University of DaytoneCommons

Physical Therapy Faculty Publications Department of Physical Therapy

4-2018

Oncology Section EDGE Task Force on Cancer:Measures of Cancer-Related Fatigue—ASystematic ReviewMary Insana FisherUniversity of Dayton, mary.fisher@udayton.edu

Claire DaviesBaptist Health Lexington, cmclaired@hotmail.com

Hannah LacyGood Samaritan Hospital

Deborah DohertyOakland Universityi, doherty@oakland.edu

Follow this and additional works at: https://ecommons.udayton.edu/dpt_fac_pub

Part of the Biomechanics Commons, Musculoskeletal System Commons, OrthopedicsCommons, and the Therapeutics Commons

This Article is brought to you for free and open access by the Department of Physical Therapy at eCommons. It has been accepted for inclusion inPhysical Therapy Faculty Publications by an authorized administrator of eCommons. For more information, please contact frice1@udayton.edu,mschlangen1@udayton.edu.

eCommons CitationFisher, Mary Insana; Davies, Claire; Lacy, Hannah; and Doherty, Deborah, "Oncology Section EDGE Task Force on Cancer: Measuresof Cancer-Related Fatigue—A Systematic Review" (2018). Physical Therapy Faculty Publications. 56.https://ecommons.udayton.edu/dpt_fac_pub/56

1

Oncology Section EDGE Task Force on Cancer: Measures of Cancer Related Fatigue –

A Systematic Review

Mary Insana Fisher, PT, PhD1 Board-certified Orthopedic Physical Therapist, Certified Lymphedema Therapist

Claire Davies, PT, PhD2 Certified Lymphedema Therapist - LANA

Hannah Lacy, PT, DPT3

Deborah Doherty, PT, PhD4

1Associate Professor, Department of Physical Therapy, University of Dayton

2Physical Therapist, Rehabilitation Services, Baptist Health, Lexington, KY

3Physical Therapist, Good Samaritan Hospital, Dayton, OH 4Associate Professor, Oakland University, Rochester, MI

Corresponding Author: Mary I. Fisher, PT, PhD

Department of Physical Therapy

University of Dayton

300 College Park

Dayton, OH 45469-2925

The authors acknowledge no conflicts of interest.

Funding for conference travel was provided to MI Fisher by the Oncology Section

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ABSTRACT:

BACKGROUND: Cancer related fatigue (CRF) is one of the most common side effects of

cancer and cancer treatment. Being able to accurately screen for and assess CRF will improve

access to and prescriptions for interventions. Valid and reliable measures to screen for and

assess CRF need to be identified. PURPOSE: To identify and recommend reliable, valid and

clinically useful tools to screen for and assess CRF among those treated for cancer. METHODS:

A systematic review of the literature was conducted to assess the published psychometric

properties and clinical feasibility of each method identified. Task Force members independently

reviewed each measure using the Cancer EDGE Rating Form. RESULTS: Review of 136

studies resulted in recommendations for 14 questionnaires. Five unidimensional and nine

multidimensional questionnaires are recommended by the Oncology EDGE Task Force.

CONCLUSION: The 10-point Numeric Rating Scale for Fatigue is best as a screening tool,

while the Multi-dimensional Fatigue Symptom Inventory is a highly recommended

multidimensional tool. Ease of screening can promote referral for interventions, while thorough

assessment drives appropriate interventions.

KEYWORDS: Psychometrics, measurement, surveys or questionnaires

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INTRODUCTION AND BACKGROUND

Cancer-Related Fatigue (CRF) is one of the most common side effects of cancer

treatment and is not specific to any cancer diagnosis, but rather impacts up to 96% of survivors at

any point along the survivorship continuum.1 Cancer-related fatigue is defined as a distressing,

persistent, subjective sense of physical, emotional and /or cognitive tiredness or exhaustion

related to cancer or its treatment that is not proportional to recent activity and interferes with

usual functioning. 2 One of the most important considerations, and one often used to assist in

diagnosis, is the criterion that CRF is not relieved by rest.2 This sense of fatigue is perceived not

only physically, but also cognitively and emotionally.3 Fatigue is reported most consistently in

those undergoing chemotherapy, whether in isolation or in conjunction with radiation, but may

persist after treatment.4,5 Research indicates that for at least a subset of patients, CRF may be a

significant issue long into survivorship, with a negative impact on quality of life (QOL).6,7

Diagnosing CRF is complicated by the multidimensional nature of the fatigue, such as

whether it is centrally or peripherally mediated,8 and that this fatigue may be secondary to other

side effects of treatment, such as anemia. Along with anemia, cancer treatments themselves,

cancer recurrence, pain, medications, sleep disturbances, psychosocial issues including

depression and anxiety, malnutrition, decreased functioning, increased proinflammatory

cytokines, and immobility are all contributing factors.9,10 Other pathophysiological

considerations for fatigue include: abnormality in growth factors, circadian rhythm modulation,

hypothalamic–pituitary–adrenal axis disruption, serotonin dysregulation, vagal afferent

activation, abnormalities of the generation of and/or use of adenosine triphosphate, and

mitochondrial biogenesis9,11,12 Despite this multifactorial causality for CRF, health care

providers must be able to screen for CRF and make appropriate referrals, including to physical

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therapist (PT)s. PTs in turn, must be able to accurately and comprehensively assess CRF to

appropriately treat this debilitating condition.

Accurate screening and assessment are dependent upon tools that demonstrate strong

psychometric properties. Ideal screening tools are simple and efficient to administer, while

assessment tools should provide a deeper understanding of the problem. The tools must be valid,

reliable, and if used as an outcome measure, sensitive to change. Following the ongoing work of

the Evidence Database to Guide Effectiveness (EDGE) task force of the Oncology Section of the

American Physical Therapy Association, a review of tools purported to screen for and assess

CRF were analyzed for the strength of their psychometric properties. The purpose of this

systematic review is to identify a core set of both screening and assessment measures that are

reliable, valid, responsive, and clinically feasible to assess CRF.

