此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Collection of Patient-Reported Symptoms and Performance Status Via the Internet

2017年6月26日 更新者：Alliance for Clinical Trials in Oncology
This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers.

II. To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events (CTCAE) symptom severity scoring, and to measure whether their scores converge when clinicians are exposed to patient self-reports.

OUTLINE:

Patients are registered into the Symptom Tracking and Reporting (STAR) database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4* of chemotherapy. Clinicians complete feedback survey at study completion.

研究类型

介入性

注册 (实际的)

325

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Castro Valley、California、美国、94546
        • East Bay Radiation Oncology Center
      • Castro Valley、California、美国、94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont、California、美国、94538
        • Valley Medical Oncology
      • Martinez、California、美国、94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View、California、美国、94040
        • El Camino Hospital Cancer Center
      • Oakland、California、美国、94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland、California、美国、94602
        • Highland General Hospital
      • Oakland、California、美国、94609
        • Larry G Strieff MD Medical Corporation
      • Oakland、California、美国、94609
        • CCOP - Bay Area Tumor Institute
      • Oakland、California、美国、94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland、California、美国、94609
        • Tom K Lee, Incorporated
      • San Francisco、California、美国、94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • San Pablo、California、美国、94806
        • Doctors Medical Center - San Pablo Campus
    • Delaware
      • Lewes、Delaware、美国、19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark、Delaware、美国、19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Orlando、Florida、美国、32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
    • Illinois
      • Chicago、Illinois、美国、60637-1470
        • University of Chicago Cancer Research Center
      • Chicago、Illinois、美国、60640
        • Louis A. Weiss Memorial Hospital
      • La Grange、Illinois、美国、60525
        • La Grange Memorial Hospital
      • Rockford、Illinois、美国、61108
        • Center for Cancer Care at OSF Saint Anthony Medical Center
    • Indiana
      • Elkhart、Indiana、美国、46515
        • Elkhart General Hospital
      • Elkhart、Indiana、美国、46514-2098
        • Elkhart Clinic, LLC
      • Elkhart、Indiana、美国、46514
        • Michiana Hematology-Oncology, PC - Elkhart
      • Kokomo、Indiana、美国、46904
        • Howard Community Hospital
      • La Porte、Indiana、美国、46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka、Indiana、美国、46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka、Indiana、美国、46545-1470
        • Saint Joseph Regional Medical Center
      • Plymouth、Indiana、美国、46563
        • Michiana Hematology Oncology PC - Plymouth
      • South Bend、Indiana、美国、46601
        • Memorial Hospital of South Bend
      • South Bend、Indiana、美国、46601
        • CCOP - Northern Indiana CR Consortium
      • Westville、Indiana、美国、46391
        • Michiana Hematology Oncology PC - La Porte
    • Iowa
      • Iowa City、Iowa、美国、52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
      • Iowa City、Iowa、美国、52246
        • Veterans Affairs Medical Center - Iowa City
    • Kansas
      • Overland Park、Kansas、美国、66209
        • Menorah Medical Center
      • Overland Park、Kansas、美国、66213
        • Saint Luke's Hospital - South
      • Prairie Village、Kansas、美国、66208
        • CCOP - Kansas City
    • Maine
      • Bangor、Maine、美国、04401
        • CancerCare of Maine at Eastern Maine Medical Center
    • Maryland
      • Elkton、Maryland、美国、21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02115
        • Dana-Farber/Brigham and Women's Cancer Center
      • Boston、Massachusetts、美国、02115
        • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    • Michigan
      • Niles、Michigan、美国、49120
        • Michiana Hematology Oncology PC - Niles
      • Saint Joseph、Michigan、美国、49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph、Michigan、美国、49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Missouri
      • Cape Girardeau、Missouri、美国、63703
        • Southeast Cancer Center
      • Jefferson City、Missouri、美国、65109
        • Goldschmidt Cancer Center
      • Kansas City、Missouri、美国、64116
        • North Kansas City Hospital
      • Kansas City、Missouri、美国、64132
        • Research Medical Center
      • Kansas City、Missouri、美国、64108
        • Truman Medical Center - Hospital Hill
      • Kansas City、Missouri、美国、64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City、Missouri、美国、64114
        • St. Joseph Medical Center
      • Kansas City、Missouri、美国、64116
        • Parvin Radiation Oncology
      • Lee's Summit、Missouri、美国、64086
        • Saint Luke's East - Lee's Summit
      • Liberty、Missouri、美国、64068
        • Liberty Hospital
      • Saint Joseph、Missouri、美国、64506
        • Heartland Regional Medical Center
      • Saint Louis、Missouri、美国、63131
        • Missouri Baptist Cancer Center
      • Saint Louis、Missouri、美国、63141
        • Comprehensive Cancer Care, PC
    • Nevada
      • Las Vegas、Nevada、美国、89102
        • University Medical Center of Southern Nevada
      • Las Vegas、Nevada、美国、89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord、New Hampshire、美国、03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett、New Hampshire、美国、03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia、New Hampshire、美国、03246
        • Lakes Region General Hospital
      • Lebanon、New Hampshire、美国、03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester、New Hampshire、美国、03102
        • Norris Cotton Cancer Center at Catholic Medical Center
    • New Jersey
      • Voorhees、New Jersey、美国、08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • East Syracuse、New York、美国、13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Elmhurst、New York、美国、11373
        • Elmhurst Hospital Center
      • Jamaica、New York、美国、11432
        • Queens Cancer Center of Queens Hospital
      • Lake Success、New York、美国、11042
        • Monter Cancer Center of the North Shore-LIJ Health System
      • Manhasset、New York、美国、11030
        • CCOP - North Shore University Hospital
      • Manhasset、New York、美国、11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New Hyde Park、New York、美国、11040
        • Long Island Jewish Medical Center
      • New York、New York、美国、10065
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse、New York、美国、13210
        • Veterans Affairs Medical Center - Syracuse
    • North Carolina
      • Asheville、North Carolina、美国、28801
        • Mission Hospitals - Memorial Campus
      • Chapel Hill、North Carolina、美国、27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Durham、North Carolina、美国、27710
        • Duke Comprehensive Cancer Center
      • Goldsboro、North Carolina、美国、27534
        • Wayne Memorial Hospital, Incorporated
      • Pinehurst、North Carolina、美国、28374
        • FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
      • Statesville、North Carolina、美国、28677
        • Iredell Memorial Hospital
      • Winston-Salem、North Carolina、美国、27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • Miriam Hospital
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Easley、South Carolina、美国、29640
        • Cancer Centers of the Carolinas - Easley
      • Greenville、South Carolina、美国、29615
        • CCOP - Greenville
      • Greenville、South Carolina、美国、29605
        • Greenville Hospital Cancer Center
      • Greenville、South Carolina、美国、29605
        • Cancer Centers of the Carolinas - Faris Road
      • Greenville、South Carolina、美国、29605
        • Cancer Centers of the Carolinas - Grove Commons
      • Greenville、South Carolina、美国、29601
        • Bon Secours St. Francis Health System
      • Greenwood、South Carolina、美国、29646
        • Self Regional Cancer Center at Self Regional Medical Center
      • Greer、South Carolina、美国、29650
        • Cancer Centers of the Carolinas - Greer Medical Oncology
      • Seneca、South Carolina、美国、29672
        • Cancer Centers of the Carolinas - Seneca
      • Spartanburg、South Carolina、美国、29307
        • Cancer Centers of the Carolinas - Spartanburg
    • Vermont
      • Berlin Corners、Vermont、美国、05602
        • Mountainview Medical
      • Burlington、Vermont、美国、05401
        • Fletcher Allen Health Care - University Health Center Campus

