Evaluation of Mood Disorders in Bladder Cancer Patients and Their Primary Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9
研究概览
简要总结
This is a cross-sectional study evaluating mood disorders in bladder cancer patients and their caregivers across the bladder cancer trajectory
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
- •Patients or caregiver of patient with a histologic diagnosis of bladder cancer of the following subtypes, urothelial carcinoma, adenocarcinoma, or squamous cell carcinoma, within 24 months of survey administration and received treatment at the University of Kansas Health System
- •≥ 18 years of age
- •Have a patient-designated primary informal/family caregiver
- •Able to speak and read English
- •Willing and able to provide informed consent
- •Functioning telephone number or access to one
排除标准
- •Patients or caregivers of patients with metastatic bladder cancer
- •Patients who are unable to designate a primary caregiver
- •Patients and caregivers who do not both consent to study participation
结局指标
主要结局
Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9
时间窗: Data will be assessed through study completion, on average one year
Assessed using Patient-Health Questionnaire-9. A standard questionnaire with 9 questions. Score 5-9 is minimal symptoms, 10-14 is minor depression, 15-19 is major depression moderately severe, and 20-27 is severe major depression.
Severity of anxiety in bladder cancer patients and their caregivers: Generalized Anxiety Disorder-7
时间窗: Data will be assessed through study completion, on average one year
Assessed using Generalized Anxiety Disorder-7. A standard questionnaire composed of seven questions with scores ranging from 0 to 21. A score between 5 and 9 indicates mild anxiety, a score between 10 and 14 indicates moderate anxiety, and a score 15 or above indicates severe anxiety.
Health-related quality of life in bladder cancer patients and their caregivers: Short Form-12
时间窗: Data will be assessed through study completion, on average one year
Assessed using Short Form-12. A standard questionnaire with twelve questions, with a score from 0 to 100, where a zero indicates lowest level of health and 100 indicates highest level of health.
Financial Toxicity in bladder cancer patients and their caregivers
时间窗: Data will be assessed through study completion, on average one year
Assessed using single-item financial toxicity measure. The measure asks patients to indicate number that best describes their financial stress during pass week from a scale of 0 to 10 with 0 indicating no financial distress and 10 indicating extreme financial distress
次要结局
未报告次要终点
研究者
Elizabeth Wulff-Burchfield, MD
Principal Investigator
University of Kansas Medical Center