METHODS

Search Strategy

The task force conducted a systematic review of methods and tools used to screen for and assess

CRF in order to identify reliable, valid, and clinically feasible methods that are responsive to

change which measure CRF in persons diagnosed with cancer. The primary literature search took

place May, 2016 through September, 2016 using five electronic databases: Google Scholar,

PubMed/Medline, CINAHL, Embase, and PEDro. Primary search terms used included: cancer,

CRF, reliability, and validity. Search terms included: “cancer related fatigue,” “cancer-related

fatigue,” “fatigue AND cancer,” AND measures, measurements, questionnaires, AND

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psychometrics. Additional search terms for the specific clinical measuring tools are in the

Appendix. A secondary search was completed in August, 2017 to update any new evidence.

Article Selection

To be included in this review, studies (1) had to have been published in English; (2) described

tools used to screen for or assess CRF; (3) reported psychometric properties of the tools used to

screen or assess CRF; (4) presented clinically feasible methods for the screening and assessment

of CRF; (5) included the adult population (≥18); and (6) were published between January 1, 1997

– August, 2017. Excluded articles demonstrated a lack of evidence, included the pediatric

population, or were not considered to be a fatigue screening or assessment tool. This final

exclusion criterion included any scale that evaluated the impact of fatigue or CRF on health-

related QOL. If a study published prior to 1997 was deemed a key article to either explain the

measure or was foundational in establishing the psychometrics of a test, it was then included.

After retrieving all articles, the duplicates were removed. All studies were initially screened

based on title and abstract, and then on the basis of full-text.

Data Extraction and Analysis

Each article classified as either unidimensional or multidimensional according to the Breast

Cancer EDGE Task Force Outcomes: Evidence-based Cancer-related Fatigue Measurement

Tools.13 Unidimensional tools are commonly considered a fatigue-specific tool with one or a few

questions to identify the prevalence and severity of CRF while multidimensional measures often

examine the effect of CRF across several domains of patient function that may include

behavioral, cognitive, somatic, and affective. For the purposes of this review, the authors

consider unidimensional tools to be those that often serve to screen for the presence of the

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condition or assess only a single factor of fatigue, while the multidimensional tool provides a

more thorough assessment of the fatigue.

Each article was reviewed by two teams of two reviewers who independently performed

data extraction using the Cancer EDGE Task Force Rating Form (Figure 1 available online).

Psychometric properties included in the Cancer EDGE Task Force Rating Form consist of

reliability, validity, ceiling/floor effects, sensitivity to change, and clinical utility. Because CRF

tools are self-report questionnaires, the types of reliability evaluated included test-retest

reliability and internal consistency. Internal consistency examines whether the items on different

questionnaires reliably measure the same thing. The following criteria were applied to describe

the strength of the psychometric properties: excellent reliability = >0.90; good reliability = 0.76-

0.89; moderate reliability = 0.50-0.75; and poor reliability <0.50.14 Criterion and construct

validity including concurrent, divergent, discriminative, and predictive validity values are

reported when available, as well as measures assessing responsiveness to change such as

minimal detectable change (MDC) and minimal clinically important difference (MCID). Each

reviewer then rated the measure using the updated Cancer EDGE Rating Scale.15 Any

discrepancies in ratings were discussed with all four reviewers until consensus was obtained.

RESULTS

The literature search initially found 626 articles that included CRF measures. After duplicate

studies were removed and the inclusion criteria were applied, 136 articles were reviewed. See

Figure 2 for flow chart.

Five unidimensional measures and nine multi-dimensional tools are recommended for

use. Among the unidimensional CRF questionnaires, three are highly recommended (4 rating):

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Modified Brief Fatigue Inventory (mBFI); Cancer-Related Fatigue Distress Scale; and a 10-point

Rating Scale for Fatigue. Two unidimensional tools are recommended (3 rating): the MD

Anderson Symptom Inventory and Wu Cancer Fatigue Scale. Tables 1 and 2 summarize the

features and ratings for the recommended measures. Seven scales received ratings of 1 (not

recommended) or 2 (reasonable to use), and are not reviewed in detail. Table 3 lists measures

that are reasonable to use or not recommended, with summary rationale. Table 4 provides a

summary of the clinical usefulness of the recommended measures.

Only one multi-dimensional tool is highly recommended by the Cancer EDGE Task

Force and that is the Multi-dimensional Fatigue Symptom Inventory. Eight CRF measurement

tools received a recommended rating of 3: Bi-dimensional Fatigue Scale, Cancer Fatigue Scale,

Fatigue Symptoms Inventory, Multidimensional Fatigue Inventory, Piper/ Quick Piper, Profiles

of Mood States, PROMIS Cancer Fatigue Short Form, and Schwartz Cancer Fatigue Scale. See

Tables 5 (reliability and sensitivity to change) and Table 6 (validity) for details on the

psychometric properties of all recommended (rated 3 and 4) tools.

DISCUSSION

Accurate diagnosis of CRF is important to guide treatment. Researchers propose that four

criteria be considered to establish the diagnosis of CRF, including: 1) a period of two weeks or

longer within the preceding month during which significant CRF or diminished energy was

experienced each day or almost every day along with additional CRF-related symptoms; 2) the

experience of CRF resulting in significant distress or impairment of function; 3) the presence of

clinical evidence suggesting that CRF is a consequence of cancer or cancer therapy; and 4)

fatigue is not primarily a consequence of a concurrent psychiatric condition, such as major

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depression.12 Before the diagnosis of CRF is made, it is important that the results of a full

medical workup rule out other causes of fatigue such as anemia, endocrine dysfunction, or

fatigue directly related to prescription medication. The standardization and comprehensive

fatigue assessment guidelines and criteria for clinical practice developed by National

Comprehensive Cancer Network (NCCN) were developed to improve assessment and

management of CRF. This review provides evidence to consider when determining the most

valid and reliable tools to screen for and assess CRF.

