Breast cancer is the most common cancer affecting women in the United States, with an estimated 232,670 new cases in 2014.1 In 2013, there were more than 2.8 million women with a history of breast cancer in the U.S., including women currently being treated and those who had completed their treatment.2 Although the medical treatment of breast cancer has improved significantly, breast cancer and its treatment continue to be associated with many undesirable symptoms and side effects.3 One such late effect is a decrease in health-related quality of life (HRQOL).4
Quality of life (QOL) is a broad multidimensional concept that includes subjective evaluations of both positive and negative aspects of life.5 The World Health Organization defines QOL as “individuals' perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment.”6 What makes HRQOL challenging to measure is that, although the term “quality of life” has meaning for nearly everyone and every academic discipline, individuals and groups can define it differently.7 Additionally, the concept of HRQOL and its elements have evolved since the 1980s to encompass those aspects of overall quality of life that can be clearly shown to affect health—either physical or mental.7-10 On the individual level, this includes physical and mental health perceptions and their correlates—including health risks and conditions, functional status, social support, and socioeconomic status. On the community level, HRQOL includes resources, conditions, policies, and practices that influence a population's health perceptions and functional status. For the purpose of this EDGE Task Force review, we defined HRQOL as perceived physical and mental health and function over time.7
The American Physical Therapy Association's (APTA) Evaluation Database to Guide Effectiveness (EDGE) Task Force was formed within the Section on Research in 2006. The Task Force's goal was to provide physical therapy professionals with a comprehensive list of outcome measures that can be administered to a specific patient population. The psychometric properties and clinical utility within a particular patient population were detailed with the ultimate goal of creating a central location for physical therapy professionals to have access to this valuable information for implementing evidence-based practice.11 The Task Force was expanded to include members from several other Sections of the APTA. After the success of the Neurology Section's StrokEDGE Task Force, where 57 outcome measures were assessed in patients with stroke, the Oncology Section created a Task Force with a focus on Breast Cancer Outcomes. The first assessment of breast cancer outcome tools from the Oncology Section Task Force targeted scapula, shoulder and glenohumeral impairments, and shoulder function and resulted in successful dissemination of the results at the APTA Combined Sections Meeting in Chicago 2012, as well as 4 publications in the 2013 Rehabilitation Oncology Journal.11-14 Succeeding assessments from the Task Force have targeted pain, lymphedema, and fatigue, and resulted in successful dissemination of the results at the APTA Combined Sections Meeting in San Diego 2013, as well as 3 publications in the 2014 Rehabilitation Oncology journal.15-17 More recently, the Breast Cancer EDGE Task Force has continued to assess breast cancer outcome measures with a focus on quality of life, strength, and endurance.
Health related quality of life has been extensively studied in the breast cancer population with a variety of patient-reported outcome measures. Women surviving breast cancer, commonly referred to as breast cancer surivors (BCS), have been found to experience psychosocial distress and physical symptoms that adversely affect their HRQOL.18 Different breast cancer treatments have been found to have varying effects on HRQOL outcomes.19 Additionally, HRQOL has been shown to be a predictor of survival for some BCS.19 Because of the effect breast cancer treatments have on HRQOL, as well as the variety of patientreported outcome measures that have been administered, there is a need to identify and decipher the quality of these measures. The purpose of this review is to identify and evaluate evidence-based measures for assessing HRQOL in BCS using the methodology of the EDGE Task Force and to make recommendations for use of these tools both in research and in the clinic.
