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PSYCHO-ONCOLOGY Psycho -Oncology 8: 355–363 (1999) DEVELOPMENT OF QUALITY OF LIFE QUESTIONNAIRE IN JAPAN: QUALITY OF LIFE ASSESSMENT OF CANCER PATIENTS RECEIVING CHEMOTHERAPY 1 MINORU KURIHARA a, *, HIROYUKI SHIMIZU b , KOJI TSUBOI c , KUNIHIKO KOBAYASHI d , MINORU MURAKAMI e , KENJI EGUCHI f,2 and KOJIRO SHIMOZUMA g a Department of Internal Medicine (Gastroenterology), Toyosu Hospital, Showa Uni6ersity, Tokyo, Japan b Department of Public Health, Gifu Uni6ersity, School of Medicine, Gifu, Japan c Department of Psychosomatic Medicine, Toho Uni6ersity, Tokyo, Japan d Department of 4th Internal Medicine, Nippon Medical College, Tokyo, Japan e Department of Hematology and Chemotherapy, Aichi Cancer Center Hospital, Nagoya, Japan f Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan g Department of Surgery, Breast and Thyroid Di6ision, Kawasaki Medical School, Kurashiki, Japan SUMMARY The Japanese Quality of Life Research Group has developed a general questionnaire suitable for assessing the Quality of Life (QOL) in patients undergoing chemotherapy. The questionnaire covers four major categories: (1) daily activities, (2) physical condition, (3) social activities, and (4) mental and psychological status. The State – Trait Anxiety Inventory (STAI), Self-Rating Depression Scale (SDS), and Performance Status (PS) were used as external measures of quality of life and for the validation of our tool. On the basis of two basic surveys and two studies we selected 22 questions from a larger set of items. Validity and reliability were verified for the final 22-question form. This questionnaire, named the QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs (QOL-ACD), can be used to detect changes in QOL over time. Its use as an additional outcome measure in Phase III chemotherapy trials should be encouraged. Copyright © 1999 John Wiley & Sons, Ltd. INTRODUCTION The quality of life (QOL) of cancer patients is not usually assessed in a scientific manner, as it is generally thought to be related to personal or subjective attributes which are difficult to quan- tify. However, we believe that QOL should be considered just as important as the cancer end- points response rate, disease-free survival, and overall survival. These endpoints in cancer treat- ment have generally been regarded as the sole determinants of the efficacy of cancer treatment, in some part due to the fact they can be assessed with relative ease. Since the Karnofsky Performance Status (KPS) score was first developed in 1948 (Karnofsky and Burchenal, 1949), various attempts have been made in Western countries to establish QOL mea- sures to assess the most important factors con- tributing to overall QOL, such as physical, psychological, and social aspects. Clinicians in Japan, however, have generally been indifferent to QOL assessment measures, utilizing only the KPS and Eastern Cooperative Oncology Group (ECOG) – Performance Status (PS) score, which assesses the physical aspect of QOL alone. How- ever, some concerned Japanese researchers have recently begun to evaluate the QOL of cancer patients using Japanese translations of the mea- sures developed in Western countries, such as the * Correspondence to: Department of Internal Medicine (Gas- troenterology), Toyosu Hospital, Showa University, 4-1-18, Toyosu, Koto-ku, Tokyo 135-8577, Japan. Tel.: +81 3 35341151; fax: +81 3 35319566. 1 Presented at the 2nd International Congress of Psycho-oncol- ogy in 1995. 2 Current address: Department of Internal Medicine, National Shikoku Cancer Center Hospital, Japan. CCC 1057–9249/99/040355 – 09$17.50 Copyright © 1999 John Wiley & Sons, Ltd. Recei6ed 19 March 1996 Accepted 10 March 1999

Development of Quality of Life Questionnaire in Japan: quality of life assessment of cancer patients receiving chemotherapy

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Page 1: Development of Quality of Life Questionnaire in Japan: quality of life assessment of cancer patients receiving chemotherapy

PSYCHO-ONCOLOGY

Psycho-Oncology 8: 355–363 (1999)

