Timing of baseline quality of life assessment in an international adjuvant breast cancer trial: its effect on patient self-estimation. The International Breast Cancer Study Group.
BACKGROUND
Variability in timing of baseline quality of life (QL) assessments in two ongoing International Breast Cancer Study Group (IBCSG) randomized clinical trials occurred as a result of allowing some flexibility in the timing. This retrospective report describes the QL timing in relation to surgery and start of adjuvant therapy and its effect on QL self-estimation.


METHODS
Self-administered measures of baseline QL were obtained on day 1 of adjuvant therapy or as close to that date as possible from 1389 pre- and post-menopausal women with operable breast cancer.


RESULTS
Fifty-four percent of QL assessments were done on day 1 of adjuvant therapy, 18% before day 1 and 28% after. An ANOVA, controlling for surgery, institution and language, showed that: for patients receiving endocrine therapy alone, QL improved as time from surgery increased, but start of adjuvant treatment had no effect, while for chemotherapy patients, appetite, physical well-being and, in pre-menopausal patients, coping were worse 1 to 5 days after the start of treatment. Chemotherapy had little effect on mood and emotional well-being.


CONCLUSIONS
Timing of QL assessment in relation to diagnosis affects global adjustment measures; timing in relation to chemotherapy affects measures sensitive to toxicity. Timing is an important consideration in study conduct and data analysis.
Hürny
C
C
Medical Division Lory Inselspital, Bern, Switzerland.
Bernhard
J
J
Coates
A
A
Castiglione
M
M
Peterson
H F
HF
Gelber
R D
RD
Rudenstam
C M
CM
Goldhirsch
A
A
Senn
H J
HJ
D000328:Adult; D000704:Analysis of Variance; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D015986:Confounding Factors, Epidemiologic; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors