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Some results from MedLine, searching for FACT, access provided by Community of Science in 1996

Citation:Stewart-Amidei C, Functional Assessment of Cancer Therapy Scale.,J Neurosci Nurs 27: 4, 219-20, Aug, 1995.

Citation:Weitzner MA, Meyers CA, Gelke CK, Byrne KS, Cella DF, Levin VA, TheFunctional Assessment of Cancer Therapy (FACT) scale. Development of abrain subscale and revalidation of the general version (FACT-G) in patientswith primary brain tumors., Cancer 75: 5, 1151-61, Mar 1, 1995.
Abstract
BACKGROUND. This report describes the development and validationof a brain subscale for the Functional Assessment of Cancer Therapy (FACT)scale, and the revalidation of the subscales of the general version (FACT-G),which measure physical, social, family, emotional, and functional well-beingand the quality of the relationship with the physician.

METHODS. 101 patients with primary brain tumors, after giving informedconsent, participated in the last two phases of a four-phase validationprocess: item generation, item reduction, validation, and reliability testing.In the validation phase, FACT-G subscale and total scores as well as thebrain subscale scores were correlated with other tests of mood, response,bias, and quality of life (QOL). Test-retest reliability testing was performedwith 46 patients who had primary brain tumors.

RESULTS. Validity and reliability coefficients were high for the FACT-Gand brain subscale, except for the comparison with a second QOL measure(FP-QLI) and the Karnofsky Performance Status (KPS). The lower scores werethe result of inherent differences in the two QOL instruments and the relativelyhigh performance status of the brain tumor patients, which restricted theKPS score range.

CONCLUSION. The FACT-G has good psychometric properties supporting itsbroad generalizability and the brain subscale tests substantially differentQOL issues than the core instrument. Use of this scale with the additionof the brain subscale provides a well rounded view of the various aspectsof QOL from the patient's perspective. With modifications and further psychometrictesting, the brain subscale may have broader applicability to subpopulationsof patients with other brain disorders.


Citation:D'Antonio LL, Zimmerman GJ, Cella DF, Long SA, Quality of life andfunctional status measures in patients with head and neck cancer.,Arch Otolaryngol Head Neck Surg 122: 5, 482-7, May, 1996.
Abstract
OBJECTIVE: To assess the relationship among three validatedhead and neck-specific measures of functional status and a general measureof quality of life in patients with head and neck cancer.

DESIGNS: Cross-sectional study using medical chart review, patient interview,and test administration. SETTING: Academic tertiary referral center. PARTICIPANTS:Fifty adults patients 3 months to 6 years after major surgery for headand neck cancer. MAIN OUTCOME MEASURE: Scores from a general measure ofquality of life (the Functional Assessment of Cancer Therapy), a subscalespecific to head and neck cancer, the University of Washington Qualityof Life Questionnaire, and the Performance Status Scale for Head and NeckCancer Patients.

RESULTS: The disease-specific measures of functional status correlatewell with one another. However, there were low correlations between theFunctional Assessment of Cancer Therapy and the disease-specific measures,indicating that general and disease-specific instruments contribute uniqueinformation about quality of life.

CONCLUSION: A general measure of quality of life augments informationobtained by disease-specific instruments by interpreting functional statusin the broader scope of the patient's life.


Citation:Moinpour CM, Measuring quality of life: an emerging science.,Semin Oncol 21: 5 Suppl 10, 48-60; discussion 60-3, Oct, 1994.
Abstract
Quality of life (QOL) variables are increasingly includedas end points in cancer therapy trials, supplementing such traditionalend points as survival time in evaluating the effects of cancer treatments.Consensus has been reached that a number of QOL components (symptom statusand physical, emotional, role, and social functioning) should be measured.Assessing multiple health-related QOL dimensions, as compared with a globalscore, provides a more detailed accounting of specific effects of cancertreatment on patient functioning. Southwest Oncology Group QOL assessmentpolicies emphasize patient reports and the need for systematic qualitycontrol procedures. The Southwest Oncology Group QOL questionnaire comprisesa battery of categorical scales with established psychometric properties.A set of generic core scales is always included in the battery, and treatment-and disease-specific scales are developed for each trial. Other frequentlyused QOL questionnaires, such as the European Organization for Researchand Treatment of Cancer QLQ-C30, the Cancer Rehabilitation Evaluation Systemquestionnaire, and the Functional Assessment of Cancer Therapy are alternativeinstruments in current use. Quality of life findings from lung cancer clinicaltrials indicate a prevalence of symptom distress, fatigue, and declinein functional status, although patients also experience symptom managementproblems without treatment. A summary of preliminary QOL findings for twovinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park,NC; Pierre Fabre Medicament, Paris, France) trials (randomized and single-arm)in patients with non-small cell lung cancer show that symptom status wasas good or better for patients receiving vinorelbine compared with thosereceiving 5-fluorouracil/leucovorin in the randomized study. Differencesin other QOL dimensions were not detected. Findings for the single-armtrial of oral vinorelbine were generally consistent with those of the randomizedtrial.