DEVELOPMENT OF QUALITY OF LIFEQUESTIONNAIRE IN JAPAN: QUALITY OF LIFE

ASSESSMENT OF CANCER PATIENTSRECEIVING CHEMOTHERAPY1

MINORU KURIHARAa,*, HIROYUKI SHIMIZUb, KOJI TSUBOIc, KUNIHIKO KOBAYASHId,MINORU MURAKAMIe, KENJI EGUCHIf,2 and KOJIRO SHIMOZUMAg

a Department of Internal Medicine (Gastroenterology), Toyosu Hospital, Showa Uni6ersity, Tokyo, Japanb Department of Public Health, Gifu Uni6ersity, School of Medicine, Gifu, Japan

c Department of Psychosomatic Medicine, Toho Uni6ersity, Tokyo, Japand Department of 4th Internal Medicine, Nippon Medical College, Tokyo, Japan

e Department of Hematology and Chemotherapy, Aichi Cancer Center Hospital, Nagoya, Japanf Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan

g Department of Surgery, Breast and Thyroid Di6ision, Kawasaki Medical School, Kurashiki, Japan

SUMMARY

The Japanese Quality of Life Research Group has developed a general questionnaire suitable for assessing theQuality of Life (QOL) in patients undergoing chemotherapy. The questionnaire covers four major categories: (1)daily activities, (2) physical condition, (3) social activities, and (4) mental and psychological status. TheState–Trait Anxiety Inventory (STAI), Self-Rating Depression Scale (SDS), and Performance Status (PS) wereused as external measures of quality of life and for the validation of our tool. On the basis of two basic surveysand two studies we selected 22 questions from a larger set of items. Validity and reliability were verified for thefinal 22-question form. This questionnaire, named the QOL Questionnaire for Cancer Patients Treated withAnticancer Drugs (QOL-ACD), can be used to detect changes in QOL over time. Its use as an additional outcomemeasure in Phase III chemotherapy trials should be encouraged. Copyright © 1999 John Wiley & Sons, Ltd.

INTRODUCTION

The quality of life (QOL) of cancer patients is notusually assessed in a scientific manner, as it isgenerally thought to be related to personal orsubjective attributes which are difficult to quan-tify. However, we believe that QOL should beconsidered just as important as the cancer end-points response rate, disease-free survival, andoverall survival. These endpoints in cancer treat-

ment have generally been regarded as the soledeterminants of the efficacy of cancer treatment,in some part due to the fact they can be assessedwith relative ease.

Since the Karnofsky Performance Status (KPS)score was first developed in 1948 (Karnofsky andBurchenal, 1949), various attempts have beenmade in Western countries to establish QOL mea-sures to assess the most important factors con-tributing to overall QOL, such as physical,psychological, and social aspects. Clinicians inJapan, however, have generally been indifferent toQOL assessment measures, utilizing only the KPSand Eastern Cooperative Oncology Group(ECOG)–Performance Status (PS) score, whichassesses the physical aspect of QOL alone. How-ever, some concerned Japanese researchers haverecently begun to evaluate the QOL of cancerpatients using Japanese translations of the mea-sures developed in Western countries, such as the

* Correspondence to: Department of Internal Medicine (Gas-troenterology), Toyosu Hospital, Showa University, 4-1-18,Toyosu, Koto-ku, Tokyo 135-8577, Japan. Tel.: +81 335341151; fax: +81 3 35319566.1 Presented at the 2nd International Congress of Psycho-oncol-ogy in 1995.2 Current address: Department of Internal Medicine, NationalShikoku Cancer Center Hospital, Japan.

CCC 1057–9249/99/040355–09$17.50Copyright © 1999 John Wiley & Sons, Ltd.

Recei6ed 19 March 1996Accepted 10 March 1999

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M. KURIHARA ET AL.356

Functional Living Index for Cancer (FLIC) andthe European Organization for Research andTreatment of Cancer (EORTC)-QOL question-naires. In 1993, Kurihara et al. developed the firstQOL assessment measure for Japanese cancer pa-tients, namely ‘The QOL Questionnaire for Can-cer Patients Treated with Anticancer Drugs’(QOL-ACD), the validity and reliability ofwhich were verified during its development.The effort to construct the questionnaire was ledby over 30 medical oncologists, surgeons, nurses,and psychologists nationwide. The studies re-ported here to evaluate the questionnaire haveinvolved numerous additional providers, as well ashundreds of patients. This paper provides detailsof the formulation and validation of the QOL-ACD.

