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临床试验/NCT02716168
NCT02716168已完成不适用

Partnership-Project - Reinforcing Partnership Between Cancer Patient, General Practitioner and Oncologist During Chemotherapy - a Randomized Controlled Trial

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
281
试验地点
2
主要终点
Shared Care questionnaire

研究概览

简要总结

Background International guidelines underline the importance of strengthening the coordination and continuity of cancer care. The different roles of general practitioners and oncologists with regard to treatment, follow-up and rehabilitation during and after cancer treatment are often obscure to cancer patients. Parallel courses of healthcare are often taking place instead of coordinated care characterized by continuity and partnership between care providers. Patients may feel uncertain about the health professionals' skills and area of responsibility. Healthcare seeking and support during and after cancer treatment may, therefore, be inappropriate, leaving patients feeling insecure and lost between care providers.The study aims to design and evaluate a new way of communication and shared decision-making that brings the patient, the oncologist and general practitioner together in a shared video-consultation in the early phase of chemotherapeutic treatment. The effect of the intervention in addition to usual care will be tested in a randomized controlled trial at Vejle Hospital in the Region of Southern Denmark. Based on sample size calculation, investigators intent to include 300 patients at the Department of Oncology and their general practitioners. Results and process outcomes will be evaluated qualitatively and quantitatively, questionnaires to patients, general practitioners and oncologists, and data from registers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

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

  • Newly referred cancer patient scheduled for chemotherapy at the Department for Oncology, Vejle Hospital, Region of Southern Denmark
  • Aged 18 years and over
  • Able to speak and read Danish
  • Mentally able to cooperate
  • Listed with a general practitioner (98 % of the danish population)
  • Written and verbal informed consent given

排除标准

  • 未提供

结局指标

主要结局

Shared Care questionnaire

时间窗: 7 month after inclusion

Patient reported outcome measure. Cancer patients assessment of their cancer trajectory and their assessment of the cooperation between their General Practitioner and the oncologist specialist.

次要结局

  • European Organisation for Research and Treatment of Cancer - Quality of Life questionnaire - Core 30 (EORTC QLQ C30)(4 and 7 month after inclusion)
  • European Organisation for Research and Treatment of Cancer - Quality of Life- information questionnaire (EORTC QLQ INFO25)(4 and 7 month after inclusion)
  • Illness Intrusiveness Rating Scale (IIRS)(4 and 7 month after inclusion)
  • Generalised Anxiety Disorder Assessment (GAD-7)(4 and 7 month after inclusion)
  • Patient Health Questionnaire (PHQ-9)(4 and 7 month after inclusion)
  • Oncologist assessment of a video consultation between the patient, General practitioner and oncologist.(Directly after the video consultation intervention)
  • General practitioners assessment of a video consultation between the patient, General practitioner and oncologist.(Directly after the video consultation intervention)
  • Patients assessment of a video consultation between the patient, General practitioner and oncologist.(Directly after the video consultation intervention)
  • General Practitioner cancer trajectory assessment(4 month after the inclusion of the patient.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theis Trabjerg

MD, PhD fellow

University of Southern Denmark

研究点 (2)

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