This systematic review resulted in three highly recommended unidimensional tools and a

single multidimensional tool to screen for or measure CRF. These tools have strong

psychometric properties in the population of interest and can be easily used by clinicians. Several

other tools are recommended; these have good psychometric properties in the population of

interest and are clinically feasible.

Among the unidimensional tools that are either rated 3 or 4 by this task force, the use of a

10-point Rating Scale of Fatigue stands out as the most efficient method to screen for the

presence of CRF. An understanding of numeric rating scales (NRS) and visual analog scales

(VAS) is warranted when considering this tool. Numeric rating scales, where 0 = absence of a

construct and 10 = worst imaginable experience of a construct, are commonly used clinically to

assess the severity of symptoms, and most commonly used for pain assessment. The VAS, too,

is a frequently employed tool to measure severity of symptoms, and consists of a 100 mm with

markings from 0 to 10 every 10 mm along the line. In evaluating the literature, the authors found

a total of 11 studies which utilized either the NRS or the VAS in examining psychometric

qualities of instruments evaluating fatigue. Further analysis of these research studies reveals that

the term NRS is often used to mean VAS (a written expression of severity); in one case the VAS

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was converted to a NRS for telephone interviewing, yet was not identified as a NRS in study

methodology. While this overlap of terms and rating techniques results in inconsistencies in

administration, the overall intent of both methods is based on the premise of rating severity as

low to high on a 10-point scale. In the literature search completed by this task force, these 10-

point scales had multiple names: the Numeric Rating Scale for Fatigue, the Visual Analog Scale

for Fatigue, the One-Item Fatigue Scale, the Single-Item Screening Tool, and the Fatigue

Numerical Scale.

The simplicity of a 10-point Numeric Rating Scale for Fatigue make it an ideal screening

tool. The question “How would you rate your fatigue on a scale of 0 to 10 with 0 being no

fatigue and 10 being the worst possible fatigue?”, whether verbally or along a 100 mm line, is

quick and focused. This simple question captures the presence and intensity of fatigue, and

easily can be used to drive a referral for greater assessment. 2 The simplistic nature of the

question belies the strength of the psychometric properties, which demonstrate good test-retest

reliability (r=0.88) and convergent validity with the Fatigue Symptom Index, the Functional

Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), and the Multidimensional Fatigue

Inventory (general fatigue).16-18 This tool also demonstrates moderate to good sensitivity (0.70 -

0.85) and specificity (0.61 – 0.71).16,19 The NCCN Guidelines for CRF recommend a referral

with a score of four or greater.2 While the NCCN Guidelines are most frequently followed, an

empirical cut score of 5 was derived by taking into consideration an analysis of specificity and

sensitivity and based on the area under the curve (0.71).19 Given that the ease and level of

efficiency in administration is high, the a 10-point Rating Scale for Fatigue receives a highly

recommended score by the task force and is an ideal screening tool.

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Both the modified Brief Fatigue Inventory (mBFI) and the Cancer Related Fatigue

Distress Scale, while unidimensional, are more time intensive which may discourage their use to

screen for fatigue. The mBFI examines the severity and impact of fatigue on daily functioning in

the previous 24 hours through a nine-item questionnaire that can be administered via self-report,

interview, or via interactive voice recording. Each item is rated 0-10, and a global score of

fatigue is the average of all items. The mBFI has good-excellent test-retest reliability (0.89-

0.95),20 and demonstrates both construct validity with the Multidimensional Fatigue Symptom

Inventory (short form) (r=0.814)20 and concurrent validity with the FACIT-Fatigue scale (r=-

0.838-0.903).21 The Cancer Related Fatigue Distress Scale assesses the dimension of distress

related to fatigue and examines this in terms of physical, social, psychological, cognitive, and

spiritual areas. This 20-item self-report scale evaluates statements on a 0-10 scale; higher

numbers indicate greater distress.22 The Cancer Related Fatigue Distress Scale demonstrates

excellent item consistency (α=0.98), and good convergent validity with the Wu Cancer Fatigue

Scale (r=0.84), as well as good predictive validity (r=0.83).23 Understanding the impact of

fatigue and the distress experienced, can guide clinicians in treatment decisions.

The MD Anderson Symptom Inventory and the Wu Cancer Fatigue Scale, while

recommended by the task force, do not possess the strengths of psychometric properties or ease

of use that the highly recommended measures possess. The MD Anderson Symptom Inventory is

a 19-item self-report scale which examines severity and interference of CRF; higher scores

indicate greater levels of fatigue.24 This scale demonstrates acceptable levels of convergent

validity with the Brief Fatigue Inventory (r=0.84), but lower levels with the European

Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC

QLQ-30) (r=-0.60), and lacks sensitivity to change.25 The Wu Cancer Fatigue Scale scores nine

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items on a 1-5 Likert scale with higher values indicating greater fatigue.26 The internal

consistency of items is high (α=0.95),27 but the convergent, concurrent, and predictive validity

levels are lower (see Tables 5 and 6). Both are acceptable for use as they take less than 10

minutes to complete, however, the a 10-point Rating Scale for Fatigue remains a better screening

tool, and the mBFI a stronger unidimensional tool for assessing CRF.

