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临床试验/NCT01588262
NCT01588262已完成不适用

Early Rehabilitation of Cancer Patients

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011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
300
试验地点
2
主要终点
Change in psychosocial status

研究概览

简要总结

A life threatening disease such as cancer may lead to post traumatic stress disorder, and even when reporting low levels of side-effects from cancer disease and treatment, 80% report high levels of stress symptoms. The purpose of the present randomised controlled trial is to examine the psychosocial effects of a stress management intervention based on cognitive behaviour therapy and with focus on increased physical activity in patients with various cancer diagnoses using a stepped-care approach. When using a stepped-care approach it is possible to study the level and intensity of stress management intervention required to achieve increased well-being. A cost-utility analysis will also be performed. 300 adult patients with a recent diagnosis of breast-, colorectal- prostate, testicular cancer or lymphoma and scheduled for adjuvant and/or curative oncologic treatment at Haukeland University Hospital, will be consecutively included in the prospective intervention study. The patients will be randomized to intervention or control. In step 1, all patients in the intervention group (I-a) will receive 2 counselling sessions. Patients who report clinically significant levels of stress, such as intrusive thoughts/avoidance behaviour (measured by Impact of Event Scale) and/or worry and depressions (measured by Hospital and Depression Scale) will be included in Step 2 (I-b) and include another 4-7 counselling sessions. There will also be a focus on motivating to increase physical activity level. Both the intervention (I) and control group (C) are allowed to take part in the common rehabilitation program with patient education and physical training. Data will be collected with self-reported standardized questionnaires. Objectively measures of physical activity level, sleep and daily energy expenditure are recorded with SenseWear™ Pro3 Armband. Measure point is at inclusion and than after 6 week, 4, 8, 12 and 24 month.

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 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed with breast cancer,
  • colorectal cancer,
  • lymphoma,
  • prostate cancer or testicle cancer and scheduled for adjuvant and/or curative treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy at the Department of Oncology and Medical physics, Haukeland University Hospital, (Dept. of Oncology) Bergen,
  • residence in Rogaland, Hordaland and Sogn and fjordane county council,
  • initial treatment for cancer

排除标准

  • An ongoing psychiatric condition,
  • language deficiencies in Norwegian,
  • surgery for prostate cancer (only applies for prostate cancer) patients),
  • men with breast cancer,
  • live in nursing homes,
  • previous cancer,
  • treated for cancer earlier,
  • already implemented oncological treatment,
  • not self-reliant

结局指标

主要结局

Change in psychosocial status

时间窗: from baseline to 24 month

次要结局

  • Cost effectiveness of the stress-management intervention.(24 month)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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