METHODS

O6er6iew

The aim of this research was to develop a set ofquestions that accurately assess cancer-relatedquality of life in chemotherapy patients. To thisend, two research methods were used: (1) surveysto evaluate content validity of an initial pool ofitems and identify additional items, and (2) pilotstudies to assess the psychometric performance ofthe items selected (Table 1).

Sur6eys 1 and 2: item collection

In both surveys we sought to select question-naire items that were meaningful to both patientsand providers.

The members of the Japanese Quality of LifeResearch Group suggested there might be an orig-inal view of QOL in Japan. The 62 items in Survey1 were devised by 30 investigators (20 doctors,eight nurses, one dietitian and one psychologist)independently of the FLIC and EORTC-QLQ-C30. In Survey 2, these items were combined with27 items derived from the FLIC (8 items) (Schip-per and Levitt, 1985) and EORTC-QLQ-C33questionnaires (19 items) (Aalonson et al., 1987,1991). The items were translated into Japanese bytwo linguists. The resulting 89 items were evalu-ated by 68 investigators (27 doctors, 33 nurses, sixdietitians and two psychologists), and 21 cancerpatients. Thirteen of the 21 patients had advanceddisease (inoperable). Of the 89 items, 48 wereselected by a majority (\50%) of the 13 patientswith advanced disease who felt these questionswere important to measure their QOL. Two morequestions were added to the 48 items as a result ofendorsement by a majority (\75%) of the in-volved medical professionals. We also included a‘face scale’ question, comprised of five differentfacial expressions reflecting the patients overallcondition. They ranged from ‘worst’ to ‘best’ andwere selected from the 20 faces by Lorish andMaisia (1986). As a result of this process, a totalof 51 questions were selected for the pilot study.

Table 1. Overview of methods

Number ofParticipants (n)ObjectiveSubstudyitems

Item collectionSurvey 1 Content validation Investigators (30) 62Survey 2 89Content validation Investigators (68)

Cancer patients (21)

Item selectionStudy 1 Factor analysis Patients (121) 51

Concurrent validation

Patients (531)Clinical validation 36Study 2Benign (319)Cancer (212)

22Study 3 Construct validation Cancer patients (212)Concurrent validation

22Cancer patients (156)Reliability of scoring

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Study 1: item selection from the 51-item question-naire

The 121 subjects were Japanese patients withmalignancies (lung, stomach, colorectal, breast,and others) who were outpatients or admitted tothe one of 11 institutions belonging to the JapaneseQuality of Life Research Group from August 1990to October 1990. After informed consent had beenobtained to collect their QOL measures, the 51-item questionnaire, the State–Trait Anxiety Inven-tory (STAI) (Spielberger, 1975; Nakazato andShimozuma, 1989), and the Self-Rating DepressionScale (SDS) (Zung, 1965) were administered. Atthe same time, their doctors recorded the ECOGperformance status score (PS) for the patients.Most of the items were answered according to a5-point scale with ‘5’ indicating the ‘best’ and ‘1’indicating the ‘worst’ condition. For the 15 ques-tions inviting a simple dichotomous response, 5points were assigned to ‘good’ and 1 point to ‘bad’.The total score of the questionnaire is the simplesum of the points of all items. For item reduction,the response rate of each item was first checked todelete non-responsive items. As a second step,factor analysis with varimax rotation was per-formed to identify items that have high correla-tions with one another. In a third step, correlationsbetween each item and the scores of STAI, SDS,and PS were calculated.