Citation:Buccheri GF, Ferrigno D, Tamburini M, Brunelli C, The patient'sperception of his own quality of life might have an adjunctive prognosticsignificance in lung cancer., Lung Cancer 12: 1-2, 45-58, Mar,1995.
Abstract
Only 5-10% of patients with lung cancer (LC) can be expectedto be cured by radical treatments. In the remaining subjects the potentialsurvival benefit of treatment must be weighed, taking into considerationthe possible deterioration of quality of life (QL). Indeed, studies dealingwith different aspects of QL are being increasingly reported in LC. Ina few of them, the interesting observation was made that the patient-ratedQL correlated well with the subsequent clinical outcome. In the presentstudy we analyse 11 items of the Therapy Impact Questionnaire (a new instrumentof QL), assessing both disease and therapy impact on physical condition,functional status, concomitant emotional and cognitive factors and socialinteractions. Questionnaires were completed by 128 consecutive LC patients,who had been seen, in the years 1990 through 1993, either for a newly diagnosedcancer (40 patients), or after a successful operation (15 patients), orduring active and/or symptomatic treatment (73 patients). At the time ofthe QL assessment, a minimal set of demographic and clinical variableswas recorded. Univariate tests of survival showed that stage of disease,difficulty at work or doing the housework, weight loss, performance status,difficulty relaxing, having been felt unsure, and tumor cell type wereall associated, in decreasing order of significance, with prognosis. QLvariables correlated well with each other, but poorly with clinical anddemographic variables (an expected exception was the good correlation existingbetween working capacity/physical autonomy and the corresponding observerevaluation of performance status). This lack of correlations explains howQL variables maintained their significance in multivariate survival analyses.In the best multivariate model, the self-estimated difficulty at work ordoing the housework followed the stage of disease, but preceded weightloss as a significant, independent, prognostic determinant. Further studiesevaluating several other additional prognostic indicators are needed tobetter clarify the relative prognostic importance of quality of life.

Citation:Hollen PJ, Gralla RJ, Kris MG, Cox C, Quality of life during clinicaltrials: conceptual model for the Lung Cancer Symptom Scale (LCSS).,Support Care Cancer 2: 4, 213-22, Jul, 1994.
Abstract
To appreciate the full benefits of treatment for lung cancer,especially in trials that fail to show improvements in survival, data recordingthe quality of life must be captured and refined to produce meaningfulinformation. A conceptual model for quality of life for lung cancer patientswas tested to obtain information about the dimensions of the quality-of-lifeconstruct for ongoing development and testing of a subjective measure forclinical trials. Using a longitudinal study design, the stability of predictivefactors of the physical and functional dimensions of quality of life wereexamined using regression analysis. A patient-rated quality-of-life measure,the Lung Cancer Symptom Scale (LCSS), was administered to 144 non-small-celllung cancer patients at baseline, day 29, and day 71 of a chemotherapytrial. The range of explained variance for all three components of thelung cancer model over three assessment points was as follows: symptomaticdistress 41%-53%, activity status 48%-52%, and overall quality of life35%-53%. The three dimensions fluctuated slightly during intervention,but were relatively stable factors across all three times of evaluation.The LCSS model explained nearly half of the variance for quality of lifeexperienced by lung cancer patients during therapy with a new chemotherapeuticagent. These findings provide support that the physical and functionaldimensions are important predictors of quality of life for individualswith lung cancer. Meaningful subjective quality-of-life data can be obtainedto evaluate an intervention by using a disease- and site-specific quality-of-lifemeasure for individuals with lung cancer, based on a reproducible conceptualmodel such as the LCSS, which is suitable for serial measurement for theprogressive disease of lung cancer.