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405

PATIENT CHARACTERISTICS:

  • Able to read and comprehend English language text
  • Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：(Internet-based STAR database)

Patients are registered into the STAR database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4* of chemotherapy. Clinicians complete feedback survey at study completion.

NOTE: *All time points are based on scheduled therapy with clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-70604, CALGB-80405, or CALGB-40503.
其他：问卷管理
辅助研究
其他：internet-based intervention
Use the STAR database system
其他：assessment of therapy complications
Use the STAR database system

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Willingness of approached patients to participate in this study this study
大体时间：Up to 6 years
Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
大体时间：Up to 16 weeks
Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
大体时间：Up to 15 weeks
Up to 15 weeks

次要结果测量

结果测量
大体时间
Patient-reported CTCAE symptoms using symptom severity data
大体时间：At baseline (day 22)
At baseline (day 22)
Clinician-reported CTCAE symptoms using symptom severity data clinician reporting at day 43 (when patients report before clinicians; clinicians view those reports) vs at day 22 (patients report symptoms after the clinical encounter)
大体时间：At baseline (day 22)
At baseline (day 22)
Mean severity scores for patient reporting at day 43
大体时间：Up to day 43
Up to day 43

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Ethan Basch, MD、Memorial Sloan Kettering Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2006年12月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2017年6月1日

研究注册日期

首次提交

2006年12月27日

首先提交符合 QC 标准的

2006年12月27日

首次发布 (估计)

2006年12月28日

研究记录更新

最后更新发布 (实际的)

2017年6月27日

上次提交的符合 QC 标准的更新

2017年6月26日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CALGB-70501
  • UG1CA189823 (美国 NIH 拨款/合同)
  • U10CA037447 (美国 NIH 拨款/合同)
  • CDR0000521898 (注册表标识符：NCI Physician Data Query)
  • NCI-2009-00489 (注册表标识符：NCI Clinical Trial Reporting Program)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