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Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer.

ABSTRACT: Men diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group.English/Spanish-speaking men diagnosed with LPC (2007-2009) from four US cities were enrolled into a randomized trial and followed through 6-months via mailed or online questionnaire. Men were randomized to receive the P3P intervention or standard education plus links to reputable websites. We classified choice as concordant if men were concerned with (a) sexual function and chose external beam radiotherapy or brachytherapy, (b) bowel function and chose prostatectomy, (c) sex, bowel, and/or bladder function and chose active surveillance, or (d) not concerned with any side effect and chose any treatment. Using logistic regression, we calculated odds ratios (OR) and 95% confidence intervals (CI) for the association between the P3P intervention and concordance.Of 448 men, most were <65 years, non-Hispanic white, had multiple physician consultations prior to enrollment, and chose a treatment discordant with concerns about potential side effects. There was no significant difference in concordance between the intervention (45%) and control (50%) group (OR?=?0.82; 95%CI?=?0.56, 1.2).The P3P intervention did not improve concordance between potential side effects and treatment choice. Information and/or physician consultation immediately after diagnosis was likely to influence decisions despite concerns about side effects. The intervention may be more effective before the first treatment options consultation.NCT00692653 http://clinicaltrials.gov/ct2/show/NCT00692653.

SUBMITTER: Bosco JL

PROVIDER: S-EPMC3502193 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature

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Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer.

Bosco Jaclyn L F JL Halpenny Barbara B Berry Donna L DL

Health and quality of life outcomes 20120928

<h4>Background</h4>Men diagnosed with localized prostate cancer (LPC) can choose from multiple treatment regimens and are faced with a decision in which medical factors and personal preferences are important. The Personal Patient Profile-Prostate (P3P) is a computerized decision aid for men with LPC that focuses on personal preferences. We determined whether the P3P intervention improved the concordance of treatment choice with self-reported influential side-effects compared with a control group ...[more]

PMID: 23021156

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Project description:ImportanceProstate radiation therapy (PRT) is a treatment option in men with low-volume metastatic prostate cancer based on the results of the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy Arm H (STAMPEDE-H) trial. However, the cost-effectiveness of this treatment remains unaddressed.ObjectiveTo assess the cost-effectiveness of PRT when added to androgen deprivation therapy (ADT) for men with low-volume metastatic hormone-sensitive prostate cancer (mHSPC).Design, setting, and participantsThis economic evaluation used microsimulation modeling to evaluate the cost-effectiveness of adding PRT to ADT. A simulated cohort of 10 000 individuals with low-volume mHSPC was created. Data from men with low-volume mHSPC were extracted and analyzed from January 18, 2019, through July 4, 2020. Transition probabilities were extracted from the STAMPEDE-H study. Health states included stable disease, progression, second progression, and death. Individual grade 2 or higher genitourinary and gastrointestinal toxic events associated with PRT were tracked. Univariable deterministic and probabilistic sensitivity analyses explored uncertainty with regard to the model assumptions. Health state utility estimates were based on the published literature.ExposuresThe combination of PRT and ADT using regimens of 20 fractions and 6 weekly fractions.Main outcomes and measuresOutcomes included net quality-adjusted life-years (QALYs), costs in US dollars, and incremental cost-effectiveness ratios. A strategy was classified as dominant if it was associated with higher QALYs at lower costs than the alternative and dominated if it was associated with fewer QALYs at higher costs than the alternative.ResultsFor the base case scenario of men 68 years of age with low-volume mHSPC, the modeled outcomes were similar to the target clinical data for overall survival, failure-free survival, and rates of PRT-related toxic effects. The addition of PRT was a dominant strategy compared with ADT alone, with a gain of 0.16 QALYs (95% CI, 0.15-0.17 QALYs) and a reduction in net costs by $19 472 (95% CI, $23 096-$37 362) at 37 months of follow-up and a gain of 0.81 QALYs (95% CI, 0.73-0.89 QALYs) and savings of $30 229 (95% CI, $23 096-$37 362) with lifetime follow-up.Conclusions and relevanceIn the economic evaluation, PRT was a dominant treatment strategy compared with ADT alone. These findings suggest that addition of PRT to ADT is a cost-effective treatment for men with low-volume mHSPC.

Project description:OBJECTIVE:The purpose of this trial was to compare usual patient education plus the Internet-based Personal Patient Profile-Prostate, vs. usual education alone, on conflict associated with decision making, plus explore time-to-treatment, and treatment choice. METHODS:A randomized, multi-center clinical trial was conducted with measures at baseline, 1-, and 6 months. Men with newly diagnosed localized prostate cancer (CaP) who sought consultation at urology, radiation oncology, or multi-disciplinary clinics in 4 geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using generalized estimating equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice, and program acceptability/usefulness, were explored. RESULTS:A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time compared with the control group, for the uncertainty score (estimate -3.61; (confidence interval, -7.01, 0.22), and values clarity (estimate -3.57; confidence interval (-5.85,-1.30). Borderline effect was seen for the total decisional conflict score (estimate -1.75; confidence interval (-3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION:The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized CaP. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a CaP treatment that is consistent with the patient values and preferences.

Project description:IntroductionIn the USA, African American men bear a disproportionate burden of prostate cancer (PCa) compared with all other groups, having a higher incidence and mortality, poorer quality of life and higher dissatisfaction with care. They are also less likely to receive guideline-concordant treatment (eg, undertreatment of aggressive disease). Inadequate patient-provider communication contributes to suboptimal care, which can be exacerbated by patients' limited health literacy, providers' lack of communication skills and time constraints in low-resource, safety net settings. This study is designed to examine the communication experiences of African American patients with PCa as they undertake treatment decision-making.Methods and analysisUsing an ethnographic approach, we will follow 25 African American men newly diagnosed with PCa at two public hospitals, from diagnosis through treatment decision. Data sources include: (1) audio-recorded clinic observations during urology, radiation oncology, medical oncology and primary care visits, (2) field notes from clinic observations, (3) patient surveys after clinic visits, (4) two in-depth patient interviews, (5) a provider survey, and (6) in-depth interviews with providers. We will explore patients' understanding of their diagnoses and treatment options, sources of support in decision-making, patient-provider communication and treatment decision-making processes. Audio-recorded observations and interviews will be transcribed verbatim. An iterative process of coding and team discussions will be used to thematically analyse patients' experiences and providers' perspectives, and to refine codes and identify key themes. Descriptive statistics will summarise survey data.Ethics and disseminationTo our knowledge, this is the first study to examine in-depth patient-provider communication among African American patients with PCa. For a population as marginalised as African American men, an ethnographic approach allows for explication of complex sociocultural and contextual influences on healthcare processes and outcomes. Study findings will inform the development of interventions and initiatives that promote patient-centred communication, shared decision-making and guideline-concordant care. This study was approved by the University of California San Francisco and the Alameda Health System Institutional Review Boards.

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Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer.

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Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer.

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