Principal Investigator	PI Home Department	Source of Support	Dates	Total Cost
Frederick J. Meyers, M.D.	Internal Medicine Administration	National Cancer Institute	7/01/2002 -6/30/2007	$2,429,599

The specific aims of the study are to test methods that support cancer patients enrolled in clinical trials and their caregivers with improved problem-solving and decision-making skills that will help decrease patient and caregiver stress and anxiety, and improve patient/caregiver/physician communication. The study will also assess the impact of providing problem-solving education and follow-up reinforcement on critical aspects related to clinical trials participation, including accrual and retention, utilization of resources, place of death, and frequency of hospice/supportive care referral, admission and length of stay.

The Simultaneous Care Education Intervention (SCEI) team uses the COPE problem-solving educational model to instruct patients on how to problem solve and manage challenges associated not only with the investigational therapy, but also the psychosocial issues that arise from cancer diagnosis, disease progression, treatment, and disease or treatment-related symptoms. The model uses patient/family caregiver education as the vehicle to support and sustain the patient/family constellation through the clinical trial while addressing critical palliative care in advanced disease. By applying this approach to the full range of difficulties encountered in the advanced illness and clinical trials arenas, patients and families can obtain crucial treatment and support while simultaneously planning for and working through difficult decisions. The investigators anticipate that patients and family caregivers will experience reduced distress, good symptom control, and improved quality of life. In addition, we hypothesize that the enhanced communication skills of both patients and caregivers will lead to earlier identification and intervention with protocol-related complications and will promote improved recruitment and retention on clinical trials, more appropriate resource utilization, and increased frequency and duration in the use of hospice/supportive care. The funded project is innovative in that it combines two previously successful strategies for intervention - the COPE problem-solving model and the concept of Simultaneous Care (SC), palliation during clinical trial participation - in a population of patients personally or systematically denied access to similar care during participation in disease-directed therapy (DDT). The project leaders plan to disseminate the findings of the SCEI implementation and evaluation by hosting a national meeting for fifty cancer centers in the last year of the grant period in order to promote better care for patients across all cancer centers.

To date, a Palliative Care Operations Office has been established at UC Davis that manages grant activities for the study including randomizing patients at three sites to either the intervention or control arm of the study. The Operations Office has developed a database for collecting demographic information on both patients and caregivers, and for collecting data using five validated instruments at five time points.