Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 408
- 试验地点
- 6
- 主要终点
- Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
研究概览
简要总结
Bladder cancer is the most common urinary tract cancer and the 6th most common cancer in the US. Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Study 2 (CISTO2) has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO2 is to conduct a large prospective study that directly compares the impact of bladder sparing therapies versus bladder removal in recurrent high-grade NMIBC patients on financial toxicity, clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
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
- •Adult 18 years of age or older; and
- •Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
- •Pathology documentation from any hospital/clinic/medical center
- •More than 50% urothelial carcinoma component in the specimen; and
- •History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
- •In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
排除标准
- •Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
- •Previous history of cystectomy or radiation therapy for bladder cancer;
- •Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
- •Untreated or current urinary tract urothelial carcinoma outside of the bladder (e.g. ureters, renal pelvis, penile urethra for males, urethra for females). Urinary tract cancer outside of the bladder treated more than 2 years ago is not an exclusion;
- •Incarcerated in a detention facility or in police custody at baseline/screening (patients wearing a monitoring device can be enrolled);
- •Contraindication to radical cystectomy (e.g., ASA of 4, patient not considered a radical cystectomy candidate due to comorbidity);
- •Contraindication to BST (i.e., intolerant of all intravesical and intravenous medical therapies);
- •Unable to provide written informed consent in English;
- •Unable to be contacted for research surveys;
- •Planning to participate in a blinded interventional clinical trial for NMIBC such that details about treatment or therapy received will be unavailable for data collection.
研究组 & 干预措施
Caregivers of patients who have selected radical cystectomy
Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
Caregivers of patients who have selected bladder-sparing therapy
Caregivers of patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
Patients who have selected radical cystectomy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
Patients who have selected bladder-sparing therapy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
结局指标
主要结局
Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)
时间窗: 12 months after enrollment
The primary outcome of patient-reported financial toxicity is measured by the COST measure. The questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating less financial toxicity. Item nonresponse is accounted for by summing the items answered, multiplying by the total number of items in the scale, and then dividing by the number of items that were actually answered.
次要结局
- Patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L(12 months after enrollment)
- Caregiver-reported generic quality of life as measured by the EuroQoL EQ-5D-5L(12 months after enrollment)
- Patient-reported financial toxicity as measured by the COmprehensive Score for financial Toxicity (COST)(24 months after enrollment)
- Caregiver self-reported financial distress as measured by the modified Comprehensive Score for Financial Toxicity (COST)(12 months after enrollment)
- Patient self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale(12 months after enrollment)
- Caregiver self-reported financial well-being as measured by the Consumer Financial Protection Bureau (CFPB) Financial Well-Being Scale(12 months after enrollment)
- Caregiver self-reported quality of life as measured by the CareGiver Oncology Quality of Life questionnaire (CarGOQol)(12 months after enrollment)
- Patient-reported quality of life as measured by the Physical Function scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)(12 months after enrollment)
- Patient self-reported urinary health as measured by the Bladder Cancer Index urinary summary score(12 months after enrollment)
- Patient-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a(12 months after enrollment)
- Patient-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a(12 months after enrollment)
- Caregiver-reported anxiety as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a(12 months after enrollment)
- Caregiver-reported depression as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a(12 months after enrollment)
- Patient progression-free survival(12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment)
- Patient bladder cancer-specific survival(12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment)
研究者
John Gore
Vice Chair of Research, Professor, School of Medicine: Urology
University of Washington