Citation:Yellen SB, Cella DF, Someone to live for: social well-being, parenthoodstatus, and decision-making in oncology., J Clin Oncol 13: 5,1255-64, May, 1995.
Abstract
PURPOSE: Little is known about the influence of social factorson treatment preferences and desire for aggressive cancer therapy. Thepresent study assessed subjective and objective social indicators in patientpreferences for treatment.

METHODS: Cancer patients (N = 296) with diverse diagnoses and stagesread sets of hypothetical vignettes describing patients with early-stageand advanced disease. In the first set, patients made decisions about treatmentacceptance given varying levels of either increasing cure or extendingsurvival. In the second set, the point at which patients shifted preferencesfrom mild to severe treatment to improve likelihood of 1-year survival(switch point) was the dependent measure. We assessed the impact of quality-of-life(QL) domains measured by the Functional Assessment of Cancer Therapy-General(FACT-G), having children, marital status, and living arrangements on treatmentpreferences and switch points.

RESULTS: The Social Well-Being (SWB) subscale of the FACT-G predictedboth treatment acceptance (P = .007) and switch point (P = .043) in theadvanced-disease vignettes, with lower SWB associated with less aggressivepreferences. Children living at home was likewise associated with moreaggressive intent both in treatment preferences (P = .003, advanced-diseasevignette) and switch point (P < .001 and P = .001 for early- and advanced-diseasevignettes, respectively). Living with others predicted more aggressiveintent in the advanced-disease vignette (P = .03). Marital status did notpredict either treatment acceptance or switch point.

CONCLUSION: Positive social well-being, as well as having children livingat home, predicted patient willingness to accept aggressive treatment.Willingness to receive aggressive treatment may explain or mediate previouslyreported salutory effects of social support on cancer outcomes.


Citation:Price P, Jones T, Can positron emission tomography (PET) be usedto detect subclinical response to cancer therapy? The EC PET Oncology ConcertedAction and the EORTC PET Study Group., Eur J Cancer 31A: 12,1924-7, Nov, 1995.
Abstract
At the EORTC NCI New Drug Development Meeting in Amsterdamin 1994, a workshop, suggested by the EC PET (positron emission tomography)Oncology concerted action, was held to bring together many of those EuropeanPET centres investigating the use of [18F]FDG ([18F]2-fluoro-2 deoxyglucose)PET scanning as a measure of response to cancer therapy. Of the current31 PET centres in Europe invited to contribute, 15 centres already haddata and others expressed interest. Many of the groups were collaboratingwith local oncologists to measure tumour response to chemotherapy (12 groups)and radiotherapy (three groups) with this technique. Despite variationsof methodology, and difficulties in data interpretation, assessment oftumour [18F]FDG uptake was thought to be a reasonable method for the functionalimaging of tumours, assessing metabolic rate and providing a measure oftumour response. Broadly, pooling experience, it would appear that changesin [18F]FDG tumour uptake following one or two cycles of chemotherapy treatmentwas related to ultimate clinical responses. Patients showing most reductionin [18F]FDG uptake achieved the best clinical responses. Data were alsoavailable on the effect of chemotherapy on normal tissues and some dataon the effect of radiotherapy and tumour response. It was concluded thatchanges in [18F]FDG uptake as measured with PET may provide useful informationon clinical as well as subclinical response of tumours to anticancer therapy.This could be useful as a guide to early response to therapy as well asproviding functional assessment of residual masses of disease. More specificmarkers of cellular proliferation e.g. [11C]thymidine, or [11C]- aminoacids may provide even more accurate information. A strategy was outlinedwhereby PET scanning protocols could parallel EORTC early clinical trialsso that [18F]FDG response information could supplement phase I and II clinicalstudies. Following these developments, an EORTC study group was formedunder the auspices of the EORTC research branch, and the strategy for futuredevelopment in Europe outlined.

