Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in cytokine response as assessed by urine samples
研究概览
简要总结
The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.
详细描述
Patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical treatments are eligible to participate in this study. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each induction intravesical treatment. During the 6-week induction intravesical treatment, participants will also be given a daily mood dairy to complete. Urine Specimens will be collected prior to each induction intravesical treatment and at each 3-month cystoscopy appointment during the treatment course. An at home urine collection may occur 6 hours post intravesical treatment. Research Blood Samples will be collected prior to the first induction intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy as indicated by the participant's treatment course. Participants will be asked to complete the Zung Self-Rating Anxiety Scale and Zung Self-Rating Depression Scale prior to each 3-month follow-up cystoscopy during the treatment course. A 3-week daily mood diary will be completed by participants during the 3-week intravesical maintenance treatment. Participants will be given a daily mood diary to complete between the 3-month follow-up cystoscopy appointments.
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
- •Subjects with a pathologically confirmed non-muscle invasive bladder cancer
- •Age ≥ 18 years old
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.
- •Patients who are pregnant
结局指标
主要结局
Change in cytokine response as assessed by urine samples
时间窗: Prior to each 6-week intravesical treatment and every 3-month Cystoscopy for 24 months
Collect urine samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Change in cytokine response as assessed by blood samples
时间窗: Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to the each 3-month follow-up cystoscopy
Collect blood samples from the patients with non-muscle invasive bladder cancer who are undergoing intravesical instillations for cytokine response to treatment
Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale
时间窗: Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit
Screen for mood disorders in patients diagnosed with Non-muscle Invasive Bladder Cancer at baseline and while undergoing treatment utilizing the Zung Self Rating Depression Scale. The Zung Self-Rating Depression Scale has the following score ranges: Normal Range (25-49), Mildly Depressed (50-59), Moderately Depressed (60-69), Severely Depressed (70 and above)
次要结局
- Evaluate DNA and RNA-based liquid biopsy biomarkers and correlate them with tissue response(Prior to the first intravesical treatment, prior to the fourth intravesical treatment, and prior to each 3-month follow-up cystoscopy)
- Screening for Mood Disorders utilizing the Zung Self Rating Anxiety Scale(Prior to each induction intravesical treatment for six weeks and each 3-month surveillance visit)
- Screening for Mood Disorders utilizing daily mood diaries(Daily mood diary for 6-week induction intravesical treatment course, daily mood diary for 3-week intravesical treatment maintenance course, and daily mood diary between 3-month follow up cystoscopy appointments)