The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

Daily physical activity assessment with accelerometers: new insights and validation studies.

The field of application of accelerometry is diverse and ever expanding. Because by definition all physical activities lead to energy expenditure, the doubly labelled water (DLW) method as gold standard to assess total energy expenditure over longer periods of time is the method of choice to validate accelerometers in their ability to assess daily physical activities. The aim of this paper was to provide a systematic overview of all recent (2007-2011) accelerometer validation studies using DLW as the reference. The PubMed Central database was searched using the following keywords: doubly or double labelled or labeled water in combination with accelerometer, accelerometry, motion sensor, or activity monitor. Limits were set to include articles from 2007 to 2011, as earlier publications were covered in a previous review. In total, 38 articles were identified, of which 25 were selected to contain sufficient new data. Eighteen different accelerometers were validated. There was a large variability in accelerometer output and their validity to assess daily physical activity. Activity type recognition has great potential to improve the assessment of physical activity-related health outcomes. So far, there is little evidence that adding other physiological measures such as heart rate significantly improves the estimation of energy expenditure.

Advances in physical activity monitoring and lifestyle interventions in obesity: a review.

Obesity represents a strong risk factor for developing chronic diseases. Strategies for disease prevention often promote lifestyle changes encouraging participation in physical activity. However, determining what amount of physical activity is necessary for achieving specific health benefits has been hampered by the lack of accurate instruments for monitoring physical activity and the related physiological outcomes. This review aims at presenting recent advances in activity-monitoring technology and their application to support interventions for health promotion. Activity monitors have evolved from step counters and measuring devices of physical activity duration and intensity to more advanced systems providing quantitative and qualitative information on the individuals' activity behavior. Correspondingly, methods to predict activity-related energy expenditure using bodily acceleration and subjects characteristics have advanced from linear regression to innovative algorithms capable of determining physical activity types and the related metabolic costs. These novel techniques can monitor modes of sedentary behavior as well as the engagement in specific activity types that helps to evaluate the effectiveness of lifestyle interventions. In conclusion, advances in activity monitoring have the potential to support the design of response-dependent physical activity recommendations that are needed to generate effective and personalized lifestyle interventions for health promotion.

Assessment of human herpesvirus-6 infection in mesenchymal stromal cells ex vivo expanded for clinical use.

Infection or reactivation of human herpesvirus (HHV)-6 represents a potentially serious complication (often involving the central nervous system) in patients receiving either solid organ or hematopoietic stem cell transplantation. The objective of this study was to assess the risk of HHV-6 infection/reactivation in mesenchymal stromal cells (MSCs). MSCs are multipotent cells displaying immunomodulatory properties that have been already successfully used in the clinical setting to enhance hematopoietic stem cell engraftment and to treat steroid-refractory acute graft-versus-host disease. We analyzed 20 samples of ex vivo expanded MSCs, at different passages of culture, isolated both from bone marrow and from umbilical cord blood. Through Western blotting and immunocytochemistry techniques, we investigated the presence of the HHV-6 receptor (CD46) on cell surface, whereas the presence of HHV-6 DNA was evaluated by nested polymerase chain reaction assay. All of the MSC samples tested were positive for the virus receptor (CD46), suggesting their potential susceptibility to HHV-6. However, none of the MSC samples derived from cultures, performed in the perspective of clinical use, was found to harbor HHV-6. This preliminary observation on a consistent number of MSC samples, some of them tested at late in vitro passages, indicates a good safety profile of the product in terms of HHV-6 contamination. Nevertheless, it remains important to set up in vitro experimental models to study MSCs' susceptibility to HHV-6 (and HHV-7) infection, to verify their capacity to integrate the virus into cellular DNA, and to investigate which experimental conditions are able to induce virus reactivation.

Improving assessment of daily energy expenditure by identifying types of physical activity with a single accelerometer.

Accelerometers are often used to quantify the acceleration of the body in arbitrary units (counts) to measure physical activity (PA) and to estimate energy expenditure. The present study investigated whether the identification of types of PA with one accelerometer could improve the estimation of energy expenditure compared with activity counts. Total energy expenditure (TEE) of 15 subjects was measured with the use of double-labeled water. The physical activity level (PAL) was derived by dividing TEE by sleeping metabolic rate. Simultaneously, PA was measured with one accelerometer. Accelerometer output was processed to calculate activity counts per day (AC(D)) and to determine the daily duration of six types of common activities identified with a classification tree model. A daily metabolic value (MET(D)) was calculated as mean of the MET compendium value of each activity type weighed by the daily duration. TEE was predicted by AC(D) and body weight and by AC(D) and fat-free mass, with a standard error of estimate (SEE) of 1.47 MJ/day, and 1.2 MJ/day, respectively. The replacement in these models of AC(D) with MET(D) increased the explained variation in TEE by 9%, decreasing SEE by 0.14 MJ/day and 0.18 MJ/day, respectively. The correlation between PAL and MET(D) (R(2) = 51%) was higher than that between PAL and AC(D) (R(2) = 46%). We conclude that identification of activity types combined with MET intensity values improves the assessment of energy expenditure compared with activity counts. Future studies could develop models to objectively assess activity type and intensity to further increase accuracy of the energy expenditure estimation.