Citation:Price P, Jones T, Can positron emission tomography (PET) be usedto detect subclinical response to cancer therapy? The EC PET Oncology ConcertedAction and the EORTC PET Study Group., Eur J Cancer 31A: 12,1924-7, Nov, 1995.
Abstract
At the EORTC NCI New Drug Development Meeting in Amsterdamin 1994, a workshop, suggested by the EC PET (positron emission tomography)Oncology concerted action, was held to bring together many of those EuropeanPET centres investigating the use of [18F]FDG ([18F]2-fluoro-2 deoxyglucose)PET scanning as a measure of response to cancer therapy. Of the current31 PET centres in Europe invited to contribute, 15 centres already haddata and others expressed interest. Many of the groups were collaboratingwith local oncologists to measure tumour response to chemotherapy (12 groups)and radiotherapy (three groups) with this technique. Despite variationsof methodology, and difficulties in data interpretation, assessment oftumour [18F]FDG uptake was thought to be a reasonable method for the functionalimaging of tumours, assessing metabolic rate and providing a measure oftumour response. Broadly, pooling experience, it would appear that changesin [18F]FDG tumour uptake following one or two cycles of chemotherapy treatmentwas related to ultimate clinical responses. Patients showing most reductionin [18F]FDG uptake achieved the best clinical responses. Data were alsoavailable on the effect of chemotherapy on normal tissues and some dataon the effect of radiotherapy and tumour response. It was concluded thatchanges in [18F]FDG uptake as measured with PET may provide useful informationon clinical as well as subclinical response of tumours to anticancer therapy.This could be useful as a guide to early response to therapy as well asproviding functional assessment of residual masses of disease. More specificmarkers of cellular proliferation e.g. [11C]thymidine, or [11C]- aminoacids may provide even more accurate information. A strategy was outlinedwhereby PET scanning protocols could parallel EORTC early clinical trialsso that [18F]FDG response information could supplement phase I and II clinicalstudies. Following these developments, an EORTC study group was formedunder the auspices of the EORTC research branch, and the strategy for futuredevelopment in Europe outlined.

Citation:Cella DF, Dineen K, Arnason B, Reder A, Webster KA, karabatsos G, ChangC, Lloyd S, Steward J, Stefoski D, Validation of the functional assessmentof multiple sclerosis quality of life instrument., Neurology 47:1, 129-39, Jul, 1996.
Abstract
Based on scientific literature and interviews with cliniciansand patients, we developed a quality of life instrument for use with peoplewith MS called the Functional Assessment of Multiple Sclerosis (FAMS).The initial item pool consisted of 88 questions: 28 from the general versionof the Functional Assessment of Cancer Therapy quality of life instrument,plus 60 generated by patients, providers, and literature review. The validationsamples comprised a mail survey cohort (N = 377) and a clinical cohort(N = 56). Both cohorts provides evidence for internal consistency of thederived subscales, test-retest reliability, content validity, concurrentvalidity, and construct validity. Principal components and Rasch measurementmodel analyses were applied sequentially to survey sample data, reducingtest length to 44 questions, divided into six subscales: mobility, symptoms,emotional well-being (depression), general contentment, thinking/fatigue,and family/social well-being. Fifteen initially rejected questions wereadded back as miscellaneous (unscored) questions for their potential clinicaland empirical value. The mobility subscale was strongly predictive of theKurtzke Extended Disability Status Scale and the Scripps Neurologic RatingScales. The other five subscales were not, indicating they measure aspectsof patient quality of life not captured by the neurologic exam. The final59-item English language instrument (FAMS version 2) is available for inclusionin clinical trials and clinical practice.

Citation:Murray KJ, Nelson DF, Scott C, Fischbach AJ, Porter A, Farnan N, CurranWJ Jr, Quality-adjusted survival analysis of malignant glioma. Patientstreated with twice-daily radiation (RT) and carmustine: a report of RadiationTherapy Oncology Group (RTOG) 83-02., Int J Radiat Oncol Biol Phys 31: 3, 453-9, Feb 1, 1995.
Abstract
PURPOSE: To quantify the quality of life of malignant gliomapatients treated on a randomized Phase I/II trial of twice-daily radiationtherapy (RT) and carmustine, using a modified quality adjusted survival(QAS) model, and to compare the QAS among assigned treatment arms.

