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临床试验/NCT02828462
NCT02828462Unknown不适用

Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics

Gustave Roussy, Cancer Campus, Grand Paris1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年10月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Relative dose intensity

研究概览

简要总结

The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients (male or female) aged > 18 years
  • Life expectancy > 6 months
  • Patients with tumour or hematological malignancy being treated at Gustave Roussy
  • Patients with oral therapy (cytotoxic or targeted therapies)
  • Patients starting therapy
  • Patients living in France
  • Patients affiliated to a social security system or equivalent
  • OMS score from 0 to 2 at the time of inclusion
  • Signed inform consent
  • Patients able to follow protocol

排除标准

  • Patients being treated with hormonotherapy only
  • Patients enrolled in a clinical trial ongoing treatment with an experimental compound except in the case where the sponsor agrees that the CAPRI protocol is not intefering with the trial
  • Not French speaking patients
  • Patients deprived of liberty
  • Patients with no internet access or telephone line

结局指标

主要结局

Relative dose intensity

时间窗: Assessed every 30 days from randomization up to 6 months

RDI will be calculated as follow "delivered dose intensity/dose intensity of the standard tumor regimen"

次要结局

  • Toxicity(Assessed every 30 days from randomization up to 6 months)
  • Compliance(Assessed every 30 days from randomization up to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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