The only highly recommended multi-dimensional fatigue tool recommended by the

Cancer EDGE task force, the Multidimensional Fatigue Symptom Inventory (Short Form),

examines fatigue in the context of global, somatic, cognitive, and behavioral manifestations

across general, physical, emotional, and mental domains.28,29 This scale, with 30 self-reported

items, takes less than 10 minutes to complete, with each item scored on a five-point Likert scale;

higher numbers indicate greater fatigue. The Multidimensional Fatigue Symptom Inventory

provides a comprehensive examination of fatigue across multiple domains with a high sensitivity

to change, an ability to discriminate not only between those with and without fatigue but among

those with differing levels of function due to fatigue,28 and demonstrates moderate to high

correlations with other established scales (Fatigue Symptom Inventory, r=0.82 and SF-36, r=-

0.82).29

The recommended multidimensional tools outlined in Table 2 are adequate alternatives

for the clinicians to comprehensively assess CRF. Each takes less than 10 minutes to complete,

and demonstrates adequate psychometric properties. The 11-item self-report Bidimensional

(Chalder) Fatigue Scale measures the extent and severity of fatigue on a four- point Likert scale

with a higher global score indicating greater fatigue, or two subscale scores (physical and

psychological).30 Specifically designed to assess CRF, the Cancer Fatigue Scale is a 15-item

self-report scale that takes approximately two minutes to complete. It examines fatigue across the

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physical, affective, and cognitive domains using a five-point Likert scale with higher scores

indicating greater fatigue.31 The Fatigue Symptom Inventory uses 14 items scored 0-10 to assess

the severity, frequency, and daily pattern of fatigue as well as how it interferes with QOL, scored

low to high either globally or by subscale.32 The Multidimensional Fatigue Inventory, a 20 item,

five-point Likert questionnaire scored inversely (higher values mean lower fatigue), measures

fatigue across general, mental, and physical domains with consideration for reduced activity and

reduced motivation.33 As one of the more well known fatigue measures, the Piper (22

items)/Quick Piper (15 items) Fatigue Scale assess fatigue across the temporal, sensory,

affective, and intensity/severity domains using a 0-10 visual analog scale with higher scores

indicating greater fatigue.34 The Profile of Mood States-2 assesses fatigue-inertia as one of the

seven mood states, using 35 items scored on a five-point Likert scale with higher values

indicating greater levels within each mood state.35 The Patient Reported Outcome Measure

Information System (PROMIS) assesses fatigue in the past week using a seven item self-report

scale, scored with a one-five Likert where higher scores indicate greater fatigue.36 And lastly,

the Schwartz Cancer Fatigue Scales, developed specifically for CRF, assesses fatigue across four

scales – physical, emotional, cognitive, temporal – through a 28 item five-point Likert self-

report, with higher scores indicating greater fatigue.37

Limitations to this review need to be noted as the clinician uses this information to

inform practice. As with all reviews, new data may become available after completion of the

literature search and are not included here. This review does not assess study quality, and it is

possible that psychometric evaluation is based on small sample sizes or studies with

methodological flaws. Lastly, while this review is intended to evaluate measures to assess CRF,

some fatigue instruments lack validation in the cancer population.

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Cancer-related fatigue remains one of the most prevalent comorbidities of a cancer

diagnosis along the survivorship continuum. As such, knowing the fatigue status of survivors is

essential in order to design appropriate and comprehensive treatment plans and to monitor

patient status and the effectiveness of those treatment programs. While this review defines

reliable, valid and clinically useful tools for use in screening for and assessing CRF, clinicians

need to consider whether the tool will be used for screening or for assessment. By combining the

findings from this investigation with patient needs, appropriate referral and intervention can

occur.

14

Legends:

Table 1: Summary of Recommended Outcome Measures - Unidimensional

Table 2: Summary of Recommended Outcome Measures – Multi-dimensional

Table 3: Summary of Outcome Measures with Cancer EDGE Ratings of 1 or 2

Table 4: Clinical Usefulness of Recommended Measures

Table 5: Psychometric properties of Recommended Measures Related to Reliability and Responsiveness

Table 6: Psychometric properties of Recommended Measures Related to Validity

Figure 1: Cancer EDGE Task Force Rating Scale (online only)

Figure 2: PRISMA Flow of literature search

Appendix: Search Terms

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Appendix: Search Terms Bidimensional Fatigue Scale Brief Fatigue Inventory Cancer Fatigue Scale Cancer Related Fatigue Distress Scale Diagnostic Interview Guide for Cancer Related Fatigue European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC) Fatigue and Functional Impact Scale Fatigue Barriers Scale Fatigue Management Barriers Questionnaire (FMBQ) Fatigue Pictogram Fatigue Scale- Children Fatigue Symptom Checklist Fatigue Symptom Inventory Four-Item Fatigue Scale Functional Assessment of Cancer Therapy General Fatigue Scale Illness Perception Questionnaire Karnofsky Performance Scale Lee Fatigue Scale MD Anderson Symptom Inventory Measuring Fatigue in Childhood Cancer Medical Outcome Study QOL Short Form 36 Memorial Symptom Assessment Scale- Short Form (MASAS-SF) Modified Brief Fatigue Inventory Multidimensional Assessment of Fatigue Multidimensional Fatigue Inventory (MFI) Multidimensional Fatigue Symptom Inventory (MFSI) One-Item Fatigue Scale PEDS QL Multidimensional Fatigue Scale Piper Fatigue Scale Play Performance Scale for Children Profile of Mood States (POMS) PROMIS Cancer Fatigue Short Form QOL for Children with Cancer Quick Piper Scale Rotterdam Symptom Checklist Schwartz Cancer Fatigue Scale Spielberger State Trait Anxiety Visual Analog Scale Wu Cancer Fatigue Scale Zung Self Rating Depression Scale

16

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26

Figure. PRISMA Flow of literature search.