Study 2: item selection from the 36-itemquestionnaire

After the reduction of the items from 51 to 36,we conducted Study 2 for further item selection.Five hundred and thirty-one Japanese subjects,composed of 212 patients with malignancies (lung,stomach, colorectal, breast, lymphoma/leukemiaand others) and 319 patients with other benigndisease (liver disease like infectious hepatitis andcirrhosis, gastrointestinal disease like peptic ulcerand ulcerative colitis, lung disease like chronicbronchitis, emphysema and tuberculosis, and oth-ers), were outpatients or were admitted to one the13 institutions belonging to the Japanese Qualityof Life Research Group from June 1991 to October1991. After informed consent had been obtained,the 36-item questionnaire, STAI, and SDS wereadministered.

Their doctors were asked to record the informa-tion on KPS, diagnosis, and treatment for each

patient. The main objectives of Study 2 were: (1) totest feasibility of the 36-item questionnaire, and (2)to select items according to clinical validity.

To evaluate clinical validity, the method ofknown-group comparisons (Kerlinger, 1973) wasemployed. This analysis indicates the extent towhich questionnaire scores are able to discriminatebetween subgroups of patients differing in clinicalstatus. The clinical parameters employed to formmutually exclusive patient subgroups included thepatients’ status (outpatient/inpatient, cancer/non-cancer, and operable/inoperable cancer). A QOLquestionnaire should reflect improvement in pa-tients’ physical and mental status which permit theshift from inpatient to outpatient treatment (Slevinet al., 1988). One-way analysis of variance(ANOVA) was employed to test for the statisticalsignificance of group differences. Item selectionwas based on results of known-group comparisonsaccording to the patients’ state described above.

Study 3: confirming the 22-item 6ersion of thequestionnaire (QOL-ACD)

In evaluating psychometric properties for the 22items selected in Study 2, the internal consistency,construct validity by inter-scale correlations andconcurrent validity with PS, STAI, and SDS wereestimated. Factor analysis was performed using all22 items for the cancer patients used in Study 2(n=212). The internal consistency of each scalewas estimated using Cronbach’s alpha (Cronbach,1951). A value of 0.70 or greater was consideredacceptable. Construct validity was estimated by thecorrelations among the subscales from the 22items. It was hypothesized that if there was aPearson correlation coefficient of more than 0.40between scales, they were conceptually related.Concurrent validity was estimated by the correla-tions between PS, STAI, and SDS and thesubscales.

In our previous studies we learned that Japanesepatients preferred choosing answers from five dif-ferent choices (Nagata et al., 1996). Based on thisfinding, we converted eight questions that formerlyrequired a dichotomous choice to a 5-point scale;thus the 22-item questionnaire (QOL-ACD) em-ploys a 5-point scale for 21 items and for a facescale. The final analysis used 156 Japanese cancerpatients, principally those with lung, stomach andbreast cancer who were outpatients or were admit-ted to one of the 11 institutions belonging to the

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Japanese Quality of Life Research Group fromAugust 1992 to October 1992 after informed con-sent had been obtained. The results of ‘5-point’answers were compared to the of ‘dichotomous’answers. We also evaluated the reproducibility ofthe questionnaire by comparing answers at twodifferent times (morning and evening in the sameday) of the same 38 patients with gastrointestinaldisease.

RESULTS

Study 1: item selection from the 51-itemquestionnaire

The group conducted a nationwide study, ad-ministering the 51-item questionnaire to 121 inpa-tients with cancer, 62 of whom were diagnosedwith advanced disease. Of these 121 patients, 96(76%) answered all 51 questions. Five questionswere deleted from further analysis: two of whichonly applied to outpatients; two of which onlyapplied to smokers and drinkers; and one questionfor which all the patients picked the same answer.

Factor analyses were conducted on the remain-ing 46 items (n=96) in order to identify the bestsubset of items to be tested in the next study. Weselected the top five factors that had eigenvalues of1.0 or over, and in which at least two items withfactor loadings of 0.5 or over were observed. Thenumber of the items in the 1st, 2nd, 3rd, 4th, and5th factors was 14, 7, 3, 2 and 2, respectively. Itemsin one factor were independent from those in theother factors with the exception of two items. Weselected an additional ten items which showed theten highest correlation coefficients with the exter-nal standards, PS, STAI, and SDS. A total of 36items was proposed as potential items for our QOLquestionnaire and used for the second study. The15 items which were excluded were: (1) to hold hisor her regular job; (2) to do housework; (3)(having) desire for drinking alcohol; (4) (having) todesire for smoking; (5) feel nauseated; (6) havingabdominal distention; (7) discomfort to disturb hisor her daily work; (8) bed rest hours per day; (9)degree of comprehension about the goal of thetreatment; (10) communication with doctors; (11)communication with nurses; (12) trusting his or herattending physician; (13) comfort in the hospitalroom; (14) satisfaction with undergoing treatment;and (15) desire to discharge against medical advice.

