Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: Overall effects of the intervention and an exploration of missing data

Purpose: To evaluate the effect of a standardized group psychosocial intervention an health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses. Patients and Methods. Between 1993 and 1998, seven Canadian centers randomly assigned 235 eligible women to participate in a weekly, 90-minute, therapist-led support group that adhered to principles of supportive-expressive (SE) therapy or to a control arm (no SE). All women received educational material and any type of medical or psychosocial care deemed necessary. WOOL data were prospectively collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) at baseline, 4, 8, and 12 months. The primary HrQOL analyses compared scores in the two study arms. Analyses were limited to women with appropriate baseline WOOL information (n = 215). Results: Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P > .05). primary analysis of all subscates failed to show a significant influence of the intervention an HrQOL (all P > .05). There was a significant deterioration over time in several functional scales of the EORTC QLQ-C30: global (P = .03), physical (P = .0002), role (P = .01), and cognitive functioning (P = .04); and in symptom scales: dyspnea (P = .007), appetite loss (P = .04), and fatigue (P = .003); these changes were independent of randomization allocation. Results were similar in additional analyses of overall WOOL using a variety of approaches to handling missing data. Conclusion: Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence WOOL, as measured by the EORTC QLQ-C30. (C) 2003 by American Society of Clinical Oncology.