MATERIALS AND METHODS: The Radiation Therapy Oncology Group (RTOG) accrued 786 malignantglioma patients to a Phase I/II randomized dose escalation trial of twice-dailyRT with carmustine from 1983 to 1989. Patients were randomized to one offour arms of hyperfractionated RT in 1.2 Gy twice daily (BID) fractions(64.8 Gy, 72.0 Gy, 76.8 Gy, or 81.6 Gy) or to either of two acceleratedhyperfractionated RT arms in 1.6 Gy BID fractions (48.0 or 54.4 Gy). Althoughpreliminary toxicity and survival data have been published, little informationis available regarding the quality of these patients' lives during andfollowing such therapy. QAS is a refinement of the methodology for assessingsurvival quality among breast cancer patients receiving adjuvant chemotherapy.The QAS method allows for inclusion of both improvement and decline inneurologic functional status. Patients were scored by the presence or absenceof 15 neurologic signs and symptoms at on-study and at every follow-up.Within each category were gradations of severity, with the quality survivaltime (Q-TIME) adjusted according to any changes in these neurologic findings.The summation of all changes in signs and symptoms were weighted by 1/15thand incorporated into the QAS model as QAS = Q-TIME-TOX-RRX. TOX was thetime spent with treatment-related toxicities, and RRX was the time spentin recovery from subsequent therapy.

RESULTS: Of 747 evaluable patients, the average QAS time was 18.5 months.The average QAS for the hyperfractionated arms of 64.8 Gy, 72.0 Gy, 76.8Gy, and 81.6 Gy were 15.6, 20.8, 10.0, and 13.7 months, respectively. Forthe accelerated hyperfractionated RT arms of 48.0 and 54.4 Gy, the averageQAS times were 13.1 and 13.4 months. The QAS time of the 72.0 Gy arm wassignificantly longer than that of all other groups, except the 64.8 Gyarm. As expected, the QAS times were strongly discriminated by both ageand Karnofsky Performance Scores (KPS) (p < 0.001). Younger patientsand patients with high KPS benefited most from assignment to the 72.0 Gyarm; QAS time was not significantly longer in any treatment arm among patientsover age 50 or with KPS scores of 80 or less.

CONCLUSIONS: This quality-adjusted survival methodology can be successfullyapplied to malignant glioma patients and permits a quantitative assessmentof the influence of investigational therapies on patient quality of life.This analysis confirms the potential benefit of intermediate dose (72.0Gy) hyperfractionated RT for selected malignant glioma patients.


Citation:Harrison LB, Zelefsky MJ, Armstrong JG, Carper E, Gaynor JJ, SessionsRB, Performance status after treatment for squamous cell cancer of thebase of tongue--a comparison of primary radiation therapy versus primarysurgery., Int J Radiat Oncol Biol Phys 30: 4, 953-7, Nov 15,1994.
Abstract
PURPOSE: To compare the quality of life and functional outcomein patients with squamous cell cancer of the base of tongue treated withprimary radiation vs. primary surgery.

METHODS AND MATERIALS: At our institution, patients with base of tonguecancer are primarily treated either by radiation or surgery depending uponthe philosophy of their primary physician. Primary radiation consists of45-54 Gy external beam radiation followed by an 192Ir implant deliveringan additional 20-30 Gy over 2-3 days. A neck dissection is done at thesame time as the implant for those with involved nodes. Primary surgeryconsists of resection of the base of tongue lesion, neck dissection andpostoperative radiation therapy. Because both groups have similar localcontrol in our experience (80-90%), we used a subjective performance statusscale for head and neck cancer patients to assess the quality of life inthese patients (0-100, 0 = worst function, 100 = normal function). Thisscale measures ability to eat in public, understandability of speech, andnormalcy of diet. There were 30 radiation patients (21: T1-T2; nine: T3-T4)and ten surgery patients (five: T1-T2; five: T3-T4) available for long-termquality of life assessment.

RESULTS: Patients treated with radiation had consistently better performancestatus scores and quality of life according to our study. This was truefor those with early (T1-2) as well as more advanced (T3-4) disease. Foreating in public, T1-2 patients had scores of 85 vs. 75 (p = .31) and T3-4patients had scores of 82 vs. 35 (p < .0001) for radiation vs. surgery,respectively. For understandability of speech, T1-2 patients had scoresof 92 vs. 65 (p = .0021), and T3-4 patients had scores of 95 vs. 35 (p< .0001) for radiation vs. surgery, respectively. For normalcy of diet,T1-2 patients had scores of 74 vs. 50 (p = .047), and T3-4 patients hadscores of 78 vs. 32 (p = .0012) for radiation vs. surgery, respectively.In addition, we compared scores for early vs. advanced disease treatedby the same modality. For radiation, there was no difference in all threefunctional categories for T1-2 vs. T3-4 (p = .84), showing that qualityof life scores remain high for all stages. For surgery, functional statusdeteriorated significantly when comparing T1-2 vs. T3-4 (p = .0014), consistentwith the fact that larger tumors require more extensive operations.

