title: 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.
abstract: 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.
authors.affiliation: Medical Division Lory Inselspital, Bern, Switzerland.
authors.forename: C
authors.initials: C
authors.lastname: Hürny
authors.forename: J
authors.initials: J
authors.lastname: Bernhard
authors.forename: A
authors.initials: A
authors.lastname: Coates
authors.forename: M
authors.initials: M
authors.lastname: Castiglione
authors.forename: H F
authors.initials: HF
authors.lastname: Peterson
authors.forename: R D
authors.initials: RD
authors.lastname: Gelber
authors.forename: C M
authors.initials: CM
authors.lastname: Rudenstam
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: H J
authors.initials: HJ
authors.lastname: Senn
mesh_terms: 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