In spite of the detrimental effects that advanced cancer has on patients and their family caregivers, there are few programs of care to assist them. The purpose of this study is to determine if a brief or extensive family-based program of care (The FOCUS Program) can improve the proximal and distal outcomes of patients with advanced cancer and their family caregivers. There are two specific aims.
Aim one is to determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care. Proximal outcomes are less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, more active coping, better family illness communication, and higher self-efficacy. Distal outcomes are higher quality of life, greater satisfaction with care, and similar or lower health care resource utilization.
Aim two is to determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's risk for distress. A longitudinal randomized clinical trial will be used in which a cohort of patients with advanced cancer (breast, colon, lung, prostate) and a family caregiver (N=324 dyads) will be followed over 6 months. Patients will be assessed for risk for distress at baseline and designated as either high or low risk. Following assessment, patients and caregivers (as a dyad) will be stratified by patients' type of cancer and treatment and randomly assigned to one of three arms: 1) Usual care, 2) Brief FOCUS-three sessions, or 3) Extensive FOCUS-six sessions. Data will be collected at baseline, prior to intervention (Time 1); at three months (Time 2); and at six months (Time 3) with established instruments. Analyses will use ANCOVA with planned contrasts with three levels of care (Usual, Brief, Extensive) and two levels of risk (high and low). Overall, this study will examine intervention effects in dyads facing advanced cancer, in conjunction with program dose and patients' baseline risk for distress.
