Using the modified Breast Cancer EDGE rating scales recommended by the APTA EDGE Task Force (Table 2 and Table 3), each of the identified measurement tools was evaluated. Those measurement tools that met all the EDGE criteria listed were rated as a “4 - Highly Recommend.” The first and second authors communicated via phone numerous times to come to agreement on the tools.
For the 22 one-dimensional CRF measurement tools identified (Table 4), only the Brief Fatigue Inventory (BFI) demonstrated excellent psychometric properties and was validated in the breast cancer population rating it as a “4 - Highly Recommend.” Further review revealed that 5 other measurement tools, including the Visual Analog Scale (VAS), the Bi-dimensional Fatigue Scale (BFS), the European Organization for Research and Treatment of Cancer-Fatigue (EORTC-F) and the Wu Cancer Fatigue Scale (WCFS), and Functional Assessment for Cancer Therapy-Fatigue (FACT-F) met the EDGE criteria for recommendation as a “3-Recommend.” These tools displayed good psychometric properties and were validated in the breast cancer population. Although there were an additional 16 assessment tools reviewed, the tools were evaluated as a “2-Unable to recommend.” Recommendation of a “2” is further subdivided into 2A and 2B. Seven measurement tools were categorized as 2B and 6 were categorized as a 2A.
Of the 21 multidimensional CRF measurement tools identified (Table 5), two measurement tools met the criteria for a rating of “4” - highly recommend. These included the Functional Assessment of Cancer Therapy-breast cancer subscale (FACT-B) scale and the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Five tools were identified as a “3-Recommend.” These include the Diagnostic Interview for Cancer Related Fatigue (DICRF), Fatigue Symptom Inventory (FSI), Medical Outcome Survey 36 item Short Form Health Survey (MOS 36-SF), Piper Fatigue Scale Revised (PFS-R), and Profile of Mood States Fatigue/Vigor/and Fatigue/Inertia Subscales (PMS/FVS/PMSI). Of the remaining 14 multidimensional tools, 9 tools were rated as a “2-Unable to recommend” while 5 tools were rated as a “1-Do not recommend.”
Although the 43 tools identified have all been used to evaluate CRF in patients diagnosed with breast cancer, few have been validated specifically for the breast cancer population. By using the strict criteria of the EDGE rating form, the list of tools that can be recommended or highly recommended is very limited. Effectiveness of the treatment of CRF and follow up of the treatment were not assessed as part of this study.
Due to the complexity of the etiology and conceptual framework of CRF, identifying appropriate evidence-based assessment tools has proven difficult. Many challenges exist in evaluating the evidence for CRF measurement tools for persons diagnosed with breast cancer including inconsistency in the definition of fatigue, measurement tools that do not always reflect the definitions, and lack of consistency in research protocol preventing comparisons of studies. There is also considerable debate regarding the usefulness and appropriateness of assessing CRF with a one-dimensional versus a multidimensional measure with advantages and disadvantages to both types of tools. “A brief measure may provide a rapid assessment or serve as screening tool; however, it may not capture all the dimensions of fatigue.”11 One-dimensional CRF measurement tools focus on screening for severity, and general impact/physical activity interference. One-dimensional scales are generally quick, easy to administer, and provide baseline criteria to begin education. However, these tools are limited by self-report style and no consideration of other etiologies potentially contributing to the fatigue. This is in stark contrast to the multidimensional measurement tools that focus assessment to include some or all of physical, emotional, cognitive, mental, behavioral, affective, temporal, sensory, and phenomenology. Multidimensional scales may not always be practical in a clinical setting because of time constraints and burden on the patients and clinicians.