Improving chronic illness care: translating evidence into action.

The growing number of persons suffering from major chronic illnesses face many obstacles in coping with their condition, not least of which is medical care that often does not meet their needs for effective clinical management, psychological support, and information. The primary reason for this may be the mismatch between their needs and care delivery systems largely designed for acute illness. Evidence of effective system changes that improve chronic care is mounting. We have tried to summarize this evidence in the Chronic Care Model (CCM) to guide quality improvement. In this paper we describe the CCM, its use in intensive quality improvement activities with more than 100 health care organizations, and insights gained in the process.

Quality-of-life assessment in acute, chronic, and cancer pain: a pharmacist's guide.

OBJECTIVE: To describe instrumentation, or measures, available for use in assessing the impact of pain on the quality of life (QOL) of patients, and methods to evaluate the appropriateness of these QOL measures. DATA SOURCES: MEDLINE, PSYCHLit, and CANCERLit were searched from 1980 through 1997 to identify QOL instruments that included a pain subscale or pain-related items. DATA SYNTHESIS: Given the high prevalence of chronic diseases or conditions that include pain as a primary or secondary symptom, pharmacists should understand how pain affects the QOL of patients. Over the past two decades, emphasis has increased on developing instruments that assess health-related QOL concerns, including pain. Scores of measures--including utility measures--are available to measure general QOL in patients with conditions involving pain. Condition-specific instruments have also been developed to measure the impact of specific conditions, such as arthritis, on QOL. Guidelines are presented for evaluating QOL instrumentation, and existing measures used to evaluate the QOL of patients with acute and chronic pain are described. Pharmacists can use these guidelines to evaluate the usefulness of existing instruments for assessing the QOL of patients with pain. CONCLUSION: Using QOL measures in everyday practice may assist pharmacists in gaining insight into the effects of pain on their patients' QOL. This information may be useful in developing treatment programs that minimize pain and its associated side effects while maximizing patients' well-being.

Validation of the United States' version of the World Health Organization Quality of Life (WHOQOL) instrument.

In 1991, the World Health Organization initiated a project to simultaneously develop a quality of life (QOL) instrument in 15 countries: The World Health Organization Quality of Life (WHOQOL) instrument. This was intended as a generic QOL tool for use with patients across varying disease types, severities of illness, and cultural subgroups. The objective of the current study was to evaluate the WHOQOL-100 in the U.S., one of the original 15 participating countries. The WHOQOL is a 100-item self-report instrument consisting of 24 subscales within six domains: Physical, Psychological, Independence, Social, Environment, and Spiritual. Four additional items pertain to overall QOL/health. We tested the WHOQOL-100 (U.S. version) in a sample of 443 adults (n = 251 chronically ill, n = 128 healthy, and n = 64 childbearing) in the U.S. to test its reliability (internal consistency, test-retest), construct validity (convergent, discriminant), responsiveness, and factor structure. The WHOQOL-100 (U.S. version) has acceptable internal consistency (alpha range: 0.82-0.95 across domains) and reproducibility (ICC range: 0.83-0.96 at 2-week retest interval). It is responsive to change in clinical conditions, as evidenced by predicted score change (effect size) in women after childbirth. Construct validity was demonstrated by (1) its correlation with the Short Form-36 and Subjective Quality of Life Profile, and (2) its ability to discriminate between the diverse samples in this study. The conceptual structure was confirmed exactly with the exception of four facets that did not correlate most highly with the domains to which they were originally assigned, but these differences were minor. The WHOQOL measurement system is suitable for evaluating the QOL of adults in the U.S. The psychometric properties will be continually evaluated as more data become available in the U.S.

Cancer pain management: barriers, trends, and the role of pharmacists.

