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This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.
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PMID:Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. 909 63

Anemia, frequently associated with cancer and cancer treatment, can use a variety of symptoms that diminish overall quality of life (QOL). Fatigue is the most commonly reported symptom among cancer patients and can significantly affect their daily lives. Using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, which measures general QOL, as a core questionnaire, 20 new questions related to the impact of fatigue and other anemia-related symptoms on patients with cancer were developed. Two new instruments were produced: the FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items (the Fatigue Subscale), and the FACT-Anemia (FACT-An), consisting of the FACT-F plus seven items addressing other concerns related to anemia, but unrelated to fatigue. FACT-F and FACT-An demonstrated good stability (r = .87 for both) and strong internal consistency (alpha = .95 and .96, respectively). Test-retest reliability coefficients for the Fatigue Subscale and nonfatigue items also showed good stability (r = .84 to .90), and the Fatigue Subscale showed strong internal consistency (alpha = .93 to .95). Convergent and discriminant validity testing revealed a significantly positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and an anticipated lack of relationship with social desirability. The FACT-An, FACT-F, and Fatigue Subscale were found to successfully discriminate patients based on hemoglobin (Hb) level and Eastern Cooperative Oncology Group (ECOG) performance status. When patients were divided into two groups by Hb levels, patients with Hb levels greater than 12 g/dL reported significantly less fatigue, fewer nonfatigue anemia symptoms, better physical well-being, better functional well-being, and higher general QOL. The FACT-An, the FACT-F, and the Fatigue Subscale are useful measures of QOL in cancer patients and add focus to the widespread clinical problems of anemia and fatigue.
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PMID:The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. 925 79

Anemia is a multi-symptom syndrome involving both physical and emotional problems that can be evaluated for their impact on quality of life. Fatigue is the cardinal symptom of anemia, reported by three of four cancer patients using the general version of the Functional Assessment of Cancer Therapy (FACT-G) questionnaire. A subscale of the FACT-G, consisting of the FACT-Fatigue (FACT-F) and the FACT-Anemia (FACT-An), has been developed to specifically address this problem. The FACT-F is comprised of the FACT-G plus 13 questions related to fatigue, while the FACT-An is comprised of the FACT-F plus an additional set of seven miscellaneous (non-fatigue) questions relevant to anemia in cancer patients. The FACT-An subscale was initially validated in a cohort of 50 cancer patients. Tests of internal consistency and stability confirmed the reliability of the fatigue component, as well as that of the FACT-G (27 items), the FACT-F (FACT-G plus 13 fatigue items), and the FACT-An (FACT-G plus 20 anemia subscale items) measurement systems. Quality of life scores on these FACT scales significantly decline as patient performance status worsens, and the scales correlate well with other questionnaires (Profile of Mood States and Piper Fatigue Scale) purported to measure the same thing. The scores on the FACT-An subscale also clearly differentiate between patients with low and high hemoglobin levels. Low hemoglobin levels are associated with greater fatigue, poorer overall quality of life, and decreased ability to work (beyond that related directly to fatigue). Interventions that reverse fatigue and other anemia-related symptoms should have a positive effect on quality of life.
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PMID:Factors influencing quality of life in cancer patients: anemia and fatigue. 967 30

Quality of life (QoL) was investigated in 56 BMT recipients. The objective was to compare QoL in terms of physical, emotional, and social functioning between patients within the first year after BMT (n = 15) and patients who were alive more than 1 year after BMT (n=41). The Functional Assessment of Cancer Therapy Scale (FACT-BMT) and the EORTC-Quality of Life Questionnaire (EORTC-QLQ C30) were used to evaluate QoL as perceived by the patients. Results show a significantly reduced general QoL in patients within the first year after BMT. Specific differences were identified on the dimensions of physical and emotional well-being and the symptom scales of appetite loss, fatigue, pain, dyspnea, and nausea and vomiting. QoL improves significantly with time after BMT. We suggest that there should be more integration of QoL expectancy into the pre-BMT information process. Patients should be informed about potential deficits in physical and emotional well-being within the first year after BMT. This could enhance insight and compliance in the critical period early after BMT.
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PMID:Time after bone marrow transplantation as an important variable for quality of life: results of a cross-sectional investigation using two different instruments for quality-of-life assessment. 976 Jan 49

