A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient Reported Symptom Severity and Interference
研究概览
简要总结
The goal of this clinical research study is to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. Researchers will study the possible reason for these symptoms by drawing blood samples and comparing the test results to the symptoms you experience. The study will also use a special telephone system for measuring the symptoms of participants during and after therapy. Your level of physical activity will also be studied using a pedometer and study diary.
详细描述
Researchers want to try to improve patient care for advanced pancreatic cancer by looking at how some symptoms create a great burden on daily life. They also want to find out which "markers" in the blood. Biomarkers are substances found in the blood, such as cytokines, certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom burden" during therapy.
Researchers would also like to collect data about your physical function as part of this study. If you agree to wear a pedometer, you will wear the pedometer every day for a month during your waking hours. The pedometer used in the study is a small box that weighs less than an ounce and is smaller than a deck of playing cards. It is used to measure the number of steps you take during the day. Researchers will help you set the pedometer and show you how to use it. You will also keep a diary to record your use of the pedometer during this month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks and 4 weeks to collect the data.
If you agree to take part in this study, you will have the following 4 types of study procedures performed:
Questionnaire:
Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be asked to complete a questionnaire during a visit to the clinic. The questionnaire will measures physical and emotional symptoms. It should take about 5 minutes to finish. During this visit, the research staff will also teach you how to use the telephone system for measuring symptoms. You will tell the research staff the most convenient times for the telephone calls each week and the system will be set up to call you at that time.
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 must have histologically or cytologically confirmed cancer of the pancreas.
- •Patients must have inoperable locally advanced or metastatic disease.
- •Patients could be on treatment, or being planned for chemotherapy treatment.
- •Age 18 years of age or older
- •ECOG performance status 0-3
- •Ability to give consent in either English or Spanish
排除标准
- •Any condition (including unwillingness) that would impair the patient's ability to utilize the IVR system
- •Any recent surgical procedures (within 14 days, excluding biopsy, port-a-cath or picc line placement)
结局指标
主要结局
Patient Reported Symptom Severity and Interference
时间窗: Weekly for 8 cycles of chemotherapy, followed by twice a month for 14 months
次要结局
未报告次要终点