Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach

J. Bernhard, C. Hürny, A. S. Coates, H. F. Peterson, M. Castiglione-Gertsch, R. D. Gelber, A. Goldhirsch, H. J. Senn, C. M. Rudenstam

Research output: Contribution to journalArticle

59 Citations (Scopus)

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 assessed in 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 these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Conclusion: Results from two trials closed to accrual and an 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.

Original languageEnglish
Pages (from-to)825-835
Number of pages11
JournalAnnals of Oncology
Volume8
Issue number9
DOIs
Publication statusPublished - Sep 1997

Fingerprint

Quality of Life
Breast Neoplasms
Therapeutics
Clinical Trials
Recurrence
Logistic Models
Regression Analysis
Health

Keywords

  • Adjuvant therapy
  • Breast cancer
  • Cross-cultural issues
  • Linear analogue self-assessment (LASA) scales
  • Quality of life
  • Randomized controlled trials

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Bernhard, J., Hürny, C., Coates, A. S., Peterson, H. F., Castiglione-Gertsch, M., Gelber, R. D., ... Rudenstam, C. M. (1997). Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach. Annals of Oncology, 8(9), 825-835. https://doi.org/10.1023/A:1008269715091

Quality of life assessment in patients receiving adjuvant therapy for breast cancer : The IBCSG approach. / Bernhard, J.; Hürny, C.; Coates, A. S.; Peterson, H. F.; Castiglione-Gertsch, M.; Gelber, R. D.; Goldhirsch, A.; Senn, H. J.; Rudenstam, C. M.

In: Annals of Oncology, Vol. 8, No. 9, 09.1997, p. 825-835.

Research output: Contribution to journalArticle

Bernhard, J, Hürny, C, Coates, AS, Peterson, HF, Castiglione-Gertsch, M, Gelber, RD, Goldhirsch, A, Senn, HJ & Rudenstam, CM 1997, 'Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach', Annals of Oncology, vol. 8, no. 9, pp. 825-835. https://doi.org/10.1023/A:1008269715091
Bernhard J, Hürny C, Coates AS, Peterson HF, Castiglione-Gertsch M, Gelber RD et al. Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach. Annals of Oncology. 1997 Sep;8(9):825-835. https://doi.org/10.1023/A:1008269715091
Bernhard, J. ; Hürny, C. ; Coates, A. S. ; Peterson, H. F. ; Castiglione-Gertsch, M. ; Gelber, R. D. ; Goldhirsch, A. ; Senn, H. J. ; Rudenstam, C. M. / Quality of life assessment in patients receiving adjuvant therapy for breast cancer : The IBCSG approach. In: Annals of Oncology. 1997 ; Vol. 8, No. 9. pp. 825-835.
@article{28e97c98b3fe45cc9a7c16825ffe2108,
title = "Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach",
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 assessed in 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 these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Conclusion: Results from two trials closed to accrual and an 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.",
keywords = "Adjuvant therapy, Breast cancer, Cross-cultural issues, Linear analogue self-assessment (LASA) scales, Quality of life, Randomized controlled trials",
author = "J. Bernhard and C. H{\"u}rny and Coates, {A. S.} and Peterson, {H. F.} and M. Castiglione-Gertsch and Gelber, {R. D.} and A. Goldhirsch and Senn, {H. J.} and Rudenstam, {C. M.}",
year = "1997",
month = "9",
doi = "10.1023/A:1008269715091",
language = "English",
volume = "8",
pages = "825--835",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "NLM (Medline)",
number = "9",

}

TY - JOUR

T1 - Quality of life assessment in patients receiving adjuvant therapy for breast cancer

T2 - The IBCSG approach

AU - Bernhard, J.

AU - Hürny, C.

AU - Coates, A. S.

AU - Peterson, H. F.

AU - Castiglione-Gertsch, M.

AU - Gelber, R. D.

AU - Goldhirsch, A.

AU - Senn, H. J.

AU - Rudenstam, C. M.

PY - 1997/9

Y1 - 1997/9

N2 - 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 assessed in 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 these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Conclusion: Results from two trials closed to accrual and an 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.

AB - 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 assessed in 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 these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Conclusion: Results from two trials closed to accrual and an 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.

KW - Adjuvant therapy

KW - Breast cancer

KW - Cross-cultural issues

KW - Linear analogue self-assessment (LASA) scales

KW - Quality of life

KW - Randomized controlled trials

UR - http://www.scopus.com/inward/record.url?scp=0030827706&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030827706&partnerID=8YFLogxK

U2 - 10.1023/A:1008269715091

DO - 10.1023/A:1008269715091

M3 - Article

C2 - 9358933

AN - SCOPUS:0030827706

VL - 8

SP - 825

EP - 835

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 9

ER -