Task forces and experts have collaborated together to address some of these difficult issues. The NCCN guidelines have created an algorithm for all cancer populations in screening, evaluating, and treating CRF.19 However; strict validation to persons diagnosed with breast cancer has not been completed. Butt et al stated, “a positive screening should be followed up with a more comprehensive assessment to fully explore symptom etiology and possible treatment routes. In environments with limited resources, effective screening tools hold the promise for identifying those patients who would most benefit from more thorough evaluation and in the process, identifying those patients who may be less likely to be experiencing significant symptoms.”27
The NCCN guidelines suggests, “ongoing surveillance provides an opportunity to identify long-term or persistent, moderate to severe CRF level (> 4 on scale from 0 to 10), particularly in survivors with lower pre-morbid physical function, indicating the need for a comprehensive primary fatigue evaluation and prompt referral to an appropriate rehabilitation program.”19
Despite the above guidelines and recommendations, no study has attempted to apply a rigorous evidence-based approach to the usefulness of the existing tools to assess CRF in persons diagnosed with breast cancer. Although there were 43 scales identified and assessed in this study, only three meet the criteria to be classified as “4-Highly Recommend” when using the modified EDGE form in the breast cancer population. Of these, one onedimensional CRF scale, the BFI is highly recommended. The BFI is available in 43 different languages and is easy to administer and score. This 9-item survey has shown to be internally stable with good construct (0.81- 0.92), concurrent (r = 0.84 - 0.88, P< 0.001), and discriminate validity (r = 0.34 - 0.38, P < 0.001)). In research that included patients diagnosed with breast cancer, Internal consistency was measured as Cronbach's a = .96.28 The authors were unable to find the MCID for this measurement survey. This tool is highly recommended for use as a screening tool in the clinic and for research purposes with the breast cancer population.
There are two multidimensional tools rated as a “4-Highly Recommend.” Both have been validated and used throughout many studies in the breast cancer population. The FACT-B is a 44-item self-report instrument consisting of the FACT-G (general) plus the Breast Cancer Subscale. This tool demonstrates reliability, validity, and sensitivity to change. The tool is easy to administer and score.29 In one study, the MCID was found to be ≥ 8 in the upper bound and ≥ 7 in the lower bound.30 The MFSI-SF is a 30-item survey with general, physical, emotional, mental, and vigor dimensions. The MFSI-SF was found to have internal consistency for each of the subscales in a study that included 186 patients diagnosed with breast cancer. The alpha coefficients for the 5 empirically derived subscales include 0.96 for general fatigue, 0.92 for emotional fatigue, 0.87 for physical fatigue, 0.91 for mental fatigue, and 0.90 for vigor. Divergent and convergent validity was determined through correlations with other fatigue measurement tools with r ranges = 0.21-0.82. The MFSI-SF has proven to be valid and reliable both in clinical and research setting.31,32 The ease of administration and scoring make the MFSI-SF a desirable tool, which has been tested for construct, concurrent, and convergent validity.22,31 The authors were unable to find any determination of MCID for the MFSI-SF.
Five one-dimensional tools were rated as a “3-Recommend” which merit consideration. The BFS, also known as the Chalder or the Fatigue Questionnaire, is useful as a screening tool, but has a lower specificity and positive predictive value.33 A single-item CRF measure, the VAS is simple and easy to use, and has been recommended as an initial screen for all patients diagnosed with cancer or for frequent CRF measurements. However, the VAS has only been validated in the breast cancer population in a very small study (n = 25) and requires further research.22,34 The WCFS is a 9-item measurement tool that demonstrated the psychometric criteria for a rating of “3-Recommend.” Although the WCFS has been validated in the persons diagnosed with breast cancer, this tool has been used less extensively, but may have potential for greater use.35 The FACT-F has been used with persons diagnosed with cancer but less frequently with breast cancer. The FACT-F has been shown to be a good tool to identify persons diagnosed with breast cancer at higher risk of clinically significant ongoing posttreatment fatigue, good for screening fatigue but not as useful as a diagnostic tool.13,22 The 3-item fatigue subscale has been validated in the EORTC QLQ C30 and is recommended because of its brevity and ease of administration.13 In 2003, Knobel et al stated, “However, it has been noted to have a ceiling effect in advanced cancer patients.”36