A primary search was performed in MEDLINE on July 10, 2013 to identify publications in which HRQOL in BCS was assessed. This search resulted in the retrieval of 840 publications. The search strategy used the following search terms: (“Quality of Life”/ OR quality of life.mp. OR Dartmouth Primary Care Cooperative Information Project Functional Assessment Chart*. mp. OR COOP Chart.mp. OR Duke Health Profile.mp. OR Short Form 36 Item Health Survey.mp. OR SF-36.mp. or Katz Index of Independence in Activities of Daily Living.mp. OR Katz ADL. mp. OR Lawton Instrumental Activities of Daily Living Scale. mp. OR Lawton IADL.mp. OR Karnofsky Performance Status. mp. OR KPS.mp. OR Health Utilities Index.mp. OR HUI.mp. OR QLQ.mp. or QLS.mp. OR W-QLI.mp. OR Q-LES-Q.mp. OR QLI.mp. OR WHOQOL-100.mp. OR WHOQOL-BREF.mp. OR Spitzer QL-Index.mp. OR Cancer Rehabilitation Evaluation System.mp. OR CARES.mp. OR CARES-SF.mp. OR Functional Assessment of Cancer Therapy.mp. or FACT-B.mp. OR FACT-B+4.mp. OR QLQ-BR23.mp. OR QLQ-c30.mp.) and (((breast carcinoma.mp. OR exp Breast Neoplasms/ OR (exp Breast/ and exp Carcinoma/)) and (exp Radiotherapy/ OR exp Radiation Injuries/ OR exp Mastectomy/ OR exp Lymph Node Excision/OR exp Combined Modality Therapy/ OR exp Mammaplasty/ OR exp Sentinel Lymph Node Biopsy/)) OR exp Breast Neoplasms/dt, pc, ra, rh, su, th or (exp Breast/ and exp Carcinoma/dt, pc, rt, rh, su, th)) and (exp “Sensitivity and Specificity”/ OR exp Evaluation Studies as Topic/ OR exp “reproducibility of results”/). An English language limit was applied to this search, and there was no restriction on year of publication.
A second systematic search was performed in PsychINFO® on August 10, 2013 and yielded 846 publications. The following search terms were used: (Dartmouth Primary Care Cooperative Information Project Functional Assessment Chart* OR COOP Chart* OR Duke Health Profile* OR short Form 36 Item Health Survey OR SF-36 OR Katz.Index of Independence in Activities of Daily Living OR Katz AOL OR Lawton Instrumental Activities of Daily Living Scale OR Lawton IADL OR Karnofsky Performance Status OR KPS OR Health Utilities Index OR HUI OR QLQ OR QLS OR W-QLI OR Q-LES-Q OR QLI OR WHOQOL-100 OR WHOQOL-BREF OR Spitzer QL-lndex OR Cancer Rehabilitation Evaluation System OR CARES-SF OR Functional Assessment of Cancer Therapy OR FACT-B OR FACT-B+4 OR QLQ-BR 23 OR QLQ-c30 OR DE “Quality of Life” OR DE “Quality of Work Life” OR quality of life) AND (DE “Test Reliability” OR DE “Test Construction” OR DE “Error of Measurement” OR DE “lnterrater Reliability” OR DE “Test Standardization” OR DE “Test Validity” OR DE “Test Interpretation” OR DE “Evaluation Criteria”) AND (DE “Breast Neoplasms” OR DE “Mastectomy” OR breast carcinoma*). The results from these two searches were combined and 279 duplicate articles were removed. This left 1,407 articles that included use of an outcome measure to assess HRQOL or a component of HRQOL in a breast cancer population for our review (Figure 1).
The list of 1,407 publications was divided amongst the three reviewers (SH, SM, DE). The titles, abstracts, and methods section (when necessary) of each article were reviewed to identify outcome measures that were used to assess HRQOL in BCS. Additionally, reference lists from these publications were appraised to identify any other potential publications that should be included in the review. When indicated, full articles were obtained for review. A total of 48 outcome measures were identified from these publications. After further review of these measures, several (n = 27) were excluded as they were not designed to assess the multidimensional nature of HRQOL as defined above.
Multiple conference calls were held to generate a comprehensive list of HRQOL measures for full review. Based upon the above criteria, the reviewers agreed upon 21 HRQOL measures. These measures were divided amongst the reviewers and each reviewer was responsible for conducting a primary review of the psychometric properties and clinical utility of their assigned measures. The Cancer EDGE Task Force Outcome Measure Rating Form (Appendix A) was used to guide the primary review for each QOL outcome measure. Once each reviewer completed their primary reviews, the list was redistributed and a different reviewer performed a secondary review. Additional conference calls were held to discuss the primary and secondary reviews. In cases of disagreement, additional deliberations were performed until a group consensus was reached whether or not the measure could be recommended for clinical use using Breast Cancer EDGE Rating Scale (Table 1).
