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临床试验/NCT01651832
NCT01651832已完成不适用

Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial

Martin-Luther-Universität Halle-Wittenberg18 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2012年7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
261
试验地点
18
主要终点
proportion of eligible patients undergoing adjuvant chemo therapy

研究概览

简要总结

Aim of the study is to increase the proportion of indicated patients with colorectal cancer undergoing adjuvant chemotherapy following surgical resection through an optimized symptom management and logistical support.

详细描述

Patients with colorectal cancer in Germany today are exposed to several Problems related to care continuity and access to health care professionals. In order to increase the utilization of adjuvant therapies, patients in the intervention group are offered an additional nursing intervention in the period between discharge after inpatient treatment and the beginning of adjuvant therapy. This includes a telephone follow-up conducted according to guidelines serving to disclose patients' current supportive needs in order to determine potential intervention approaches as early as possible. Hence, the intervention aims to motivate patients not to discontinue the treatment. An early detection of therapy-related physical and psychological impairments aims at optimizing treatment management.

Patients in the intervention group therefore are visited by nursing staff specialized in cancer care (Supportive Cancer Care Networkers, SCAN) during their in-patient stay and are informed about the intervention. An assignment for the SCAN is to support patients in getting access to health care services (e.g. specialists). Patients are given certain information, as for example contact to specialists, voluntary services and the next steps and appointments of the treatment plan are discussed. Within a consultation at the day before hospital discharge, the SCAN takes up the contact information and appoints weekly telephone consultations for the time up to the adjuvant therapy. The SCAN hands out information materials and explains the study documents, as for example patient-held records (PHR) in order to improve therapy compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • colorectal carcinoma (ICD-10: C18, C19, C20)
  • indication for adjuvant chemo therapy following S3-Guideline on colorectal Cancer or physician-directed
  • living in Saxony-Anhalt
  • ECOG-Performance Status <3
  • prospective further life expectancy of more than three months

排除标准

  • unable to read or understand German properly
  • any contra-indication for adjuvant therapy as described in the S3-Guideline such as inadequate liver, bone marrow, and kidney function or coronary heart disease (NYHA III-IV).

结局指标

主要结局

proportion of eligible patients undergoing adjuvant chemo therapy

时间窗: 8 weeks after hospital discharge/ chrirurgical resection

次要结局

  • Distress(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
  • symptom burden(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
  • Quality of inpatient care(at Baseline)
  • disease-free survival(8 month after hospital discharge/ chrirurgical resection)
  • Health-related Quality of Life(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
  • supportive care needs(8 weeks & 8 month after hospital discharge/ chrirurgical resection)

研究者

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

Alexander Bauer

Scientific Research Fellow

Martin-Luther-Universität Halle-Wittenberg

研究点 (18)

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