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临床试验/NCT00710658
NCT00710658已完成不适用

A Randomized Clincial Trial to Evaluate the Effects of an Internett-based Support System for Cancer Patients on Symptom Distress, Depression, and Quality of Life.

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2006年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
325
试验地点
2
主要终点
Symptom distress

研究概览

简要总结

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

This randomized clinical trial:

  1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze:
  2. Relationships between primary and secondary outcomes;
  3. How patients' symptom distress varies over time;
  4. Patients' preferences for participation in decision making about symptom management
  5. How patients use WebChoice, such as frequency of use, duration, most used components;
  6. How patients' experience WebChoice's usefulness and ease of use;
  7. Patterns and content of patients' communication with the cancer nurse and other patients.

325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

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
None

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

  • Above 18 years
  • Starting or currently undergoing treatment for breast or prostate cancer
  • Internet access at home

排除标准

  • Patients who had received radiation on the brain as this may have affected their abilities to reliably report their symptoms.

结局指标

主要结局

Symptom distress

时间窗: prospective, one year, repeated measures

Quality of life

时间窗: prospective, one year, repeated measures

Depression

时间窗: prospective, one year, repeated measures

次要结局

  • Self-efficacy(prospective, one year, repeated measures)
  • Social support(prospective, one year, repeated measures)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cornelia Ruland

Professor

Oslo University Hospital

研究点 (2)

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