PERSONAL PATIENT PROFILE PROSTATE (P4) - A RANDOMIZED, MULTI-SITE TRIAL

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: To compare the primary decisional outcomes in men receiving traditional patient education strategies plus the P4 Program vs. traditional patient education strategies alone at one and six months in a diverse sample of men with localized prostate cancer with regard to: decisional conflict measured by the Decisional Conflict Scale, perceived preparation for the treatment decision measured by the Satisfaction with Preparation for Decision-Making Scale and decisional satisfaction measured by the Satisfaction with Decision Scale. RESEARCH PLAN: Men with a biopsy-proven diagnosis of prostate cancer, Stage I or II within the last six months who have not begun therapy will be invited to take part in the study at the time the are given the diagnosis of prostate cancer. They will be given a choice of accessing the P4 program from their home computer or from a private area on the GCRC. The subject has the opportunity to view video clips modeling interactions of his informtaion priorities ranking, read about level of participation in the decision, read about potential complications and link to reliable, outside Internet resources. The results of the information priorities, the control preference and the influential factors summary are automatically printed for him. The Control group program ends with an on-screen and print-available list of two websites, thank-you's and team names after the query component is concluded. Both groups receive follow-up questions occurring at 1 and 6 months. METHODS: Assuming a two-sided type I error probability of 0.05, a sample size of 214 subjects per arm will give us power at 90% to detect a significant difference between intervention and control group scores. Participant demographic data for both groups will be summarized with descriptive statistics and examined for group comparability. Statistical significance will be considered p<.05. We will explore the differences between the groups with regard to change in decisional control preferences from pre-decision to post-treatment measured by a modified Control Preferences Scale. Resource utilization as measured by the Amount of Clinician Contact query will be compared between groups. Selected sociodemographic characteristics will not only be used to describe the sample, but will be used as vairables along with influential factors and symptoms. Based on our preliminary work we anticipate that the data will indicate significant correlations between influential personal factors, sociodemographic characteristics and other outcome vairables of interest. Additionally, the information sources used may vary by ethnicity. CLINICAL RELEVANCE: This new program provides a fresh approach to patient education and support with a) the understanding and computerized assessment of influential personal factors involved in the decisions; and b) computerized decisional control and information preference assessment. Combining the power of current health informatics technology to instantaneously synthesize input and generate a tailored intervention with the accessibility of Internet access both at the point-of-service in a urologic cancer clinic and in the community, this unique decision support system could transform localized prostate cancer treatment decision making.