Table 2. Clinical validity: known-group comparison for 22-and 36-item questionnaires

36-itemState of patients n 22-item

80.7123Outpatients without cancer 83.3Outpatients with cancer 51 81.2 83.1

77.572.388Inpatients without cancerInpatients with cancer 76.324 71.5

(operable)Inpatients with cancer 73.967 67.6

(inoperable)

75.6353Total 79.6F=16.01 F=10.65p=0.0001 p=0.0001

The clinical parameters employed to form mutually exclusivepatient subgroups included state of patients (outpatient/inpa-tient, cancer/non-cancer, and operable/inoperable cancer).The total score for the 22-item or 36-item questionnaire waslinearly transformed to the scale of maximum=100 (higherscore represents a higher level of functioning and a better levelof symptomatology).

Study 2: item selection from the 36-itemquestionnaire

The 36-item questionnaire was answered by 531patients (212 with cancer and 319 with othernon-malignant diseases; both inpatients and out-patients). Of these, 382 (71.3%) answered all thequestions, 78 (14.6%) answered all but one, 23(4.3%) answered all but two, eight (1.5%) answeredall but three, and only 45 patients (8.4%) left fouror more unanswered.

There was statistical significance between thescore of inpatient group and that of the outpatientgroup (pB0.05) for 18 items. In addition to the18 items, we selected four other questions forwhich the differences in the scores between in-patient and outpatient groups was of border-line significance and which we judged to be clini-cally important. It was found that each of these22 items belonged to each of the five factorsidentified in Study 1. Table 2 summarizes scoresaccording to state of the patients for the 22- 6s.36-item questionnaire. Both versions of the ques-tionnaire could significantly differentiate the pa-tients’ conditions.

The type of chemotherapy was classified intotwo categories: intensive chemotherapy employingcisplatin or doxorubicin and requiring inpatient

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care 6s. non-intensive chemotherapy requiringonly ambulatory care (Table 3). Both the 22- and36-item questionnaire showed better QOL scoresin non-intensive group, although the difference isnot significant. These results support the use ofthe short or 22-item questionnaire for the QOLassessment. The 14 items which we finally ex-cluded from the 36-item questionnaire to devisethe 22-item version were as follows: (1) to carryon evacuation and urination without help; (2)having a meal without help; (3) dressing andundressing without help; (4) to feel comfortablewith his or her family; (5) to consult about his orher problems professionally; (6) having family andfriends to share your emotion; (7) having any painin any part of the body; (8) to feel weak; (9) tofeel tired; (10) bowel movement; (11) chokingsensation; (12) chillness; (13) shortness of breath;and (14) uneasy sensation.

Study 3: psychometric testing for the 22 itemsselected (QOL-ACD)

Two-hundred and twelve patients had cancer.The characteristics of the patients are listed inTable 4.

By factor analysis, the top five factors describedin Study 1 were confirmed: factor 1, daily activity(items 1–6); factors 2 and 4, physical condition(items 7–11); factor 3, psychological condition(items 12–16); and factor 5, social attitude (items17–21) scales.

Results of frequency analysis (mean scores9S.D.) of the scales on the 22 items are shown inTable 5. Cronbach’s alpha coefficient for thescales, except for psychological condition, was0.70 or greater, indicating satisfactory internalconsistency.