CONCLUSION: Radiation therapy provides a better performance status thansurgery for base of tongue cancer. This is true for both early and advanceddisease. Because radiation also provides similar local control and survival,our data suggests that radiation may be the preferred strategy. Functionalscores remain high for all T stages treated with radiation, but deterioratewith more advanced T stages for patients treated with surgery. Similarstudies using objective criteria are needed to further compare these treatments.


Citation:Watkins-Bruner D, Scott C, Lawton C, DelRowe J, Rotman M, Buswell L,Beard C, Cella D, RTOG's first quality of life study--RTOG 90-20: aphase II trial of external beam radiation with etanidazole for locallyadvanced prostate cancer [see comments], Int J Radiat Oncol Biol Phys 33: 4, 901-6, Nov 1, 1995.
Abstract
PURPOSE: To assess institutional and patient compliance withquality of life (QL) instruments in RTOG clinical trials. To assess feasibilityof using the Functional Assessment Cancer Therapy (FACT), Sexual AdjustmentQuestionnaire (SAQ), and Changes in Urinary Function (CUF) QL instrumentsin a prostate clinical trial and to compare patient self-report of symptomsto medical professional ratings of the same symptoms using the RTOG acutetoxicity rating scales.

METHODS AND MATERIALS: Three self-assessment QL instruments, the FACT,the SAQ, and CUF, were to be administered to patients on a Phase II locallyadvanced prostate trial at specified time points. Specific instructionsfor both data managers and for patients on when, how, and why to fill outthe questionnaires were included.

RESULTS: Sixty-seven percent (24 out of 36) of patients accrued to RTOG90-20 completed both the initial FACT and SAQ. Eighty-five percent completedFACT at end of RT and 73% at 3 months. Eighty-one percent completed SAQat end of treatment, while 69% completed this form at 3 months. Compliancedrops off thereafter. Seventy-five percent of patients who had their symptomof dysuria rated by a medical professional as 0 on the RTOG toxicity ratingscale self-reported the same. Only 56% of patient self-reports on FACTregarding diarrhea were in agreement with the medical professional's RTOGrating of 0 toxicity. The measures were determined to be in moderate agreementwhen the patient evaluated a symptom as a 1 on the FACT and the medicalprofessional rated the same symptom as a 0 on the RTOG toxicity ratingscale. There was moderate agreement in 13% of patients with dysuria and31% of patients with diarrhea. Low agreement occurred when the patientevaluated a symptom as a 2 or 3 on the FACT and the medical professionalrated the same symptom as a 0 on the RTOG scale. Low agreement occurredin 13% of both patients reporting dysuria and diarrhea. Differences betweenhow medical professionals and patients were able to rate erectile functionmake direct comparisons difficult, but the trend towards significant discrepanciesis still noteworthy.

CONCLUSIONS: Quality of life assessments are necessary and attainablein RTOG clinical trials. Compliance rates for both institutional and patientparticipation were acceptable at initial and 3 month follow-up. Reasonsfor noncompliance were predominantly institution related and not patientrelated. Strategies to address both institution and patient compliancehave been developed and implemented within the RTOG. Serious disagreementbetween patient self-reports of symptoms on the FACT QL scale and medicalprofessional ratings on the RTOG acute toxicity rating scales of the samesymptoms was 13% at 3 months follow-up. This warrants continued use ofQL self-assessments in clinical trials.