After a comprehensive review of the breast cancer literature, twenty-one different measures of HRQOL were identified for inclusion in this review. Outcome measures were excluded from this review if the focus was only on a unidimensional aspect (ie, mental health) of HRQOL such as the Hospital Anxiety and Depression scale. Another example of an outcome measure excluded was the Piper Fatigue Scale. Although aspects of HRQOL are addressed in this scale, the scale is specific to fatigue and does not meet the specific definition of HRQOL as defined by this taskforce. Additionally, measures were excluded if the focus was solely on determining Quality Adjusted Life Years (QALY). Although every effort was made to use the most appropriate search terms, because HRQOL has a variety of definitions, several measures such as the Functional Assessment of Cancer Therapy - Lung (FACT-L) and FACT-Taxane were excluded because they were not general in nature and/or related to breast cancer.
Of the 21 measures reviewed (Table 2), 11 were given the highest rating of 4 (highly recommend) and are recommended for clinical use (Table 3). These measures include: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) - Breast 23, BREAST-Q, Functional Assessment of Cancer Therapy-Breast (FACT-B), FACT-B+4 (for patients with lymphedema), EORTC QLQ - Core Questionnaire (C30), FACT-G (general), Functional Living Index-Cancer (FLIC), Ferrans and Powers Quality of Life Index-Cancer Version (QLI-CV), Psychological Adjustment to Illness Scale (PAIS), World Health Organization Quality of Life (WHOQOL-100), and SF-Health Surveys. We were unable to recommend the following nine measures due to a lack of reported psychometrics: Breast Cancer Questionnaire (BCQ), Cancer Rehabilitation Evaluation System (CARES), European Quality of Life (EQ-5D), Long-term Quality of Life-Breast Cancer (LTQOL-BC), Quality of Well-being Scale (QWB), Quality of Life - Cancer Survivors (QOL-CS) /Quality of Life - Breast Cancer (QOL-BC), Rotterdam Symptom Checklist (RSCL), Sickness Impact Profile (SIP), and Quality of Life Assessment of Cancer Patients Receiving Chemotherapy (QOL-ACD). We do not recommend the use of the Brief Cancer Impact Assessment (BCIA) because of a lack of reported psychometrics and its limited availability.
Eleven measures received the highest score possible (4) on the rating scale and are therefore favorably recommended by the reviewers. In comparison with the other outcome measures reviewed by the Oncology Section EDGE Task Force on Breast Cancer Outcomes such as pain and shoulder function,12,16 HRQOL has been more extensively studied in the breast cancer population. The rating scale used by the taskforce uses a rating of “4” to represent recommended outcome measures used in breast cancer and a “3” to represent recommended measures that have not been used in this population. All 21 of the measures reviewed were used to assess HRQOL in BCS. Therefore, the measures included in this review could only receive a score of “4,”“2A,” or “1.” Although 11 measures are highly recommended, only 4 of those tools were specifically designed for and validated in the breast cancer population. These measures include the EORTC QLQ-B23, BREAST-Q, FACT-B, and FACT-B+4. The additional 7 measures that are highly recommended also demonstrate excellent psychometric properties and good clinical utility, but they were not specifically designed with BCS in mind.
