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.

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.

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.

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.

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.

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.

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.

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.