Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 541
- 试验地点
- 3
- 主要终点
- evaluate the impact of anxiety and the inability to tolerate ambiguity
研究概览
简要总结
The purpose of this study is to collect information on how patients and their partners/close allies make treatment decisions when they have been diagnosed with early stage prostate cancer.
详细描述
Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain the patients' treatment decision (AT or AS) within approximately 6 months. Once a patient makes a decision, he and his partner will complete another set of questionnaires. The patient and his partner will then complete the remaining questionnaires approximately 6, 12, 18, and 24 months following the treatment decision. We will examine the associations between baseline assessments , and the treatment decision as well as the changes in the assessments and the treatment decision. We will also assess associations between follow-up assessments and the decision to change a treatment decision from AS to AT. Data from patients and partners/close allies will generally be analyzed separately, thus patients who do not have a partner (or partner declines to participate) can still be enrolled and their psychosocial outcomes assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 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
- 是
入选标准
- •For patients:
- •Men who meet the NCCN guidelines for low risk prostate cancer, which include all of the following:
- •Most recent Gleason score ≤ 6, or clinical stage T1a or less;
- •Most recent PSA level below 10;
- •In the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); OR the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
- •Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
- •Has not made a treatment decision prior to consent, as per self report
- •18 years of age or older
- •For partners/close allies:
- •Considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
- •Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
- •18 years old or older
排除标准
- •For patients:
- •History of a cancer other than prostate cancer and non-melanoma skin cancer
- •Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
- •For partners/close allies:
- •Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
研究组 & 干预措施
early stage prostate patients & their partners/close allies
干预措施: assessments (Behavioral)
结局指标
主要结局
evaluate the impact of anxiety and the inability to tolerate ambiguity
时间窗: 2 years
on the decision making process in men with prostate cancer who are eligible for active surveillance and their partners/close allies. All participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
次要结局
- how partners/close allies influence the decision making process(2 years)