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.
OBJECTIVE
To evaluate the effect of a standardized group psychosocial intervention on health-related quality of life (HrQOL) in women with metastatic breast cancer and to explore the effect of missing data in HrQOL analyses.


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. HrQOL 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 HrQOL information (n = 215).


RESULTS
Baseline EORTC QLQ-C30 scores were not different between the two study arms (all P >.05). Primary analysis of all subscales failed to show a significant influence of the intervention on 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 HrQOL using a variety of approaches to handling missing data.


CONCLUSIONS
Supportive-expressive group therapy in patients with metastatic breast cancer does not appear to influence HrQOL, as measured by the EORTC QLQ-C30.
Department of Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada M5G 1X5. lbordeleau@mtsinai.on.ca
Louise
L
Bordeleau
John Paul
JP
Szalai
Marguerite
M
Ennis
Molyn
M
Leszcz
Michael
M
Speca
Rami
R
Sela
Richard
R
Doll
Harvey M
HM
Chochinov
Margaret
M
Navarro
Andrew
A
Arnold
Kathleen I
KI
Pritchard
Andrea
A
Bezjak
Hilary A
HA
Llewellyn-Thomas
Carol A
CA
Sawka
Pamela J
PJ
Goodwin
D001943:Breast Neoplasms / Q000473:pathology / Q000523:psychology*; D002170:Canada; D003625:Data Collection; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D011615:Psychotherapy, Group; D011788:Quality of Life; D011795:Surveys and Questionnaires / Q000592:standards