跳至主要内容
临床试验/NCT02451345
NCT02451345已完成不适用

Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive vs Indolent Prostate Cancer (Aim 2A)

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2015年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
4
主要终点
Decision Quality measured using the Decision Quality Index

研究概览

简要总结

A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and uncertainty, thereby increasing appropriate uptake of active surveillance and reducing over-treatment of low-risk prostate cancer.

This study involves: completion of questionnaires through the secure website; consultation by a health coach to aid men with prostate cancer in making informed treatment decision (personalized coaching session(s)).

详细描述

A UCSF PI-initiated study which includes comprehensive decision support intervention that may incorporate clinical, lifestyle, tumor genomic, and germline gene variant data.

The web and coaching intervention will: 1) summarize key prognostic data elements, 2) communicate relative and absolute risks of upgrading/upstaging based on each of these elements, individually and in aggregate, and 3) provide tailored educational information for informed decision making on treatment options. A key aspect of the intervention will be provision of tiered coaching to the men prior to their physician visits to help them enter information accurately into the system, understand the results of the prediction model, document their questions for their physicians, and prepare them to make better-informed treatment decisions. UCSF research team will develop the decision support intervention in phases, initially using only clinical variables, BMI (body mass index), and smoking data;and then extend it to include information from genomic and genetic inputs, as validation work progresses. Variables will be retained based on statistical evaluation of the predictive values.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • men with missing data on PSA, stage, Gleason, or extent of biopsy core involvement; no baseline (diagnostic) biopsy or germline DNA sample for research; or no follow-up pathology (from biopsy or RP) after diagnosis.
  • men unable to consent, prisoners, those with ECOG performance status >2, or psychiatric illness/social situations that would limit compliance with study requirements, or inability to read English or Spanish.

结局指标

主要结局

Decision Quality measured using the Decision Quality Index

时间窗: 12 months

measured using the Decision Quality Index

次要结局

  • Prostate Cancer Specific Anxiety measured using MAXPC survey(12 months)
  • Decision Self- Efficacy measured using Decision Self-Efficacy survey(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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