# of additional records identified through other sources:

22

Records after duplicates removed

and screened for eligibility:

476

Articles excluded after

title and abstract review:

340

Full-text articles assessed for eligibility:

136

Full-text articles excluded, with

reasons (pediatric/assess

other fatigue): 77

Articles included in qualitative synthesis:

59

# of records identified through database searching:

626

Iden

tific

atio

n Sc

reen

ing

Elig

ibili

ty

Incl

uded

27

Figure 2. Cancer EDGE Rating Scale

4 Highly Recommended

The outcome measure has excellent psychometric properties (reliability and validity AND have available data to guide interpretation) in condition of interest and excellent clinical utility (≤20 min, equip in clinic, no copyright payments, easy to score); the measure is free or reasonably accessible

to a broad range of providers.

3 Recommended

The outcome measure has good psychometric properties (may lack some info about reliability, validity, responsiveness) in the population of interest and good clinical utility (>20 min, some equip, training, copyright fee); OR has excellent psychometric properties but is not free and may require access to specialized testing equipment that is beyond the means of many clinicians or clinics.

2 Reasonable to Use

Limited study in target group; the outcome measure has good or excellent psychometric properties and clinical utility in a related population, but insufficient study in target population to support higher recommendation.

1 Not Recommended The outcome measure has poor psychometric properties and/or poor clinical utility

28

Table 1

Summary of Recommended Outcome Measures - Unidimensional

Measure EDGE Rating Features

Brief Fatigue Inventory/ Modified-Brief Fatigue Inventory9,38-49 4

• Severity of fatigue in the last 24 hours

• Less than 5 minutes to complete

• Used in a cancer population

Cancer Related Fatigue Distress Scale22,26,27 4

• Assesses cancer related fatigue distress

• 10 minutes to complete • Used in a cancer population

10-point Rating Scale for Fatigue16-19 4

• Assesses the presence and intensity of fatigue

• Easy to use • Takes less than one minute to

administer • Ideal as a screening tool • Used on those with thoracic

malignancy

MD Anderson Symptom Inventory24,25,50 3

• Assesses fatigue severity over 24 hours

• Takes 2 -5 minutes to complete

• Used in cancer populations

Wu Cancer Fatigue Scale26,27 3

• 9 Item self-report • Less than 5 minutes to

complete • Used with a breast cancer

population

29

Table 2

Summary of Recommended Outcome Measures – Multi-dimensional

Measure EDGE Rating Features

Multidimensional Fatigue Symptom Inventory28,29,51,52 4

• Multiple areas assessed • Takes over 10 minutes to

administer • Used with multiple different types

of cancer

Bi-dimensional (Chalder) Fatigue Scale30,53,54 3

• Extent and severity of fatigue • Takes about 5 minutes to

complete • Used in populations of multiple

cancers

Cancer Fatigue Scale31,46,48,55,56 3

• Physical, affective, and cognitive fatigue related to cancer

• 2-3 minutes to complete • Used in a population with various

stages of cancer

Fatigue Symptom Inventory16,29,32,38,48,57-62 3

• Assesses the frequency, severity, and disruptiveness of fatigue

• Five minutes to complete (although 27% individuals reported difficulty with questionnaire)

Multidimensional Fatigue Inventory33,48,63-65 3

• Assesses fatigue in the past 24 hours

• Less than 10 minutes to complete • Used with a cancer population

Piper/Quick Piper34,48,66-75 3

• Assesses fatigue at current time • Five minutes to complete • Used in populations with breast

and lung cancer.

Profile of Mood States42,44,46,48,66,67,73,76 3

• Assesses mood over the past week

• Has a fatigue subscale • Takes 5-7 minutes to complete • Used in a population with breast

cancer Patient Reported Outcome Measure Information System (PROMIS) Cancer Fatigue Short Form36

3 • Assess fatigue over the past

seven days • Unknown time to complete

30

• Used in a population with prostate and hematologic cancer

Schwartz Cancer Fatigue Scale37,48,77 3

• Assess fatigue in the past 2-3 days

• Takes about 4 minutes to complete

• Used in a population with multiple cancers

31

Table 3

Summary of Outcome Measures with Cancer EDGE Ratings of 1 or 2

Measure EDGE Rating Strengths/Weaknesses

Four Item Fatigue Scale36,37 2 • Four questions • Lower psychometric strength

Lee Fatigue Scale60,74 2 • Not tested in cancer

population • Minimal psychometric testing

Visual Analog Scale - Fatigue52,75 2

• 18 questions on a 10 cm line • High internal reliability and

concurrent validity established • May not discriminate between

fatigue and sleepiness

Zung One Item Self-Rating Depression Scale55 2

• A depression scale validated for fatigue

• Includes a question “I get tired for no reason”.

• Possible use as a screen

Multidimensional Assessment of Fatigue60 1

• Multiple questions that take a long time to complete

• Lacks sensitivity to change

Fatigue Pictogram76,77 1

• Each response option is depicted in a picture with a generic figure together with an appropriate color. Words are written under each of the pictures as well, but no numbers are evident to the patients completing the tool.

• Lower psychometric strength

General Fatigue Scale74 1

• Measures fatigue intensity, distress levels and disruption of daily activities.