Five multidimensional studies met the criteria for a “3-Recommend” rating. “The PFS-R is one of the most developed and widely used CRF multidimensional scales.”24 However, the scale's reference point is “present time” therefore anyone assessed must be experiencing fatigue at time of assessment.36 The PFS-R is also relatively long to use in clinical settings but a recent study by Reeve et al in 2012 validated an item reduction for use in persons diagnosed with breast cancer.37-39 The FSI was validated in the persons diagnosed with breast cancer; however, data is limited with test-retest reliability.13,39-41 The rest of the psychometric properties demonstrate its clinical and -research ability.39 The MOS-36/RAND-36 energy fatigue subscale has been shown to be equivalent to the vitality score for the PFS psychometrically.42 This tool demonstrates high internal consistency, strong convergent and discriminate validity.41,42 Because of its overall multidimensional qualities, the MOS-36/RAND-36 is a comprehensive measurement tool for evaluation. The POMS-SF subscales of fatigue/inertia and vigor/activity are easy to administer and score. Reliability estimates show good internal consistency, test-retest correlations, and construct validity as well as responsiveness to changes in CRF.41-44 The DICRF is considered the most comprehensive assessment tool. However, interviews require specialist training to administer and are time consuming. After an effective screening process is completed, this tool is recommended for patients who rate a moderate to severe range on one-dimensional scales.45 Fatigue measurement tools that were unable to be recommended either did not have psychometric data available or the psychometric and/or clinical utility was poor.
Limitations to this overall study include lack of validation for some outcome measures used for persons diagnosed with breast cancer or the breast cancer specific data was unable to be separated from other participants in the study. Lack of psychometric data and quality of measurement of psychometric data limited the proper evaluation of these tools.
This study provides evidence for measurement tools appropriate to evaluate CRF in persons diagnosed with breast cancer. In choosing an evidence-based fatigue measurement tool, there are additional factors to consider such as the dimension of the fatigue to be assessed, the population that is being assessed, and the time allotted for assessment.39 Whitehead states, “The final choice of measure must represent a compromise between the detail required and the practical issues of completion.”47 The answer to these questions may guide your decision to use a onedimensional or multidimensional tool. The one-dimensional tools may be better for screening or in clinical situations, whereas the multidimensional tools will have greater utility in a research setting or patients whose screening suggests moderate to severe fatigue. Based on this study's findings, an algorithm is proposed to serve as a guide to the decision making process (Figure 1).
Many opportunities exist for future research utilizing both the one-dimensional and multidimensional measurement tools. These include validation of CRF measurement tools with persons diagnosed with breast cancer focusing on different diagnosis of breast cancer, different stages of breast cancer, a variety of time frames along the continuum of care and longitudinal studies for long-term analyses. Tools for clinic use have different requirements than those for research studies and need specific validation. Due to the complexity of the etiology of fatigue, more in depth studies looking at the hematologic and biochemical factors associated with fatigue along with self-report could strengthen the use of the tools. With the progression of technology, the validation of electronic fatigue tools would be very useful for medical records, as an application on phones and computers and thus an easy way to communicate to the health care team.
One one-dimensional (recommended for screening) and two multidimensional (recommended for evaluation/treatment) CRF measurement tools meet the criteria to be rated as a “4-Highly Recommend” for breast cancer survivors throughout the continuum of care. Five one-dimensional tools and 5 multidimensional tools meet the criteria for “3-Recommend” for use with breast cancer patients. The use of validated tools for the assessment of CRF may provide a framework for the design of studies or interventions to improve outcome measures in persons diagnosed with breast cancer.
We would like to extend our thanks to Mary Ann Wilmarth, PT, DPT, MS, OCS, MTC, CertMDT, Chief of Physical Therapy, Harvard University, for her assistance.
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Keywords:©2014 (C) Academy of Oncologic Physical Therapy, APTA
one-dimensional; multidimensional; continuum of care