Citation:Seidman AD, Portenoy R, Yao TJ, Lepore J, Mont EK, Kortmansky J, OnettoN, Ren L, Grechko J, Beltangady M, et al, Quality of life in phase IItrials: a study of methodology and predictive value in patients with advancedbreast cancer treated with paclitaxel plus granulocyte colony-stimulatingfactor., J Natl Cancer Inst 87: 17, 1316-22, Sep 6, 1995.
Abstract
BACKGROUND: Despite the clinical benefit that may be associatedwith reduction of tumor volume, chemotherapy may produce physical or psychologicaldistress that could compromise a patient's quality of life. Although palliationmay be as relevant as tumor response in patients with metastatic breastcancer, quality of life is not commonly evaluated in phase II clinicaltrials of new therapeutic agents. PURPOSE: We evaluated the utility ofquality-of-life assessment in two phase II clinical trials of patientsreceiving paclitaxel (Taxol) and recombinant human granulocyte colony-stimulatingfactor (rhG-CSF) as salvage therapy for metastatic breast cancer.

METHODS: A battery of instruments (i.e., Memorial Symptom AssessmentScale [MSAS], Functional Living Index-Cancer [FLIC], Rand Mental HealthInventory [MHI], Brief Pain Inventory [BPI], and Memorial Pain AssessmentCard [MPAC]) designed to capture information about social, psychological,and functional aspects of quality of life, as well as symptom prevalenceand distress, was completed prior to treatment; serial assessments wereobtained at regular intervals during the treatment period. Univariate andmultivariate analyses were performed evaluating base-line quality-of-lifeparameters and standard prognostic factors in relation to outcome measuresof survival, tumor response, and toxicity. For 30 consecutive patientswith extensive prior chemotherapy for metastatic disease, longitudinaldata were analyzed associating tumor response to changes in quality-of-lifescores throughout the course of treatment with paclitaxel.

RESULTS: Base-line scores of two validated quality-of-life instruments,the MSAS and the FLIC, independently predicted the overall survival (P< .01 for each). In this model, however, neither standard prognosticfactors nor quality of life instruments predicted the likelihood of tumorresponse or the probability of encountering grade 3 or grade 4 nonhematologictoxicity. With serial assessments of quality of life, the majority of patientswho achieved partial tumor response or stable disease reported improvedor unchanged quality-of-life scores, while those patients with progressivedisease experienced rapid deterioration in quality of life.

CONCLUSIONS: Base-line quality-of-life assessment may provide prognosticinformation distinct from that obtained through standard prognostic indicatorsalone. The combination of two factors--extent of disease and a base-linequality-of-life assessment--predicted survival more accurately than eitherused separately. Evaluation of quality-of-life outcomes in relation totumor response may illuminate previously unmeasured palliative effectsof chemotherapy, such as pain relief, as well as the burdens it imposes.IMPLICATIONS: Information obtained from quality-of-life assessment in conjunctionwith phase II testing of new chemotherapeutic agents for metastatic breastcancer can guide quality-of-life evaluation planned in large, randomizedfuture studies.


Citation:Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, SilbermanM, Yellen SB, Winicour P, Brannon J, et al, The Functional Assessmentof Cancer Therapy scale: development and validation of the general measure.,J Clin Oncol 11: 3, 570-9, Mar, 1993.
Abstract
PURPOSE: We developed and validated a brief, yet sensitive,33-item general cancer quality-of-life (QL) measure for evaluating patientsreceiving cancer treatment, called the Functional Assessment of CancerTherapy (FACT) scale.

METHODS AND RESULTS: The five-phase validation process involved 854 patients withcancer and 15 oncology specialists. The initial pool of 370 overlappingitems for breast, lung, and colorectal cancer was generated by open-endedinterview with patients experienced with the symptoms of cancer and oncologyprofessionals. Using preselected criteria, items were reduced to a 38-itemgeneral version. Factor and scaling analyses of these 38 items on 545 patientswith mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G,version 2). In addition to a total score, this version produces subscalescores for physical, functional, social, and emotional well-being, as wellas satisfaction with the treatment relationship. Coefficients of reliabilityand validity were uniformly high. The scale's ability to discriminate patientson the basis of stage of disease, performance status rating (PSR), andhospitalization status supports its sensitivity. It has also demonstratedsensitivity to change over time. Finally, the validity of measuring separateareas, or dimensions, of QL was supported by the differential responsivenessof subscales when applied to groups known to differ along the dimensionsof physical, functional, social, and emotional well-being.

