Grant Number:	5R01MH047226-10 Interpret this number
Primary Investigator:	Spiegel, David
Organization:	Stanford University
Project Title:	Psychosocial Treatment Effects on Cancer Survival
Fiscal Year:	1999

The goal of this study is to examine the psychological and physiological effects of a group psychotherapy intervention for metastatic breast cancer patients. There is evidence that this treatment enhances coping and social support, reduces mood disturbance and pain, and may extend survival time. The current randomized, prospective study is designed to replicate these findings and assess specific physiological mechanisms associated with survival time. The study was initiated in 1990 and would be completed during the next grant period. The specific aims of the study are: 1. To study the effect of group psychotherapy on survival time of patients with metastatic breast carcinoma. Our primary hypothesis is that participation in supportive/expressive group psychotherapy will be associated with longer survival time. This has been observed in our own and two other randomized trials with cancer patients. 2. To assess the physiological basis of psychosocial effects on survival. The next important question is which mediating mechanisms are influenced by psychosocial intervention and may also affect the rate of disease progression. This study is designed to assess four such mechanisms: a) health behaviors; b) health care utilization; c) endocrine function; and, d) immune function. We are measuring salivary cortisol, a stress-responsive and immunosuppressive hormone. Our immune measures include the function and number of cytotoxic t-cells (natural killer cells), the number of helper (CD4) and suppressor (CD8) T cells, total T cells (CD3), total white blood cell counts, and the cellular response to subcutaneously injected antigens (delayed-type hypersensitivity). We hypothesize that lower cortisol levels and higher immune activity, especially natural killer cell cytotoxicity, will result from group therapy and will predict longer survival. 3. To examine psychosocial effects of group treatment, including anxiety, depression and pain. 4. To determine pre-existing psychosocial and physiological variables that are predictors of survival time. 5. To determine the relationship between changes in psychosocial variables and survival time. 6. To study the effects of group therapy on health care utilization and costs. We have a unique opportunity to obtain definitive answers to these questions because with NIMH and NCI support which commenced in 1990, we have implemented a randomized prospective trial of group psychotherapy for breast cancer patients. Ninety-seven women have been enrolled in the study to date, and we will recruit an additional 31 by the end of this year. Half are assigned to weekly supportive/expressive group psychotherapy plus education, half to education alone. We plan to obtain at least 4.5 year follow-up on all subjects during the next grant period. The results of this study have the potential to alter the standard of psychosocial and medical care of advanced breast cancer patients, and provide important new directions for research on the interaction of mind and body in cancer progression and treatment.