• Psychometrics not complete

32

Table 4

Clinical Usefulness of Recommended Measures

Measure Equipment Needed Cost Ease of

Use Scoring/

Interpretation Normative

Data Brief Fatigue Inventory No High Easy Easy No

Cancer Related Fatigue Distress Scale

No None Moderate Easy No

10-point Numeric Rating Scale for Fatigue

No None Easy Easy No

MD Anderson Symptom Inventory

No High Easy Easy No

Wu Cancer Fatigue Scale No None Easy Easy No

Multidimensional Fatigue Symptom Inventory

No None Easy Easy No

Bi-dimensional Fatigue Scale No none Easy Easy No

Cancer Fatigue Scale No None Easy Easy No

Fatigue Symptom Inventory

No None Easy Easy No

Multidimensional Fatigue Inventory

No None Moderate Moderate No

Piper/Quick Piper No None Easy Easy No

Profile of Mood States

No None Easy Easy Yes in

Athletes PROMIS Cancer Fatigue Short Form

No None Easy Easy No

33

Schwartz Cancer Fatigue Scale

No None Easy Easy No

Abbreviations: PROMIS: Patient Reported Outcome Measurement Information System

34

1

35

Table 5 2

Psychometric properties of Recommended Measures Related to Reliability and Responsiveness 3

Test Test-retest Reliability and Internal Consistency Responsiveness

Unidimensional Tools – Highly Recommended

Brief Fatigue Inventory (BFI)

Test-retest Reliability r = 0.90-0.9338,45,47 ICC = 0.969 Internal Consistency Inter-item correlation: ICC = 0.64 (0.46-0.81)9 Fatigue Severity Cronbach α = 0.92-9641,42,49 Functional Interference Cronbach α = 0.90-0.9541,42,49 Global Fatigue Cronbach α = 0.94-0.979,41-46

Cancer Related Fatigue Distress Scale

Internal Consistency Cronbach α = 0.95-0.9822

10-point Numeric Rating Scale for Fatigue

Test-retest Reliability r = 0.8816 ICC = 0.57 (absolute agreement)18

Diagnostic Accuracy Sensitivity = 85%16 = 70%19 Specificity

36

= 61%16 = 71%19 Area under the Curve = 0.7119 Cut Score = 42 Cut Score = 519

Unidimensional Tools – Recommended MD Anderson Symptom Inventory (MDASI) (fatigue only)

Internal Consistency Symptom Severity (fatigue included): Cronbach α = 0.85-0.8724,25

Wu Cancer Fatigue Scale

Internal Consistency: Full Scale (15 items) Cronbach α = 0.9527 Full Scale (9 items) Cronbach α = 0.9126 Physical and Emotional Subscale Cronbach α = 0.9427 Cognitive Subscale Cronbach α = 0.8627

Multidimensional Tools – Highly Recommended

Multidimensional Fatigue Symptom Inventory (MFSI)

Internal Consistency: Cronbach α = 0.83 – 0.9628,52 By subscale:29 General - Cronbach α = 0.96 Emotional - Cronbach α = 0.92 Physical - Cronbach α = 0.87 Mental - Cronbach α = 0.91

37

Vigor - Cronbach α = 0.90

Multidimensional Tools – Recommended

Bi-dimensional Fatigue Scale

Internal Consistency:30 Full scale Omega hierarchical = 0.89 Mental and physical subscales Cronbach α = 0.96

Cut score = 1153 Effect Size30 d = 1.19 (11-item) d = 1.15 (9-item)

Cancer Fatigue Scale

Test–retest Reliability: r = 0.6931 Internal consistency (15 items): Cronbach α= 0.8831

Fatigue Symptom Inventory (FSI)

Test-retest Reliability: r=0.35-0.7560 Internal Consistency: Full scale Cronbach α = 0.9432,59 Severity subscale Cronbach α = 0.8957 Interference subscale Cronbach α = 0.9157 Younger Participants Cronbach α = 0.9232 Older Participants Cronbach α= 0.9432

Effect Size:57 Severity = -0.24 Interference = -0.35 Duration = -0.09 Standardized Response Mean:57 Severity = -0.21 Interference = -0.38 Duration = -0.08 Cut score ≥3 points:62 clinically significant fatigue

38

Survivors with breast cancer Cronbach α =0.9332 Other cancer Cronbach α= 0.9432

Piper/Quick Piper (PFS)

PFS-R (22-item scale) Test-retest Reliability: Sensory Subscale r = 0.6073 Affective meaning Subscale r = 0.6873 Cognitive/mood Subscale r = 0.6373 Behavioral/severity Subscale r = 0.8173 Internal Consistency: Total Scale Cronbach α = 0.95-0.9634,73 Sensory Subscale Cronbach α = 0.89-0.9534,73 Affective meaning Subscale Cronbach α = 0.94-0.9334,73

No evidence

39

Cognitive/mood Subscale Cronbach α = 0.80-0.9234,73 Behavioral/severity Subscale Cronbach α = 0.93-0.9734,73 QuickPIPER (15-item scale) Test-retest Reliability: r = 0.94767 PFS -12 (12- item scale) Test-retest Reliability: r = 0.9268

Multidimensional Fatigue Inventory (MFI)

Internal Consistency 20 Item Scale: Cronbach α = 0.80-0.9433,63,64,81-83 15 Item Scale Cronbach α = 0.9065 Test-retest Reliability r = 0.76-0.83 total score63,65

Physical Scale Effect size = 0.4963

Profile of Mood States (POMS)

Internal Consistency: Fatigue Subscale Cronbach α = 0.9176 Vigor Subscale Cronbach α = 0.9276

Total Scale MCID = 5.677 Per each item MCID = 1.177

40

PROMIS Cancer Fatigue Short Form

Internal consistency: Cronbach α = 0.87-0.8836

Schwartz Cancer Fatigue Scale

Internal Consistency: Cronbach α = 0.9637

MCID77 Total Scale = 5.0 Increased Fatigue = 5.7 Decreased Fatigue = -2.1 Effect size = 0.71

Abbreviations: ICC = intraclass correlation coefficient; MCID: Minimal clinically important difference; r = Pearson’s r 4

5

6

7

41

Table 6 8

Psychometric properties of Recommended Measures Related to Validity 9

Criterion Validity Construct validity Concurrent Predictive Convergent Discriminant Unidimensional Tools – Highly Recommended Brief Fatigue Inventory (BFI)