Table 4. Patient characteristics in evaluating psychometrictesting for the 22 items selected

No. patients %Characteristic

100212Total

SexMale 135 63.7

36.377Female

AgeMean 56.7S.D. 13.1Range 18–83

ECOG PSMean 1.05S.D. 0.90

0–4Range

DiseaseLung 40 18.9

28 13.2Stomach12.7Colorectum 27

Breast 14 6.6Lymphoma/leukemia 12 5.7

9.021Other33.070Not specified

Inter-scale correlations were moderate betweendaily activity and physical condition as hypothe-sized (r=0.536) (Table 6). Psychological condi-tion was also moderately correlated with socialattitude (r=0.527). The face scale correlatedmore with psychological condition (r=0.506) andsocial attitude (r=0.492) than with daily activityand physical condition.

Expected concurrent validity with the PS,STAI, and SDS was found (Table 7). Namely, PScorrelated with daily activity (r=0.533) and phys-ical condition (r=0.497) in our QOL-ACD. Us-ing the STAI score as an external standard,correlation coefficients with psychological condi-tion, social attitude and face scale were higherthan those with daily activity and physical condi-tion. SDS score moderately correlated with all ofthe scales, including the face scale (r=0.417–0.538).

The difference in the mean score and non-re-sponse rates was not statistically significant be-tween the results from the 5-point and‘dichotomous’ answers.

For evaluation of reproducibility, we obtainedthe Spearman correlation coefficient between theanswers at two different times from the same

Table 3. Comparison of QOL scores between 22- and 36-itemquestionnaires according to treatment category

22-itemState of patients 36-itemn

78.875.6107Non-intensive chemotherapy75.970.738Intensive chemotherapy

In Study 2, 107 patients received intensive chemotherapy(cisplatin or doxorubicin), and other 38 patients receivedmoderate chemotherapy (oral 5-FU and 5%-DFUR). The totalscore for 22-item or 36-item was linearly transformed to thescale of maximum=100 (higher score represents a higherlevel of functioning and a better level of symptomatology).

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subjects. Coefficients of 17 out of 22 items wereover 0.6 (maximum=1.0). The other five itemsshowed coefficients of 0.54, 0.45, 0.44, 0.43 and0.28 (item No. 7).

These results confirmed the validity and reli-ability of the QOL-ACD.

Final 6ersion of the questionnaire

The final version of the 22-item questionnaire(QOL-ACD) is provided in the Appendix. Thesum of the item score of 1–6, 7–11, 12–16,17–21, and 22 gives the subscale score of ‘Dailyactivity’, ‘Physical condition’, ‘Psychological con-dition’, ‘Social attitude’, and ‘Face scale’, respec-tively. Similarly, the sum of the 22 item score (oreach subscale score) gives the QOL-ACD totalscore. A higher score represents a higher QOL ineach item, in each subscale score, and in totalscore.

DISCUSSION

The effort to construct this QOL questionnaire,developed through two basic surveys and analysisby three studies, enjoyed the support and partic-ipation of hundreds of patients of all ages with awide variety of disease sites and stages. A total of368 cancer patients and 319 patients with non-ma-lignant disease participated in the research. Asmentioned earlier, our purpose was to develop aQOL questionnaire suitable for assessing QOL inresponse to treatment. As a result, ‘The QOLQuestionnaire for Cancer Patients Treated withAnticancer Drugs’ (QOL-ACD) consisting of 22items was produced. After careful translation of

22 items from the QOL-ACD from Japanese toEnglish (Eguchi et al., 1993) by two linguists, wecompared each item with the FLIC and EORTC-QLQ-C33. Items 3, 10, and 15 of the QOL-ACDare similar to those in the EORTC-QLQ-C33.Reliability and validity (Donovan et al., 1989)analyses were performed on the final question-naire. The known-group comparison according toinpatient or outpatient state was assigned partic-ular importance because one of the goals of anoncology practice is to shift the chemotherapytreatment from the inpatient to the outpatientsetting. Internal consistency was verified by Cron-bach’s alpha coefficient. The results of test–retestexamination supported high reproducibility of thequestionnaire.

We designed this questionnaire with the inten-tion of broad applicability, encompassing a widevariety of disease sites and stages. Accordingly,site- and stage-specific questions were purposelyexcluded. Such questions can certainly be added,depending on site, nature of the Phase III trial,and other conditions.

