title: Pitfalls in quality-of-life assessment: lessons from a Southwest Oncology Group breast cancer clinical trial.
abstract: There is increasing interest in evaluating the impact of cancer treatment and medical intervention on patient quality of life (QOL). This article reports the findings of a substudy that incorporated the Functional Living Index--Cancer in an ongoing adjuvant breast cancer clinical trial sponsored by the Southwest Oncology Group. The companion study had to be terminated prior to the end of the two-armed, randomized trial because of poor reporting rates over time. Problems with missing data items also occurred. Poor reporting rates in this trial motivated several recommendations for conducting QOL assessment in the cooperative group setting: (a) build support for QOL assessment among the group's leadership, (b) involve physicians and oncology nurses in the study design, (c) identify a QOL liaison at each participating institution, and (d) aggressively monitor the quality and timeliness of data submission.
authors.affiliation: University of Arkansas for Medical Sciences, Little Rock.
authors.forename: K A
authors.initials: KA
authors.lastname: Hayden
authors.forename: C M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: B
authors.initials: B
authors.lastname: Metch
authors.forename: P
authors.initials: P
authors.lastname: Feigl
authors.forename: R M
authors.initials: RM
authors.lastname: O'Bryan
authors.forename: S
authors.initials: S
authors.lastname: Green
authors.forename: C K
authors.initials: CK
authors.lastname: Osborne
mesh_terms: D000203:Activities of Daily Living; D001291:Attitude of Health Personnel; D001943:Breast Neoplasms / Q000451:nursing / Q000503:physiopathology / Q000523:psychology* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003625:Data Collection / Q000592:standards*; D005260:Female; D006801:Humans; D008408:Mastectomy; D009730:Nursing Assessment; D010348:Patient Care Team; D011786:Quality Control; D011788:Quality of Life; D012108:Research Personnel / Q000523:psychology*