Breast Cancer Specific HRQOL Measures
The EORTC QLQ-B23 is a 23-item breast cancer specific measure that evaluates body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects. It is intended to be used with the EORTC core questionnaire (QLQ-C30) in order to comprehensively assess HRQOL in BCS.20 This measure has demonstrated good reliability (α = 0.70 - 0.91),21 validity,22 and sensitivity to change (minimally important difference (MID) = 5-10)22 and has been used in more than 10 studies involving women with breast cancer to evaluate the effects of various cancer treatments,23-27 exercise interventions and alternative medicine28-30 on HRQOL in BCS, and to assess response time to shifts in HRQOL in BCS.31 According to the developers of this tool, the EORTC QLQ-B23 should take patients approximately 10-15 minutes to complete via paper and pencil. Scoring can be complex and requires a user's agreement in order to receive the scoring manual.32
The BREAST-Q was designed to assess the effect of different types of breast surgery, on HRQOL. This tool measures both HRQOL and patient satisfaction before and after surgery. There are 5 modules, but for women undergoing surgery for breast cancer, the developers of the BREAST-Q recommend administering either the breast conserving surgery module or the mastectomy/postmastectomy reconstruction module. The BREAST-Q demonstrates good reliability (α = 0.81 - 0.98, ICC = 0.85 - 0.98) and validity although procedure specific scales require further evaluation.33 The minimal important difference has been reported as 5 points in the reconstruction module.22 According to the authors of the tool, further responsiveness data is under investigation for the other modules. The BREAST-Q has been used in at least 5 studies involving women with breast cancer. This outcome measure takes approximately 8 to 12 minutes to complete and requires the use of a free, web-based software program to finalize the scores.
The FACT-B is one of the most widely used of the Task Force's highly recommended measures to assess HRQOL in BCS.34 It is a self-report measure that encompasses physical, social, emotional, and functional well-being via the 27-item FACT-G, as well as issues related specifically to persons coping with breast cancer via the 9-item Breast Cancer subscale. The FACT-B demonstrates good reliability (ICC = 0.85), validity (convergent validity, r = 0.87 with FLIC; known-groups validity, P < 0.001)34 and sensitivity to change (MID = 7-8 points).35 To date, researchers have used the FACT-B in over 40 studies to perform cross-cultural analysis of quality of life in BCS;36,37 to evaluate various forms of exercise, psychosocial support and alternative medicine on HRQOL in BCS;38-54 to assess the impact of different cancer treatment options on QOL;55-62 to assess HRQOL both during and after treatment in BCS with various backgrounds and prognoses;63-72 and to assess HRQOL in patients with lymphedema.73-75 This outcome measure takes approximately 8 to 13 minutes to complete via paper and pencil. Individual subscale scores and total scores can be calculated by using the simple formulas provided by the tools' creators. Overall, the FACT-B appears to have good clinical utility and excellent psychometric properties.
The FACT-B+4 is comprised of the standard FACT-B plus a 4-item Arm Morbidity subscale to assess the impact of lymphedema on HRQOL in BCS.76 Like the FACT-B, it also demonstrates good reliability (α = 0.88, ICC = 0.97), validity (knowngroups validity, p = 0.018), and sensitivity to change (pre-op to post-op changes in scale scores, p = 0.01) although no values for MID exist for the Arm Morbidity subscale specifically.76 The FACT-B+4 has been used in at least 10 studies to assess HRQOL in postoperative breast cancer patients and in patients undergoing treatment for upper extremity lymphedema.55,66-68,74,77-80
General Cancer HRQOL Measures
Four other highly recommended measures (EORTC QLQ-C30, FACT-G, FLIC, and QLI-CV) were developed to evaluate HRQOL in patients with cancer. Although not developed specifically for persons with breast cancer, they all have acceptable levels of reliability and validity in this population.81-86 The EORTC QLQ-C30 and the FACT-G are both general cancer outcome measures used in several studies that have breast cancer modules that can be added to enhance the value of HRQOL assessment.81 The EORTC QLQ-C30 is a 30-item brief core measure for general use with cancer patients. The EORTC QLQ-C30 has demonstrated good test-retest reliability (r = 0.63 - 0.91),87,88 validity, and sensitivity to change (change in any scale of ≥10 points)89, and takes approximately 11 minutes to complete.90 The reviewers recommend that the EORTC QLQ-B23 always be used with the EORTC QLQ-C30 to assess HRQOL in women diagnosed with breast cancer.The FACT-G is a 27-item self-report measure that takes approximately 5-10 minutes to complete. It is both valid (convergent validity with FLIC, r = 0.79)81 and reliable (ICC = 0.92, α = 0.88)81,85 and demonstrates excellent responsiveness (MID = 3-7 points).91 The FACT-G and the FACT-B can both be useful tools depending on the specific outcomes desired in the clinic or in a particular research study. For example, normative values for both the general population and for cancer patients are available for the FACT-G, which would allow researchers to make interesting comparisons using this tool. Many studies have used the FACT-G alone to assess QOL in BCS; however, use of the FACT-B might be a better option for clinicians as it includes many breast cancer specific items.