We recognize the timing, frequency, and dura-tion of the interviews will, necessarily, vary ac-cording to practical and theoretical consider-ations unique to each clinical trial.

The use of the QOL-ACD should in no waypreclude the introduction of revisions and amend-ments deemed important to the conduct of aclinical trial. The goal is to monitor changes inQOL over time. Most revisions and amendmentslead to changes in treatment which impact favor-ably on QOL.

The controversial issue of ‘cancer notificat-ion’ appears likely to affect the conduct of futuretrials. Historically, cancer patients in Japan,

Table 5. Frequency analysis and Cronbach’s alpha coefficient for each scale on the 22-itemquestionnaire

Cronbach’sS.D.Scale Mean scoreItemsa

alpha

Daily activity 25.51–6 0.8216.10.730Physical condition 7–11 4.917.2

Psychological condition 12–16 18.3 4.2 0.582Social attitude 4.417.117–21 0.740

3.422 0.9Face scale —

a Numbers correspond to item numbers on the 22-item questionnaire (QOL-ACD, see theAppendix).The scale scores were calculated from unweighted.Summation of the item scores

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Table 6. Inter-scale correlation among the scales on the 22-item questionnaire

Daily Physical FacePsychological Socialcondition scaleattitudeconditionactivity

1.000Daily activity1.000 0.536Physical condition0.329 0.405 1.000Psychological condition0.355 0.447 0.527Social attitude 1.0000.258Face scale 0.385 0.506 0.492 1.000

Table 7. Concurrent validation between PS, STAI, and SDS and the scales of the 22-item questionnaire

PhysicalDaily FaceScore as external TotalPsychological Socialstandard condition conditionactivity scale scoreaattitude

PS score 0.5510.2590.2880.3040.4970.5330.6050.5650.5260.404 0.5540.216STAI score0.5140.5250.5380.5330.417 0.662SDS score

a Total score of the 22-item questionnaire.

especially those with advanced disease, have notbeen notified of their diagnosis. Diagnosis, prog-nosis, and treatment options were explained onlyto the patient’s family, and decisions were madeby the physician and patient’s family members.Although this practice is rapidly changing as thepublic begins to recognize that some early stagecancers are highly curable, the medical commu-nity in Japan remains divided regarding this is-sue.

A related issue, ‘informed consent’, also gener-ates a surprising degree of controversy amongboth medical professionals and patients. The ma-jority of Japanese lack sufficient ‘death educa-tion’, and medical professionals rarely discuss thetopics of death and prognosis with their patients.Such topics must, of course, be addressed if thegoal of true informed consent is to be attained.In order to collect data from patients, such as aQOL rating, obtaining informed consent iscritical.

In the US, Phase III trials are being evaluatednot only through objective outcomes, such asresponse rate and survival, but also by monitor-ing QOL. A recent article (Gotay et al., 1992)inspired us with their many ideas and sugges-tions as we developed this QOL questionnaire.

Gotay et al. (1992) have defined QOL as a ‘stateof well-being composed of: (1) the ability to per-form everyday activities which reflect phys-ical, psychological, and social well-being, and (2)satisfaction with levels of functioning and thecontrol of disease and/or treatment-related symp-toms’. We feel our questionnaire reflects thisdefinition of QOL.

Finally, we greatly appreciate the hundreds ofpatients who participated in, and contributed to,the effort to develop this QOL questionnaire.Their patience, courage, charity and great spirithave truly inspired us. We hope that the applica-tion of this questionnaire in future trials allowsus to design better treatments and improveoutcomes.

ACKNOWLEDGEMENTS

This work was supported by a Grant-in-Aid for CancerResearch from the Ministry of Health and Welfare, Japan. The authors thank the doctors (HiroshiOgawa, PhD, Noriaki Suzuki, MD, KunitsuguIshikawa, MD, Tomomitsu Hotta, MD, and TakeshiTominaga, MD), nurses and patients for their coopera-tion in this study.

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APPENDIX: QOL QUESTIONNAIRE FOR CANCER PATIENTS TREATED WITHANTICANCER DRUGS

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