With Vitality Subscale SF36: r= -0.67 (-0.73 to -0.59)9 With FFIS: r= 0.8235 With the Four Item Fatigue Screen: Spearman rho = 0.69-0.73 (0.50-0.90)36,37 BFI Worst Fatigue38 with MSAS-SF: r = 0.67 with FACIT-F: r = -0.71 BFI Usual Fatigue38 with MSAS-SF: r = 0.68 with FACIT-F: r = -0.75 BFI Current Fatigue38 with MSAS-SF: r = 0.60 with FACIT-F: r = -0.69 BFI Global Fatigue38 with MSAS-SF: r=0.72 with FACIT-F: r=-0.77

Unidimensionality: 68% of the variance explained by one factor9 BFI Single Factor Loading = 0.80-0.9439,41 BFI Worst Fatigue39 with POMS fatigue: r = 0.82 with POMS vigor: r = -0.69 BFI Fatigue Severity39 with POMS fatigue: r = 0.87 with POMS vigor: r = -0.71

With ECOG: (p<0.001)9 Between high, low KPS39 p<0.001 With in-, outpatients39 p<0.01

Cancer Related Fatigue Distress Scale

Content Validity Index = 0.60-1.00 (mean 0.91)19

Single factor loading = 0.59-0.9119

42

One Item Fatigue Scale

With FSI Severity Subscale: Spearman’s rho = 0.8716 With FACIT-F: Spearman’s rho = -0.7516 With HADS Depression subscale: Spearman’s rho = 0.5616

With, without fatigue: ROC AUC = 0.8716

Unidimensional Tools – Recommended MD Anderson Symptom Inventory (MDASI)

With EORTC QLQ-C30: r = -0.6022 With BFI Worst Pain R = 0.8422

General Symptoms factor loading >0.347 Fatigue factor loading = 0.68-0.8321,47

Between poor and good functional status: p<0.0121,47

Wu Cancer Fatigue Scale (WCFS)

With GDS r = 0.60-0.6123,24

With CRFDS r = 0.73-0.8323,24

With SCFS: r = 0.78-0.8423,24 With GDS fatigue: r = 0.59-0.6823,24 Single factor item analysis: r = 0.65-0.8624

Multidimensional Tools – Highly Recommended Multidimensional Fatigue Symptom Inventory – SF (MFSI- SF)

With POMS-fatigue: r = 0.63 – 0.8925 With SF-36 (vitality): r = 0.46 – 0.8025

Confirmatory factor analysis: 45.2 - 61.15% (four factors)25,49; With comparable fit index: 0.9026

Between individuals with cancer and healthy controls: p <0.00149 p <0.0525

43

With BDI: r = 0.6849 With SF-36 – vitality: r = -0.62-0.7825,49 With STAI: r = 0.51 – 0.8025 With CES-D r = 0.63 - 0.8025 With FSI: r = 0.7426 With HADS – depression: r = 0.77548 With HADS – anxiety r = 0.70148 Divergent validity: With MC-20: r = -0.20 to -0.3025

Between different ECOG Performance Status: p <0.0525

Multidimensional Tools – Recommended Bi-dimensional Fatigue Scale

Predictive Validity:50 Sensitivity = 92% Specificity = 53% PPV = 46% NPV = 94%

HADS – depression: r = 0.4027 HADS – anxiety: r = 0.3727 WSAS: r = 0.3627 MFIS:

44

r = 0.2427

Cancer Fatigue Scale (CFS)

With FNS: r = 0.4450

Factor analysis28 physical fatigue: 0.77-0.86 cognitive fatigue: 0.78-0.82 affective fatigue: 0.73-0.81 With VAS for fatigue: r = 0.6728 With SCFR-r: r = 0.6256 With FSI: r = 0.6256 Divergent validity with hope: r = - 0.21 to -0.2556

Between severe and moderate levels of fatigue: p<0.00152 Extent of disease: p=0.02852 Type of treatment: p < 0.0552 Between having/not having a caregiver: p = 0.00152 Between high and low function: p = 0.02956 Between 3 levels of depression: p <0.000156

Fatigue Symptom Inventory

With SF36 vitality scale: r = -0.68 to -0.7754 With the FFIS: r = 0.8035 With ZSDS: r = 0.41 - 0.7155 With MFSI-SF total: r =0.7426

Intensity with POMS-F: r = 0.65 – 0.7557 Duration with POMS-F: r = 0.64 – 0.7157 Interference with POMS-F: r = 0.7857

Between active, 1 year, and >1 year post treatment:29 Intensity (avg fatigue): p <0.05 Duration: p <0.05 Interference: p <0.01

45

Severity scale with One-Item Fatigue Screen: r = 0.8716 With CES-D: r = 0.37-0.6329 With SLDS-C r = -0.46 to -0.6129

Multidimensional Fatigue Inventory (MFI)

With the POMS-fatigue: r = 0.6862 With POMS-vigor: r = -0.72 to -0.7460,62 With HADS-Depression: r = 0.65 – 0.7761,62 With HADS-Anxiety: r = 0.41 – 0.5130,62 With Quality of Life: r = -0.6762

With NRS-fatigue Spearman’s rho = 0.5780 With VAS-general fatigue: r = 0.77 – 0.8360,82 With EORTC QLQ-3080 Spearman’s rho = 0.53 Multidimensional Scale: -confirmed via confirmatory factor analysis with comparative fit index = 0.88280 -confirmed via adjusted goodness of fit >0.90.61 With POMS-Anxiety: r = 040 - 0.4660,62 With POMS-Depression: r = 0.37 – 0.4660,62 With SF-36: r = 0.-49 to -0.6581 With STAI:

Between different fatigue levels/groups: p<0.00161,81

46

r = 0.50 – 0.6281

Piper/Quick Piper (PFS)

With POMS-fatigue: r = 0.50 to 0.8063,64,70 With POMS-vigor: r = -0.13 to -0.4463,64,70 QuickPiper with R-PFS: r = 0.9864 With MDFI: r = 0.56 - 0.7668

ROC AUC 0.74364 QuickPiper Factor analyses >0.6064 With MFI: r = 0.60 – 0.8467 With RSCL: r = 0.54 – 0.7467 With BDI: r = 0.5569 With KPS: r = -0.2969

Between lung/breast cancer patients with different fatigue levels: p>0.00167 Between active chemotherapy and no treatment: p>0.00167

Profile of Mood States (POMS)

With BFI: r = 0.8441

POMS-fatigue = 83% of total variance60 With LFS – fatigue: r = 0.5360 With LFS – energy: r = -0.3560 With MFI: r = - 0.4160

PROMIS Cancer Fatigue Short Form

With FSI – Severity: r = 0.72 – 0.7833 With CES-D:33 r = 0.51 – 0.56 With STAI: r = 0.4533 With SF-36 – vitality:

Goodness of fit: CFI = 0.9433

47

r = -0.66 to -0.7733 Schwartz Cancer Fatigue Scale

Factor analysis = 70% of total variance34 Content validity was achieved on 4 words; “listless”, “tired”, “barely able to move” and “dragged-out”.34 With CFS: r = 0.6256 With FSI: r = 0.6856 Divergent with Hope: r = -0.1656

Between good and poor function on KPS: p=0.00256 Between depression/no depression on HADS: p<0.00156

Abbreviations: BDI: Beck Depression Inventory; BFI: Brief Fatigue Inventory; CES-D: Center for Epidemiological Studies-Depression Scale; CFS: Cancer Fatigue Scale; CRFDS: 10 Cancer Related Fatigue Distress Scale; ECOG: Eastern Cooperative Oncology Group; EORTC QLQ-30: European Organisation for Research and Treatment of Cancer Quality of Life 11 Questionnaire 30; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F: Functional Assessment of Chronic Illness Therapy – Fatigue; FFIS: Fatigue and 12 Functional Impact Scale; FNS: Fatigue Numerical Scale; FSI: Fatigue Symptom Inventory; GDS: Geriatric Depression Scale; HADS: Hospital Anxiety and Depression Scale; KPS: 13 Karnofsky Performance Score; LFS: Lee Fatigue Scale; MC-20: Marlon-Crowne Desirability Scale; MDASI: MD Anderson Symptom Inventory; MFI: Multi-dimensional Fatigue 14 Inventory; MFIS: Modified Fatigue Impact Scale; MFSI-20: Multidimensional Fatigue Symptom Inventory; MSAS-SF: Memorial Symptom Assessment Scale Short Form; NRS-Fatigue: 15 Numerical Rating Scale-Fatigue; PFS: Piper Fatigue Scale; POMS: Profile of Mood States; RSL: Rotterdam Symptom Checklist; SCFR-r: Schwartz Cancer Fatigue Scale – revised; 16 SCFS: Schwartz Cancer Fatigue Scale; SF-36: Medical Outcomes Questionnaire Short Form; SLDS-C: Satisfaction with Life Domains Scale for Cancer; STAI: State Trait Anxiety 17 Index; VAS: Visual Analog Scale; WCFS: Wu Cancer Fatigue Scale; WSAS: Work and Social Adjustment Scale; ZSDS: Zung Self-Rating Depression Scale 18

Other Abbreviations: CFI: Confirmatory Factor Analysis; NPV: negative predictive value; PPV: positive predictive value; r = Pearson’s r; ROC AUC: Receiver Operator Characteristic 19 Curve, Area Under the Curve 20

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Appendix: Search Terms 22 23 Bidimensional Fatigue Scale 24 Brief Fatigue Inventory 25 Cancer Fatigue Scale 26 Cancer Related Fatigue Distress Scale 27 Diagnostic Interview Guide for Cancer Related Fatigue 28 European Organization for Research and Treatment of Cancer Quality of Life 29 Questionnaire (EORTC) 30 Fatigue and Functional Impact Scale 31 Fatigue Barriers Scale 32 Fatigue Management Barriers Questionnaire (FMBQ) 33 Fatigue Pictogram 34 Fatigue Scale- Children 35 Fatigue Symptom Checklist 36 Fatigue Symptom Inventory 37 Four-Item Fatigue Scale 38 Functional Assessment of Cancer Therapy 39 General Fatigue Scale 40 Illness Perception Questionnaire 41 Karnofsky Performance Scale 42 Lee Fatigue Scale 43 MD Anderson Symptom Inventory 44 Measuring Fatigue in Childhood Cancer 45 Medical Outcome Study QOL Short Form 36 46 Memorial Symptom Assessment Scale- Short Form (MASAS-SF) 47 Modified Brief Fatigue Inventory 48 Multidimensional Assessment of Fatigue 49 Multidimensional Fatigue Inventory (MFI) 50 Multidimensional Fatigue Symptom Inventory (MFSI) 51 One-Item Fatigue Scale 52 PEDS QL Multidimensional Fatigue Scale 53 Piper Fatigue Scale 54 Play Performance Scale for Children 55 Profile of Mood States (POMS) 56 PROMIS Cancer Fatigue Short Form 57 QOL for Children with Cancer 58 Quick Piper Scale 59 Rotterdam Symptom Checklist 60 Schwartz Cancer Fatigue Scale 61 Spielberger State Trait Anxiety 62 Visual Analog Scale 63 Wu Cancer Fatigue Scale 64 Zung Self Rating Depression Scale 65

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