The FLIC is a 22-item questionnaire with five subscales: physical functioning, psychological functioning, current wellbeing, gastrointestinal symptoms, and social functioning.92 This measure has been widely used with cancer patients of varying disease types and severity and in people with diverse cultural backgrounds. Validity has been reported in the breast cancer population (convergent correlations exceeding divergent correlations between FLIC subscales and SF-36 subscales, p < 0.05 for physical functioning, mental functioning, and social functioning).86 The tool has also been recently scrutinized for reliability (RT = 0.810, RA = 0.75 after 2 measurements, RA = 0.85 after 4 measurements).83 More than 10 studies have used the FLIC to assess QOL in a variety of breast cancer patients including women 2 to 5 years post adjuvant cytotoxic and/or hormonal therapy,93 women with advanced breast cancer,94 women with a wide range of time (1 - ≥10 years) since breast cancer diagnosis95 and women three weeks after initial breast cancer diagnosis.96
The QLI-CV assesses 4 domains of QOL that have been deemed highly relevant for long-term survivors of breast cancer: health and functioning, social and economic, psychological/spiritual, and family.97-99 The QLI-CV takes approximately 10 minutes to complete as respondents' rate their satisfaction on each of the 33 items. Unique to this measure is the fact that each of those items are then weighted by the respondents' assessment of the importance of each item. The QLI-CV demonstrates good validity (known-groups validity, p = 0.002 for pain, p < 0.0001 for depression and stress)98 and reliability (α = 0.95),97 and it has been used extensively in clinical research, but further examination on responsiveness would greatly enhance the clinical utility of this tool.
General HRQOL Measures
The final 3 measures are highly recommended HRQOL measures designed for the general population. They are the PAIS/PAIS-SR, WHOQOL-100, and the SF Health Surveys (SF-36/SF-36v2, SF-12/SF-12v2, SF-8). All of these tools demonstrate acceptable reliability and validity, and have also been validated in the breast cancer population.100-106 The PAIS (interview format) and PAIS-SR (self-report format) appear to be useful in assessing adjustment to illness in BCS. The PAIS is a 47-item measure of QOL and adjustment to illness across 7 domains: health care orientation, vocational environment, domestic environment, sexual relationships, extended family relationships, social environment, and psychological distress. It has been used extensively in the literature, demonstrates good validity (convergent validity, r = 0.05-0.71)103 and reliability (α = 0.86)104 but has limited responsiveness data.
The WHOQOL-100 was designed for use in patients with different disease types, varying severity of illness, age, cultural subgroups, and diverse socioeconomic backgrounds. It consists of 100 questions for 6 domains of QOL: physical health, psychological, level of independence, social relations, environment, and spirituality/religion/personal beliefs. The WHOQOL-100 has demonstrated reliability (α = 0.82 - 0.91 across domains, ICC = 0.83)106 and adequate construct, convergent, and discriminant validity across different countries for many different patient populations105,106 and it has been used in at least three studies involving women with breast cancer.105,107,108
The SF Health Surveys are widely used assessments of HRQOL.100-102 These surveys are generic measures of QOL across 8 domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The number of items is reflected in the survey title. The SF-36 has been used in more than 20 studies since 2012 to evaluate QOL in breast cancer patients. The SF-12v2 appears to be replacing the SF-36 as the instrument of choice due to decreased respondent burden (2-3 minutes to complete the SF-12v2 versus 8-10 minutes to complete the SF-36) and solid psychometric properties.100 The SF-8 also demonstrates acceptable reliability and validity.101 These measures display good clinical utility with U.S. general adult population normative data available for all measures and normative values for cancer available for the SF-12v2 (Ware 2007, 2001, 2002). Sensitivity to change values have been calculated for each subscale of the SF-36 (MCID = 3-5 points).109 Overall, the SF Health surveys are highly recommended although specific validation in the breast cancer population would further enhance the usefulness of this tool.
