|Grant Number:||5R01CA090739-05 Interpret this number|
|Primary Investigator:||Northouse, Laurel|
|Organization:||University Of Michigan|
|Project Title:||Prostate Cancer-Family Care for Patients and Spouses|
DESCRIPTION: Prostate Cancer: Family Care for Patients and Spouses Prostate cancer is the most common cancer among men in the United States. Treatments for prostate cancer are often accompanied by devastating complications such as sexual impotence, urinary incontinence, and bowel dysfunction that can severely affect the quality of life of men and their spouses. The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life of men with prostate cancer and their spouses. There are two specific aims for this study. The first aim is to determine if the family-based intervention can improve proximal clinical outcomes (better family communication, higher self-efficacy, more problem-focused coping, and less threat, uncertainty, and hopelessness) and improve the distal clinical outcome, better quality of life, in a culturally and socioeconomically diverse sample of men with prostate cancer and their spouses. The second aim is to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at increased risk of poorer long-term quality of life. The model includes antecedent, mediating, and outcome variables. The specific aims will be accomplished with a longitudinal, randomized-block clinical trial in which a cohort of men with prostate cancer and their spouses (N=222 dyads) will be followed over a 12 month period of time. Dyads will be stratified by three phases of illness: 1) newly diagnosed-localized phase, following prostatectomy or radiation therapy, 2) post-primary treatment phase with rising PSA (biochemical recurrence), and 3) advanced/metastatic phase with evidence of disease progression; and by type of treatment received. Following stratification, dyads will be randomized to the control (standard care) or experimental group (standard care plus FOCUS Program). The FOCUS Program is administered in three face-to-face home visits and two follow-up phone calls and provides core content in five areas: Family involvement, Optimistic attitude, Coping effectiveness, Uncertainty reduction, and Symptom management. The program also has tailored content related to phase of illness and treatment received. Data will be collected four times: baseline, prior to the intervention (Time 1); 4 months, shortly after the completion of the intervention (Time 2); 8 months (Time 3); and 12 months (Time 4) with a set of established standardized instruments. The main analysis to meet Aim 1(test of the intervention) will be the MANOVA approach to repeated measures ANOVA (intervention x time), and the main analysis for Aim 2 will use manifest variable structural equation modeling. Overall, this study will test the effectiveness of a family-based program of care in improving clinical outcomes, and test the ability of a model to predict which patients and spouses are at increased risk of poorer quality of life.