuyama et al, 2000 Schwartz Cancer Fatigue Scale Schwartz, 1998 General General Physical Physical Physical Physical Mental Mental Cognitive Cognitive Reduced activities Reduced motivation Emotional Affective Emotional Vigor Temporal

16 Multidimensional Measures Strengths Broader scope of measurement (most) Broader understanding of fatigue experience (most) Consistency with many definitions of CRF (several)

17 Multidimensional Measures Strengths Broader scope of measurement (most) Broader understanding of fatigue experience (most) Consistency with many definitions of CRF (several) Weaknesses Greater length (most) Limited used in research (several) Limited psychometric info or weak properties (several) Lack of consensus on dimensional structure of CRF (all) Clinical value of measuring dimensions not evident (all)

18 Unidimensional and Multidimensional Approaches Weaknesses Lack of consistency in definition of CRF Limited utility in establishing prevalence and incidence of clinically significant CRF Difficulty distinguishing CRF from other conditions

19 Diagnostic Criteria for CRF A. Six or more of the following present every day or nearly every day during same 2 weeks in the past month; At least 1 symptom is significant fatigue (#1) 1. Significant fatigue, diminished energy, increased need to rest disproportionate to any recent change in activity level 2. Generalized weakness, limb heaviness 3. Diminished concentration, attention 4. Decreased motivation, interest in usual activities 5. Insomnia or hypersomnia 6. Sleep unrefreshing or nonrestorative 7. Struggle to overcome inactivity 8. Emotional reactivity to feeling fatigued (sadness, frustration, irritability) 9. Difficulty with completing daily tasks attributed to fatigue 10. Perceived short-term memory problems 11. Postexertional malaise lasting several hours Cella et al, Oncology 1998;12(11a):369-77

20 Diagnostic Criteria for CRF B. Symptoms caused clinically significant distress or impairment in social, occupational, or other important areas of functioning C. Evidence from history, physical examination, or laboratory findings that symptoms are consequence of cancer or cancer therapy D. Symptoms not primarily consequence of co-morbid psychiatric disorders such as major depression, somatization or somatoform disorder, or delirium Cella et al, Oncology 1998;12(11a):369-77

21 First published in 1998 * Brief History Developed by members of the Fatigue Coalition Described as diagnostic criteria for cancer-related fatigue (CRF) Developed because progress toward treatment hampered by lack of consensus about definition and diagnosis * Based on clinical experience, survey results, and consensus-based discussion Accompanied by diagnostic interview guide * Cella et al, Oncology 1998

22 Case Definition Terminology Set of standard criteria used to decide if a particular disease or condition is present Used for surveillance purposes to determine prevalence of cases Used for diagnostic purposes in individual cases Clinical Syndrome Clinically recognizable features, signs, symptoms or characteristics that often occur together Used when underlying cause has not yet been discovered or when a number of different causes all give rise to same combination of signs and symptoms

23 Samples Studied First author N Sample Cella males & females, mixed cancer, post-chemo Sadler 2 51 males & females, mixed cancer, post-bmt Van Belle males & females, mixed cancer, outpatients Andrykowski females, breast cancer, off & on treatment Young 5 69 females, breast cancer, off treatment Murphy 6 16 males & females, mixed cancer, advanced Fernandes 7 25 females, mixed cancer, inpatient Alexander females, breast cancer, off treatment Andrykowski females, breast cancer, off treatment

24 Psychometric Features Inter-rater reliability (kappa =.87) 2 Internal consistency reliability A1-A11 (alpha =.82) 3 Prevalence using various sets of criteria A only: 23% 5, 25% 1, 54% 3 A and B only: 17% 1, 19% 5 A, B, and C only: 50% 6 A, B, C, D: 9% 9, 10% 4,9, 13% 9, 21% 2, 22 %9, 26% 4, 30% 8, 56% 7 Impact of differing A criteria symptoms required 1,7 A1+ B= 26%; A1+ any 5A + B= 17%; A1+ all 10A + B= 2% 1

25 Prevalence of individual symptoms 1,2,5 Symptom 1 Significant fatigue 37% Need to struggle to overcome inactivity 35% Insomnia/hypersomnia 31% Nonrestorative sleep 31% Generalized weakness 25% Trouble completing tasks due to fatigue 25% Decreased motivation 24% Marked emotional reactivity to fatigue 21% Trouble concentrating 17% Perceived short-term memory problems 17% Post-exertional malaise 17%

26 Relation to Continuous Measures Relation to measures of fatigue Greater in patients meeting criteria 2,3,4,5,8,9 VAS FSI MFSI FACT-F POMS-F SF-36 Vitality BFS EORTC-Fatigue

27 Course Course of CRF during adjuvant breast cancer treatment 4 Criteria Met Baseline No 258 (90%) Yes 30 (10%) End of tx No 198 (69%) Yes 60 (21%) No 15 (5%) Yes 15 (5%) Non-cases Incident cases Resolving cases Persistent cases Predictors of incident cases: chemotherapy, fatigue catastrophizing

28 Course Course of CRF after adjuvant breast cancer treatment 9 Assessment Prevalence Incidence N % N % End of tx 67/ / months post tx 26/ / months post tx 29/ /

29 Positive Features Small but growing evidence base (9 studies) Diagnostic interview yields reliable ratings (1 study) Items A1-A11 appear internally consistent (1 study) Significant differences in fatigue evident between patients who do and do not meet diagnostic criteria (6 studies) Meeting criteria after start of treatment (i.e., incident cases) related to known risk factors (e.g., chemotherapy administration, fatigue catastrophizing) (1 study)

30 Negative Features Creation of original criteria not based on broad evidence base or rigorous development procedures Lack of taxometric research looking at dimensional vs. categorical properties of CRF Use of the criteria by research community has been limited Criterion C (symptoms a consequence of cancer or its treatment) not always implemented (perhaps due to lack of detailed rating information) Criterion D (symptoms not primarily a consequence of co-morbid psychiatric disorder) either not implemented or implemented more strictly than proposed (perhaps due to lack of detailed rating information) Criteria not being periodically reviewed and revised (perhaps due to lack of official sponsor)

31 Future Directions Incorporate common measure (e.g., PROMIS Fatigue-SF) in new studies to facilitate cross-study comparisons

32 Future Directions Incorporate common measure (e.g., PROMIS Fatigue-SF) in new studies to facilitate cross-study comparisons Conduct studies designed to evaluate clinical utility of multidimensional approaches

33 Future Directions Incorporate common measure (e.g., PROMIS Fatigue-SF) in new studies to facilitate cross-study comparisons Conduct studies designed to evaluate clinical utility of multidimensional approaches Refine and rigorously evaluate CRF diagnostic criteria

34 Future Directions Incorporate common measure (e.g., PROMIS Fatigue-SF) in new studies to facilitate cross-study comparisons Conduct studies designed to evaluate clinical utility of multidimensional approaches Refine and rigorously evaluate CRF diagnostic criteria Identify ways to improve discriminant validity of CRF measures

35 Future Directions Incorporate common measure (e.g., PROMIS Fatigue-SF) in new studies to facilitate cross-study comparisons Conduct studies designed to evaluate clinical utility of multidimensional approaches Refine and rigorously evaluate CRF diagnostic criteria Identify ways to improve discriminant validity of CRF measures Consider role of performance-based measures in assessment of CRF

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