Patients' Preferences in the Treatment of Hormone-sensitive Metastatic Prostate Cancer: a Discrete Choice Experiment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 35
- 主要终点
- Treatment attribute preferences as assessed using a study-specific think aloud interview.
研究概览
简要总结
Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.
Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival.
We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.
详细描述
OBJECTIVES: To determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mPCa). To determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies.
PHASE: Prospective multi-centre observational cohort
DESIGN: Discrete choice experiment, single-visit, electronic questionnaire design
SAMPLE SIZE: Multi-centre Stage (Stage 3) n = 300 patients
POPULATION: Men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer within 4 months of screening visit
- •Performance status 0-2
排除标准
- •Castrate-resistant metastatic prostate cancer
- •Patient has consented to a form of local cytoreductive treatment to prostate
- •Patient has consented to a form of metastasis directed therapy
结局指标
主要结局
Treatment attribute preferences as assessed using a study-specific think aloud interview.
时间窗: Through study completion, an average of 3 months [Stage 2] (Think Aloud Interview).
Qualitative work derived from "Think Aloud Interviews". Treatments include radiotherapy, surgery, ablation and metastasis directed therapy.
Willingness to accept treatment attributes, and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire
时间窗: Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). Trade-off from Marginal Rate of Substitution calculate as percentage points (0 to 100).
Utility values obtained via multinominal logit estimates from discrete choice experiment
次要结局
- Willingness to accept the potential effect sizes that are shown in trials.(Through study completion, an average of 1 year [Stage 3] (Discrete Choice Experiment (DCE) Questionnaire). No scale.)