Optimizing Prostate Cancer Care: Integrating Risks, Benefits and Patient Experiences in the New Era of Molecular Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 13
- 主要终点
- Change in Decisional Conflict Scale (DCS)
研究概览
简要总结
The purpose of this study is to examine patient experiences, health-related quality of life, and decision-making associated with PET imaging for prostate cancer. In particular, Prostate Specific Membrane Antigen (PSMA) PET, a new and more sensitive form of imaging that can help identify metastatic cancer earlier and more reliably.
详细描述
The primary objective is to measure health related quality of life among patients with prostate cancer who are undergoing prostate specific membrane positron emission tomography (PSMA-PET) imaging. This will be assessed in four domains: cancer related anxiety, decisional conflict, health related quality of life (physical functioning) and health preferences.
The secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.
Study Design Investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases. In the first phase, serial quantitative psychological (anxiety, uncertainty) and HRQoL survey data from patients undergoing PET imaging in routine clinical care will be collected. In the second phase, a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.
Patient clinical and sociodemographic data will be collected through automated extraction from the medical record (EPIC) into the REDcap database through collaboration with JDAT. For fields that are not populated via automated methods we will manually enter information via abstraction of the patient's medical record (EPIC).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of prostate cancer
- •Scheduled for their FIRST PSMA PET scan for prostate cancer
- •English-speaking
- •Willing and able to complete 4 surveys electronically or on paper at 3 timepoints (within 1 month after PET scan, 3-6 months, 12 months)
- •Able to use mobile device (smartphone or tablet) or computer with web access to complete study surveys or able to complete paper surveys
排除标准
- •Lack of access to a mobile device (smartphone or tablet) or computer with web access or unable to receive surveys by mail.
- •Unable to give consent and be enrolled
- •PET scan is being conducted within a clinical trial
结局指标
主要结局
Change in Decisional Conflict Scale (DCS)
时间窗: baseline, 3-6 months, and 12 months
A 16-item instrument using a 5-point Likert scale, ranging from 0 (strongly agree)-4 (strongly disagree), that has been widely applied to understand decision-making in prostate cancer. Higher scores indicate greater degrees of decisional conflict. DCS subscales include patient perceptions of uncertainty in choosing among treatment options, the contribution of modifiable factors (e.g., feeling uninformed), and effectiveness of decision-making (e.g., satisfaction with the choice). Total and subscale scores range from 0 to 100.
Change in Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
时间窗: baseline, 3-6 months, and 12 months
An 18-item instrument assessing frequency of anxiety in response to prostate cancer with 4 Likert responses ranging from 0 (not at all) to 3 (often); total score range 0 to 54). Higher scores indicate more anxiety.
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
时间窗: baseline, 3-6 months, and 12 months
A 26 item prostate cancer specific health-related quality of life (HRQOL) questionnaire assessing urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Change in EuroQol-5 Dimension (EQ-5D)
时间窗: baseline, 3-6 months, and 12 months
The instrument assesses five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D values can be converted to calculate health utilities that will be used for estimation of quality adjusted life years in decision analytic modeling. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales.
次要结局
- Qualitative interviews on patient experiences and perspectives on PET imaging.(baseline, 3-6 months, and 12 months)