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临床试验/NCT00804817
NCT00804817已完成不适用

Somatic-psychosocial Multidisciplinary Care Concept for Oncologic Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT): a Prospective Non-randomized Clinical Trial

Martin-Luther-Universität Halle-Wittenberg2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2007年12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
84
试验地点
2
主要终点
Health Related Quality of Life (HRQoL)

研究概览

简要总结

This study will test the SCION (Self care improvement through oncology nursing)-HSCT program a multi-modular, somatic-psycho-social care intervention to improve self management in oncologic patients undergoing HSCT. The study will determine if the self management skills of the patients to enhance:

  • physical activity,
  • prevention of oral mucositis and
  • mal nutrition during the period of hospitalization.

It is hypothesized that patients who receive the multi-modular somatic-psycho-social care intervention will have better health related quality of life (HRQoL).

详细描述

According to Precede Model of health behavior from Green - modified by our research group - patients self management skills are affected by the patients' knowledge, activities and attitude to self management.

Therefore, we propose a prospective non-randomized clinical trial that will test the effectiveness of SCION-HSCT program against care as usual on perceived HRQoL of the patient and the adherence to care program.

Oncology patients with HSCT will be recruited by the nurses of the participating wards under the guidance of a research nurse. They will be included in the trial if they will meet the inclusion criteria and signed informed consent (the full inclusion criteria see below).

Groups will be treated consecutively. The first group will receive care as usual (Control). After finishing the control period, i.e. after 42 Patients will have completed the trial. The the newly assigned patients will be treated according to SCION-HSCT program a multi-modular somatic-psycho-social care intervention (Intervention).

The intervention will be conducted by specially trained ward nurses in cooperation with the research nurse. It includes components of knowledge, skills training, and coaching to improve patients adherence to self management strategies for physical activity, prevention of oral mucositis and mal nutrition prevention. The HRQoL, adherence and symptom level of the patients will be observed up to 100 days post HSCT. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

研究设计

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

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hematologic Patients (> 14 years of age)
  • Hematological stem cell transplantation (HSCT) allogenic or autologous
  • Informed consent

排除标准

  • Unable to read, write, and understand German

结局指标

主要结局

Health Related Quality of Life (HRQoL)

时间窗: day before discharge from hospital

次要结局

  • Physical Fitness (Step-Test)(day before discharge from hospital)
  • Fatigue (Fatigue Symptom Inventory - D (German))(day before discharge from hospital)
  • Physical Resources (German Conservation of Resources Evaluation (GCOR))(day before discharge from hospital)
  • Symptom experience (Common Terminology Criteria for adverse events - CTCAE v. 3.0)(day before discharge from hospital)

研究者

申办方类型
Other

研究点 (2)

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