跳至主要内容
临床试验/NCT01108315
NCT01108315已完成1 期

Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

BrightOutcome4 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
BrightOutcome
入组人数
138
试验地点
4
主要终点
Usability and effectiveness of the prototype

研究概览

简要总结

Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.

When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.

PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, breast oncology patient
  • Breast cancer diagnosis
  • Expected chemotherapy regimen of at least 3-4 months
  • Sufficient cognitive ability and psychological stability in the opinion of treating physician
  • Fluent in spoken and written English
  • 18 years of age or older
  • Outpatient
  • Life expectancy > 6 months as estimated by treating physician
  • Informed of the investigational nature of this study and provided informed consent.
  • Has access to either a phone or the internet

排除标准

  • Is not female, nor a breast oncology patient
  • Does not have breast cancer diagnosis
  • Expected chemotherapy regimen is less than 3-4 months
  • Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
  • Is not fluent in spoken and written English
  • Is younger than 18 years of age
  • Inpatient
  • Life expectancy < 6 months as estimated by treating physician
  • Is not informed of the investigational nature of this study and does not provide informed consent.
  • Does not have access to either a phone or internet.

结局指标

主要结局

Usability and effectiveness of the prototype

时间窗: 6 months

Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication

次要结局

未报告次要终点

研究者

发起方
BrightOutcome
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Niina Haas

Project Director

BrightOutcome

研究点 (4)

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