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Titolo:
QUALITY-OF-LIFE ASSESSMENT IN PATIENTS RECEIVING ADJUVANT THERAPY FORBREAST-CANCER - THE IBCSG APPROACH
Autore:
BERNHARD J; HURNY C; COATES AS; PETERSON HF; CASTIGLIONEGERTSCH M; GELBER RD; GOLDHIRSCH A; SENN HJ; RUDENSTAM CM;
Indirizzi:
IBCSG COORDINATING CTR,EFFINGERSTR 40 CH-3008 BERN SWITZERLAND MED DIV LORY BERN SWITZERLAND AUSTRALINA NEW ZEALAND CANC TRIALS GRP SYDNEY NSW AUSTRALIA UNIV SYDNEY,DEPT CANC MED SYDNEY NSW 2006 AUSTRALIA DANA FARBER CANC INST,IBCSG STAT CTR,DEPT BIOSTAT SCI BOSTON MA 02115 EUROPEAN INST ONCOL MILAN ITALY OSPED CIV,DEPT ONCOL LUGANO SWITZERLAND KANTONSSPITAL,DEPT MED C,DIV ONCOL ST GALLEN SWITZERLAND SAHLGRENS UNIV HOSP,DEPT SURG S-41345 GOTHENBURG SWEDEN
Titolo Testata:
Annals of oncology
fascicolo: 9, volume: 8, anno: 1997,
pagine: 825 - 835
SICI:
0923-7534(1997)8:9<825:QAIPRA>2.0.ZU;2-K
Fonte:
ISI
Lingua:
ENG
Soggetto:
OF-LIFE; CLINICAL-TRIALS; EUROPEAN-ORGANIZATION; RANDOMIZED TRIAL; CHEMOTHERAPY; END; VALIDATION; INSTRUMENT; SURVIVAL; HEALTH;
Keywords:
ADJUVANT THERAPY; BREAST CANCER; CROSS-CULTURAL ISSUES; LINEAR ANALOG SELF-ASSESSMENT (LASA) SCALES; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
45
Recensione:
Indirizzi per estratti:
Citazione:
J. Bernhard et al., "QUALITY-OF-LIFE ASSESSMENT IN PATIENTS RECEIVING ADJUVANT THERAPY FORBREAST-CANCER - THE IBCSG APPROACH", Annals of oncology, 8(9), 1997, pp. 825-835

Abstract

Background and purpose. The International Breast Cancer Study Group (IBCSG) has developed an approach for assessing the impact of adjuvant therapy on quality of life (QL) within the framework of international,multilingual clinical trials. The major steps are summarized. Conceptual, methodological and practical issues are discussed with reference to results of two trials closed to accrual (IBCSG VI, VII) and one subsequent ongoing trial(IBCSG IX). Patients and methods. QL was assessedin pre-and post-menopausal patients with operable breast cancer. Various single-item linear analogue self-assessment (LASA) scales were used as indicators of components of QL, including global indicators of well-being, functioning and health perception, and specific indicators of symptoms of disease and treatment. In trials VI and VII, QL was assessed at baseline, during adjuvant treatment and follow-up, and at recurrence. Based on this experience, the QL form was revised for subsequent trials and further investigated in a subsample of patients randomized into trial IX. Results. In trials VI and VII, the QL indicators were responsive to the impact of biomedical factors at baseline, various adjuvant treatments, changes over the first 18 months, and recurrence. In trial IX, the revised QL form was well accepted by patients and staff. Completing this form did not exceed five minutes. QL differences between on and off cytotoxic treatment strengthen the claim that thesemeasures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specificindicators. Conclusion. Results from two trials closed to accrual andan ongoing trial confirm the feasibility, validity and clinical relevance of the IBCSG approach for studying the impact of adjuvant breast cancer therapy on QL in international clinical trials.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/12/20 alle ore 19:39:54