Grant Number:	1R21CA114547-01A2 Interpret this number
Primary Investigator:	Eller, Lucille
Organization:	Rutgers The State Univ Of Nj Newark
Project Title:	Intervention to Enhance Quality of Life in Men with Pca: Development and Testing
Fiscal Year:	2007

DESCRIPTION (provided by applicant): The intent of this proposed study is to develop a targeted intervention, with individually tailored elements, and pilot test its effects on prostate cancer (PCa) related physical symptoms, anxiety, depressive symptoms, salivary cortisol (a physiological indicator of psychological distress), and quality of life (physical, functional and emotional well-being). Participants include men who will receive brachytherapy (IMRT+HDR or IMRT+seed implantation), which is the fastest growing treatment for PCa, or radical prostatectomy (RP), the most common treatment. Specific aims are to (1) conduct focus groups with men currently undergoing or who completed treatment for PCa with IMRT+HDR, IMRT+seed implantation, or RP, (2) develop an efficacy-enhancing self-care intervention based on focus group data, (3) pilot the intervention with 60 men: n=30 in the intervention group and n=30 controls, (4) estimate effect size of the intervention, (5) assess feasibility of recruitment, attrition and reported causes, number of data collection points, participation in focus groups, fidelity of the intervention, adherence to the intervention, and diffusion of the intervention. The three-stage, repeated measures experimental design incorporates qualitative and quantitative methods. Stage 1: Focus groups will be held to determine self-care behaviors used by men undergoing treatment for PCa. Stage 2: An efficacy-enhancing self-care intervention, guided by self-efficacy theory, will be developed using Stage 1 data. The intervention will include: 1) a video which will provide modeling/ visualization of performance accomplishments, to be delivered face-to-face (first dose) and with personal DVD players for participant-selected booster doses, 2) a Self-care Behaviors booklet describing potential self-care behaviors, and 3) goal setting and contracting with the intervener for the use of participant-selected self-care behaviors, and verbal persuasion and normalization of the symptom experience provided by the intervener. Stage 3: The efficacy-enhancing intervention will be tested and compared with an attention control group. Data collection will occur at baseline (prior to participant's treatment for PCa), one and six months post-intervention. Prostate cancer (PCa) is the most common cancer in men in the United States. Improved diagnosis and treatment have led to increased survival rates. However, survival is marred by physical and psychological symptoms that result in poor quality of life. The proposed efficacy-enhancing self-care intervention will address these symptoms, and has the potential to improve the quality of life of this population





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