OBJECTIVES: To describe barriers to optimal cancer pain management, activities that have been implemented in recent years to partially overcome these barriers, and the importance of the pharmacist's role in the cancer pain management process. SUMMARY: Cancer pain management remains a formidable challenge. Barriers in the United States include inadequate provider training; patients' reluctance to report pain; and deficiencies within the health care infrastructure, such as restrictive regulation of controlled substances and inadequate insurance coverage. Despite these barriers, recent efforts have raised awareness of the gap between suboptimal and optimal cancer pain management. These include: the development of guidelines (and the conduct of scientific studies) to educate providers about pain management or gaps in the cancer pain management process; regulation that has lessened provider restrictions in prescribing analgesics; the emergence of patient and provider advocacy groups; and the development of pain assessment instruments. Because of their clinical and pharmacologic expertise, pharmacists are crucial to the shaping and success of cancer pain management strategies in the United States today. CONCLUSION: Despite its high prevalence and the increasing awareness of the effects of pain on quality of life, cancer pain management remains secondary to treatment of the disease itself. Refining the cancer pain management process in the United States will depend on continued education and emphasis on pain assessment and a proactive approach to pain management, provider groups' effective collaboration with each other and with patients, and overcoming legal, regulatory, and cost barriers.

Spanish language translation and initial validation of the functional assessment of cancer therapy quality-of-life instrument.

OBJECTIVES: There is a need in the United States for culture-equivalent assessment of health-related quality of life, particularly among people who speak different languages and among those with low literacy skills. This report summarizes the adaptation of the Functional Assessment of Cancer Therapy (FACT) Scales for use with Spanish-speaking cancer patients, including those with low literacy. METHODS: The Spanish language version of the general Functional Assessment of Cancer Therapy scale plus five disease-specific subscales (breast, lung, colorectal, head and neck, HIV infection) were translated, reviewed, and revised, then evaluated in interviews with Spanish-speaking patients from the mainland United States and Puerto Rico. An iterative forward-backward-forward sequence of item translation, expert bilingual/bicultural advisor review, pretesting interviews with 92 patients, and further expert advisory input were used to establish semantic, content, and partial technical equivalence. RESULTS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales were translated successfully into wording that was easily understood and answered, leading to psychometric and scoring data similar to that of the English version. All but one of the 28 Functional Assessment of Cancer Therapy-General items and all of the disease-specific items were seen as culturally relevant. The result is a document that underwent iterative forward-backward translation and evaluation and was pretested successfully with native Spanish-speaking oncology patients living in the Central United States and Puerto Rico. CONCLUSIONS: The Functional Assessment of Cancer Therapy-General and five disease-specific subscales have been translated successfully into Spanish using a thorough translation and initial validation methodology. The methods and data provide a model for preparing a health status questionnaire for cross-cultural validation. The questionnaire is available for use in clinical trials and clinical practice.

Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.

PURPOSE: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS: Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION: The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.

Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale.

We developed a 12-item bone marrow transplant subscale (BMTS) for the general Functional Assessment of Cancer Therapy (FACT) measure. The subscale combined with the FACT, (FACT-BMT) is a 47-item, valid and reliable measure of five dimensions of quality of life in bone marrow transplant patients. The three-step validation process involved the generation and selection of BMT-specific items and the testing of the overall measure. Items were selected from a list produced by seven oncology experts and 15 patients and were designed to assess content not represented in the general FACT items. A total of 182 patients completed the FACT-BMT at baseline, prior to BMT. An analysis measuring sensitivity to change was performed with 74 patients after transplantation and 60 patients over the three time-points of baseline, hospital discharge and 100 days. The FACT-BMT and all subscales were correlated, sensitivity to change was measured, and the internal consistency for each scale was calculated. Coefficients of reliability and validity ranged from 0.86 to 0.89 for the entire FACT-BMT and 0.54 to 0.63 for the BMTS. The BMTS was able to discriminate patients on the basis of performance status rating and also demonstrated sensitivity to change over time. The FACT-BMT has good psychometric properties for use in assessing quality of life in bone marrow transplant patients. The addition of the bone marrow transplant subscale to the general FACT measure makes it an excellent choice for use in BMT clinical trials.

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system.

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.

The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.

Quality of life in people with Hodgkin's disease.

The diagnosis and treatment of Hodgkin's disease are not without cost in terms of both short- and long-term sequelae that have an impact on quality of life. This paper reviews quality of life in Hodgkin's disease both during and after treatment, with a focus on medical, psychosocial, and psychological functioning. In general, patients with Hodgkin's disease emerge from successful treatment significantly affected. Often, the impact of the disease and its treatment has both positive and negative aspects. Positive effects include increased appreciation for life, enhanced self-esteem and sense of personal direction, and closer family ties. Negative effects include risk of second malignancy, infertility, difficulty with intimacy and sexuality, employment discrimination, insurance discrimination, increased general distress, and fear of recurrence. The many and diverse needs of Hodgkin's disease survivors merit increased attention from the health-care delivery system.

The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.