It is of great importance to collect data of objective as well as subjective morbidity in patients cured for Hodgkin's disease. Such information may be used when new treatment strategies are discussed, in patients information and communication, to establish rehabilitation programs and to identify individuals who may benefit from rehabilitation. Measurement of health related quality of life (HRQOL) may give important information on how the cancer and/or the treatment has influenced the patients. There is no gold standard instrument for measurement of HRQOL in cancer. However, it is a consensus to use multidimensional patients rated measures with a standard format and scoring procedure. SF-36, EORTC QLQ-C30 and FACT are widely used in Europe and North America. Domain specific instruments includes a more comprehensive evaluation of a specific domain, for example anxiety or fatigue. Fatigue seems to be a prevalent symptom in Hodgkin's disease survivors and might affect patients' ability to perform normal activities and will often reduce their quality of life. Fatigue is defined as a subjective feeling of tiredness and might be measured by standardised and validated instruments such as the Fatigue Questionnaire (FQ) and the Multi-Dimensional Fatigue Inventory (MFI-20). Clinical significance might be defined as a meaningful difference based on consensus by the patient, the doctor and the society. In oncology there is no agreement of how long a meaningful difference in survival should be. For HRQOL a difference between 7 to 10 on a scale ranking from 0 to 100 has been regarded as clinical significant by some researchers. Another strategy to approach the issue of clinical significance is to use norms-estimates from the normal population- and/or reference estimates as guidelines. The long-term complication of the successful treatment of Hodgkin's disease reinforced the need for continued surveillance of treatment and related morbidities. Fatigue is a prevalent symptom and detailed diagnostic work-up is essential to identify patients with this problem. More knowledge about possible biological causes is required in order to understand fatigue and the impact on quality of life among Hodgkin's disease survivors.
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PMID:Hodgkin's disease: quality of life in future trials. 992 54

The purpose of this study was to compare the quality of life (QOL) of male and female allogeneic BMT recipients. One hundred and nine BMT patients participated in this cross-sectional survey and completed the following instruments: Functional Assessment of Cancer Treatment (FACT-BMT version 3), shortened version of Profile of Mood States (POMS), MOS Survey of Social Support, and A Brief Measure of Social Support (SSQ6). Independent of the time post-BMT, perceived physical well-being, age at BMT, and education, females reported worse emotional well-being and more fatigue than males. Females also indicated more tiredness and less quality sleep. Males were found to experience less satisfaction with social support regardless of marital status. On the other hand, married males were more satisfied with their sexual life, more interested in sexual relationships, and more sexually active compared to married females. However, no significant differences between males and females were found in terms of overall physical, functional, and social well-being assessed by the FACT-BMT. The present results indicated that important gender differences exist among allogeneic BMT recipients which need to be addressed when designing post-treatment intervention programs for BMT recipients.
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PMID:Gender-associated differences in the quality of life after allogeneic BMT. 1159 25

This study examined the criterion validity and sensitivity and specificity of a single item to rapidly screen patients in ambulatory oncology clinics for cancer-related fatigue. In an effort to expand the utility of the Zung Self-Rating Depression Scale (ZSDS) as a screen for other symptoms, the utility of the single fatigue item was examined. The fatigue item reads "I get tired for no reason" and is rated on a four-point scale ranging from "none or a little of the time" to "most or all of the time." Fifty-two subjects were administered the Zung, the Functional Assessment of Cancer Therapy-Anemia (FACT-An) scale, and the Fatigue Symptom Inventory (FSI). The Zung item was highly correlated with the ZSDS (r= 0.63, p < 0.0001) and the FACT-An (r = -0.70, p < 0.0001), as well as to the individual items of the FSI, ranging from 0.41 (p < 0.003) to 0.71 (p < 0.0001). All 10 subjects considered to be depressed based on the ZSDS were also considered to fatigued on the FACT-An. Setting the ZSDS item cutoff point at level 3--"A good part of the time"--yielded a sensitivity of 78.95% and a specificity of 87.88%. It is concluded that a single item can be a fast and accurate way of screening cancer patients for fatigue to trigger additional follow-up, thus expanding the utility of a depression screening tool for problems other than the purely psychiatric.
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PMID:I get tired for no reason: a single item screening for cancer-related fatigue. 1172 96

