跳至主要内容
临床试验/NCT03148093
NCT03148093终止不适用

The CHOICE Registry: A Research Initiative Examining Clinical, Economic, and Humanistic Outcomes in the Management of Metastatic Colorectal Cancer

Taiho Oncology, Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
1
主要终点
Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)

研究概览

简要总结

The CHOICE Registry will describe real-world treatment patterns and physician and patient (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd line metastatic colorectal cancer.

详细描述

A prospective, non-interventional, observational, approach will be employed. All patient follow-up visits and other interactions will be established by the physician investigator: the CHOICE Registry will not impose a fixed schedule of follow-up visits. Data will be obtained in conjunction with actual follow-up visits to support treatment and various assessments of disease progression, patient quality of life and caregiver burden, and resource utilization. Patients will be followed for minimum of 15 months. All prescribed and administered medications, treatment adjustments and duration will be documented by the physician investigator treating the patient as per standard of care. The CHOICE Registry will not impose any change to the treatment regimen prescribed by physicians participating in the Registry. Adult males and females with metastatic colorectal cancer (having received first and second line treatment, and upon initiation of third line or later treatment) will be eligible to participate. Approximately 1000 patients will be enrolled by approximately 30 to 40 physician investigators representing both community and academic medical centers in the United States. Descriptive statistics will be employed to address the key research objectives of the CHOICE Registry, such as a description of patients receiving various second (and/or subsequent) lines of treatment in the management of metastatic colorectal cancer in real world clinical settings, and the associated clinical, economic, and humanistic (patient-reported) outcomes.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Diagnosis of metastatic CRC
  • Having completed first and second lines of treatment for metastatic CRC
  • Intending (at time of enrollment) to initiate a third (or subsequent) line of treatment
  • Ability to understand and read English or Spanish
  • Willing and able to sign an Informed Consent Form (ICF), or have a Legally Authorized Representative willing and able to consent on the patient's behalf

排除标准

  • Patient is unwilling or unable to participate in the Registry at the time of enrollment
  • The patient is currently participating in an investigational clinical trial
  • Patients not having mental capacity and or ability to participate in the Registry

结局指标

主要结局

Real-world treatment patterns as assessed by Work Productivity and Activity Impairment - Caregiver (WPAI)

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by Medication Satisfaction Questionnaire (MSQ)

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by EuroQoL EQ-5D-5L

时间窗: Approximately 15 months

Reasons for dose adjustments and/or discontinuation of treatments

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by Modified Caregiver Strain Index (MCSI)

时间窗: Approximately 15 months

Duration of therapy

时间窗: Approximately 15 months

Real-world treatment patterns as assessed by Healthcare resource utilization (physician visits, pharmacotherapy, hospitalizations, etc.)

时间窗: Approximately 15 months

次要结局

  • Treatment satisfaction in patients receiving various treatment regimens for mCRC per Medication Satisfaction Questionnaire (MSQ)(Approximately 15 months)
  • Healthcare Resource Utilization(Approximately 15 months)
  • Burden for caregivers providing support to patients enrolled in the registry per Modified Caregiver Strain Index (MCSI)(Approximately 15 months)
  • Quality-of-life of patients receiving specific treatment regimens for mCRC per FACT/NCCN-Colorectal Symptom Index-19 (FCSI-19)(Approximately 15 months)
  • Quality-of-life of patients receiving specific treatment regimens for mCRC per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Approximately 15 months)
  • Utility of patients receiving specific treatment regimens for mCRC per EuroQoL EQ-5D-5L(Approximately 15 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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