The reviewers were unable to recommend 9 of the reviewed outcome measures at this time. Three of these measures, the EQ-5D, QWB, and SIP are generic measures of QOL that have been briefly used with BCS in the literature but have not been validated for use in the breast cancer population. While the EQ-5D and QWB are simple measures of HRQOL, the SIP measures change in behavior as a result of illness. The QWB is also used as the standardized instrument to determine Quality Adjusted Life Years (QALY), a unit that adjusts life expectancy for diminished QOL. Because of lack of psychometric properties and validation in breast cancer, the reviewers are unable to recommend the EQ-5D, QWB, and SIP at this time.
The remaining 6 outcome measures have all been developed for use with cancer patients. Both the BCQ and the QOL-ACD were developed for use in cancer patients who are currently receiving chemotherapy. A major limitation of both is that not all patients with breast cancer will receive chemotherapy interventions. Both measures also lack responsiveness data to assist clinicians with individual patient decision-making. The QOL-CS and QOL-BC was developed for use in long-term cancer survivors. Both tools lack responsiveness data. Although the QOL-BC (breast cancer) was developed for use in the breast cancer population, the reviewers were unable to find any studies that assess its psychometric properties. The LTQOL-BC is a relatively new outcome measure designed to assess QOL in long-term survivors of breast cancer. However, the researchers were unable to find studies other than the initial developmental study that used this measure in a clinical research. The CARES is a QOL tool specifically designed for the cancer population, but the respondent burden (139 items taking up to 34 minutes to complete), complexity of scoring, and lack of use in clinical research make it difficult to recommend at this time.110 Finally, the RSCL was also designed specifically for use in cancer patients to measure physical symptom distress, psychological distress, activity level and global QOL. The RSCL has been found to be both reliable (ICC = 0.78 - 0.87, α = 0.80 - 0.88) and valid (convergent validity, r = 0.24 - 0.39 with Nottingham Health Profile) for patients with cancer; however, responsiveness data is lacking. Because of these limitations and the fact that this tool measures symptoms rather than QOL specifically, the reviewers are unable to recommend the RSCL at this time. Finally, the BCIA was only validated on women who were ≥2 years from diagnosis of breast cancer. It lacks responsiveness data and, has not been used in clinical research. The reviewers were also unable to locate a hard copy of the tool. Therefore, the BCIA is not recommended for use at this time.
Assessment of HRQOL is exceedingly important in the management of breast cancer. The EORTC-B23, BREAST-Q, FACT-B, and FACT-B+4 have been developed for use in the breast cancer population and demonstrate good clinical utility and excellent psychometric properties. The EOTRC QLQ-C30, FACT-G, FLIC, and the QLI-CV have been developed for use in cancer patients with acceptable validity in BCS, good clinical utility and excellent psychometric properties. The PAIS/PAIS-SR, WHOQOL-100, and the SF Health Surveys are generic measures of QOL that are valid in the breast cancer population and demonstrate good clinical utility and excellent psychometric properties. All 11 of these measures are highly recommended for use in BCS. Several other measures were developed specifically for breast cancer patients. However, the reviewers were unable to recommend these at this time due to lack of acceptable psychometric properties, especially data related to responsiveness. Further research would enhance the quantity and quality of available and effective assessments of HRQOL in BCS.
There are several factors that should be considered when interpreting the Task Force recommendations. An outcome measure may have been excluded in this review due to a lack of published data; the authors are aware that new studies may have been published after August 2013. For measures that could not be recommended at this time, additional information may become available that might elevate the task force recommendation in the future. The literature search was limited to English-language journals. Therefore journals in other languages were not reviewed which may have limited the number of QOL measures that could have been reviewed. Researchers and clinicians are encouraged to review the Task Force recommendations as well as each specific outcome measure for more extensive information. While the findings from this review can serve as a guide, ultimately, it is up to the clinician and researcher to identify the best available evidence in addition to patient values and expectations in order to appropriately administer the correct QOL outcome measure.111
Thank you to Genevieve Colon, SPT, University of Michigan-Flint; Andrew Scheimann, SPT, University of North Florida; and Gary Childs, MS, Drexel University Health Sciences Libraries for assisting with this project.
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