Anemia is a common cause of cancer-related fatigue. A systematic review of the literature was performed to establish guidelines on the use of epoetin alfa for the treatment of anemia. The evidence in support of these guidelines was selected, reviewed, and summarized by the members of the Canadian Cancer and Anemia Guidelines Development Group. The effects of epoetin alfa on quality of life (QOL) in patients with cancer were examined in 5 randomized, placebo-controlled trials and 2 large, open-label, nonrandomized, community-based studies. The effects of epoetin alfa on red blood cell transfusion requirements were examined in 19 randomized controlled trials (RCTs) with 21 comparisons. All trials compared epoetin alfa to a suitable control group, examined specified outcome measures that could be analyzed, and studied patients with cancer who were receiving chemotherapy. Trials involving patients with hematologic malignancies originating in the bone marrow were excluded. Outcome measures included 1) quality of life (QOL) (as measured by scales including the Linear Analogue Self-Assessment [LASA] and the Functional Assessment of Cancer Therapy [FACT] subscales), and 2) transfusion requirements (as measured by the proportion of patients requiring transfusion and amount of transfusion). The analysis confirmed that epoetin alfa produced statistically significant and clinically relevant improvements in QOL in patients with cancer. The overall relative risk ratio for transfusion among patients receiving epoetin alfa was calculated to be 0.60 (95% Cl, 0.53-0.69; P < 0.00001), representing a 40% reduction in the proportion of patients requiring transfusion. These results support recommendations for the use of epoetin alfa in patients with cancer-related anemia.
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PMID:Epoetin alfa in cancer patients: evidence-based guidelines. 1172 99

Exhaustion and tiredness are frequent symptoms in cancer patients. They are caused by the tumour itself and by application of chemotherapy, surgery, radiation or cytokine treatment. Exhaustion and tiredness are not a consequence of lacking sleep or exaggerated physical or mental labour, but are due to several other factors: Anemia, tumour cachexia, toxicity of chemo- and radiation treatment probably are the most decisive factors for the development of exhaustion and tiredness. As both were taken as inevitable side-effects of cancer and cancer treatment in the past, only little attention has been paid to exhaustion and tiredness and limited research has been done. Among several validated questionnaires measuring quality of life in tumour patients the FACT-An (Functional Assessment of Cancer Treatment--Anemia) and EORTC QLQ-C30 questionnaire are the most well-known for identifying exhaustion and tiredness. Nevertheless, until today there is no mere exhaustion scale exclusively dealing with the problem of exhaustion and tiredness. According to the 10th revision of the International Classification of Diseases (ICD) exhaustion and tiredness are subsumed under the diagnosis of tumour fatigue. In contrast to tumour fatigue, which comprises physical, mental and emotional dimensions, exhaustion and tiredness primarily refer to physical symptoms: Lacking resilience for activities of daily life, day sleepiness and nocturnal insomnia as well as restricted power of concentration are the mainstays of exhaustion and tiredness. However, regarding lacking interests, diminished energy and reduced mental capacity, exhaustion and fatigue partly overlap. From a therapeutic point of view behavioural interventions and drug therapy have successfully been tried. Beside physical exercise and psychostimulants application of Erythropoietin represents an innovative treatment of exhaustion and tiredness.
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PMID:[Exhaustion and fatigue--a neglected problem in hematologic oncology]. 1178 24

Twenty-one patients with recurrent or metastatic breast cancer were treated with paclitaxel (Taxol) as a 1-hour infusion on day 1 only of a 14-day cycle. This treatment was followed by 5-fluorouracil (5-FU) via a portable home pump, through a central venous catheter at 350 mg/m2 per day over 24 hours for a total of 96 hours, on days 1 to 5 and again on days 8 to 12. Based on reported phase I trials in other organ system cancers, the first 5 patients were treated with paclitaxel at 150 mg/m2 every 2 weeks, but this was associated with excessive toxicity. Subsequent patients received paclitaxel at 135 mg/m2. The FACT-B scale was used to assess quality of life for patients on entry of the study and after three cycles. Treatment was well tolerated, with no grade III or IV hematologic toxicities. Grade III nonhematologic toxicities comprised one patient with fatigue, one with mucositis, and one with diarrhea. Grade IV nonhematologic toxicities included 1 hypersensitivity reaction to paclitaxel. Four of the 16 patients (25%) had pump-related problems resulting in disrupted 5-FU dosing in the home setting. The patients had the following responses to the treatment: complete response 0 (0%), partial response 6 (37.5%), stable disease 4 (25%), progression 4 (25%), unassessable 2 (12.5%)-1 anaphylaxis and 1 thrombocytopenia; overall response rate 6 of 16 (0.37; 95% CI, of 0.57). The median duration of survival was 14 months, 95% CI (5.6-18.24). The FACT-B was assessed in 14 patients at baseline and in 8 patients after 3 cycles. Quality of Life improved in 6 patients, no patients remained stable, and worsened in 2 patients. Biweekly paclitaxel with weekly 4-day continuous infusion 5-FU was associated with minimal toxicity but did not meet the target response rate of 60%. This response rate does not justify use of a complex home infusion of 5-FU.
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PMID:Phase II study of low-dose infusional 5-fluorouracil and paclitaxel (Taxol) given every 2 weeks in metastatic breast cancer. 1194 2


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