The primary hypothesis of this study is that the effects of primary treatment or active surveillance on outcomes reported by prostate cancer patients and their partners, including quality of life and uncertainty, are modified by patient and treatment characteristics which consequently determine patient and spouse satisfaction with overall cancer care outcome. We have accrued and completed 2 year follow-up of 1826 prostate cancer patients and partners (Cohort 1) that had been proposed to address Aims of the first funding cycle. We identified baseline determinants of post-treatment HRQOL and Satisfaction with outcome among patients and their partners. We conducted preliminary studies (in a separate cross-sectional cohort at one of the consortium sites) which showed that further changes in HRQOL are anticipated in the next 5 years of follow-up for the prospective, multicenter Cohort 1 participants. We assembled evidence from the Physician?s Health Study that Active Surveillance, may be associated with benefits in some prostate HRQOL domains but detriment in other domains. We developed and pilot-tested an intervention to mitigate patient uncertainty during Active Surveillance. Our preliminary findings support the following Specific Aims: 1) To measure the long-term consequences of primary prostate cancer treatment on patient-reported outcomes and to relate these to baseline, pretreatment patient characteristics, cancer severity and treatment factors and to determine the effects cancer recurrence and consequent salvage treatment on HRQOL and satisfaction with care outcome reported by patients and spouses or partners. 2) To evaluate the determinants of satisfaction with care, HRQOL, and perception of uncertainty or danger among subjects undergoing active surveillance. 3) To test whether the Uncertainty Management Intervention for Active Surveillance (UMI-AS) will reduce progression of patients from active surveillance to primary treatment, and improve satisfaction with cancer care among patients and their spouses or partners.
The first Aim will be accomplished through continued follow-up of 1201 patients and 625 spouse partners that was assembled during the first cycle of funding. The second and third Aims will be addressed in a new cohort (Cohort 2) of 1080 patients undergoing active surveillance or treatment and 540 spouses that will be accrued during the newly proposed period of funding.
The third Aim will focus on a randomized study evaluating the counseling intervention specifically among the active surveillance subset of Cohort 2. Completion of the proposed studies will better enable patients and their partners to anticipate outcomes of early stage prostate cancer care, and to reduce uncertainty and perception of danger related to the cancer. In so doing, our findings will facilitate appropriately individualizing decision making based on unique characteristics of each prostate cancer patient and his partner.
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