CONCLUSION: The FACT-G meets or exceeds all requirements for use inoncology clinical trials, including ease of administration, brevity, reliability,validity, and responsiveness to clinical change. Selecting it for a clinicaltrial adds the capability to assess the relative weight of various aspectsof QL from the patient's perspective.


Citation:Groll S, Weidenhammer W, Schmidt A, [Considerations on the use ofthe construct "Quality of life" as a goal variable in clinicalresearch], Schweiz Rundsch Med Prax 80: 20, 560-4, May 14, 1991.
Abstract
In recent years the importance of the assessment of qualityof life increased, especially in palliative therapy. Commonly used conceptsof quality of life comprise of several dimensions, e.g. somatic disorders,functional status, well-being and social interaction. We developed an 18-itemquestionnaire, self-administered by the patients, and compared the resultsof 66 'healthy' subjects with two clinical samples: 126 patients with inoperablenon-small-cell lung cancer and 19 patients under dialysis. The resultsindicate the questionnaire as a sufficiently reliable and valid methodfor the assessment of 'quality of life'. On the other hand, there are severalproblems concerning an adequate interpretation when regarding our clinicaldata. For example, the cancer patients show a significantly more positiveself-assessment concerning well-being and activity, compared to 'healthy'subjects.

Citation:Sneeuw KC, Aaronson NK, Yarnold JR, Broderick M, Regan J, Ross G, GoddardA, Cosmetic and functional outcomes of breast conserving treatment forearly stage breast cancer. 2. Relationship with psychosocial functioning.,Radiother Oncol 25: 3, 160-6, Nov, 1992.
Abstract
The relationship between cosmetic and functional resultsof breast conserving therapy and psychosocial functioning was examinedin a sample of 76 patients with early stage breast cancer, who receivedtreatment between 1975 and 1985. The patients were interviewed at theirhomes regarding breast cosmesis, arm functioning and psychosocial health,and subsequently attended the hospital for independent assessment of cosmeticand functional outcomes by clinical observers. High levels of psychologicaldistress, disturbance of body image, and decreased sexual functioning werenoted in approximately one-quarter of the study sample. About half of thepatients expressed heightened concern with disease recurrence and theirfuture health. Psychosocial problems were only modestly associated withtreatment-related cosmetic and functional outcomes, as determined by clinicalratings and objective assessments. The patients' own ratings of breastcosmesis and arm functioning exhibited somewhat higher correlations withself-reported psychosocial functioning. In particular, a significant associationwas noted between the patients' ratings of overall cosmesis and arm edemaand their body image (r = 0.48 and r = 0.43, respectively). The associationbetween cosmetic and functional results and self-reported psychosocialhealth was strongest among those patients younger in age and treated longerago. These findings suggest that, in order to evaluate the impact of breastconserving therapy on the patients' quality of life, the patients' ownassessments of cosmetic and functional outcomes should be used as a primarysource of information.

Citation:Tamburini M, Rosso S, Gamba A, Mencaglia E, De Conno F, VentafriddaV, A therapy impact questionnaire for quality-of-life assessment inadvanced cancer research., Ann Oncol 3: 7, 565-70, Jul, 1992.
Abstract
The first part of the validation procedure used for a TherapyImpact Questionnaire (TIQ) on quality-of-life assessment in advanced cancerpatients is described. The TIQ is composed of 36 items which assess bothdisease and therapy impact according to four dimensions that operationallydefine quality of life: physical symptoms (24 items), functional status(3 items), concomitant emotional and cognitive factors (6 items) and socialinteraction (2 items). A global judgement expressed as "have you beenfeeling ill" further completes the TIQ. Patients answered each questionusing a 4-point verbal Likert scale: not at all, slight, a lot and verymuch. The TIQ was given to 1,000 consecutive patients who were no longerresponsive to cancer treatment and presented symptoms due to disease progression.The compliance rate was quite high (87%). Results of confirmatory factoranalysis were consistent with the operational dimensions identified duringquestionnaire construction. In particular, the dichotomized answers to3 functional status items could be used as a Guttman scale. In a sub-sampleof 50 patients, the reproducibility of functional status items was assessedusing a 7-item parallel form. The intraclass correlation coefficient obtainedindicated a reasonably high reproducibility. On the basis of the analysesconducted, the TIQ appears to be a reliable and concise instrument forstudies aimed to assess the effectiveness of therapies in advanced cancerpatients.

   
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