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临床试验/NCT01272648
NCT01272648已完成2 期

Rehabilitation and Coping of Effects After Curative Radiotherapy for Prostate

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
161
试验地点
1
主要终点
HRQOL urinary irritative score

研究概览

简要总结

This project will test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project examines if a focused interdisciplinary intervention has influence of the patients generic and specified quality of life after curative radiotherapy due to prostate cancer.

The intervention contains nursing consultation with information about late side effects, an individual plan and counselling in toilet habits, smoking cessation, weight control and psychological problems after treatment. Furthermore the patients are having physiotherapy with pelvic floor examinations. The nurse can refer to other collaborators.

详细描述

More cancer patients are now being cured or living a long time with the disease. Prostate cancer (PCa) is one of the cancer diseases, where the treatment can give some late side effects and cause reduced life quality.

This project will as a part of a ph.d. study, test and evaluate a rehabilitation programme, which will empower the mens health and give them resources to face at new everyday life.

The project is consisted of a randomised controlled test of the intervention and qualitative evaluation.

More and more Danish men are diagnosed with PC, the incidence increased with 34 percent from 2005-2007. This is caused partly due to a change in the age in the society and due to earlier diagnostics. PCa is now the most known cancer occurring in men in Denmark.

If the disease has not yet been metastasized, it is possible to use radiotherapy often in combination with anti hormones. It is possible to cure the patient, íf his disease is discovered in time, but there are some late side effects bond to the treatment, and they have influence of the patients quality of life. These are: impotence, incontinence, problem with the bowels, anxiety and depression.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Patients with localized og locally advanced prostate cancer treated with curative intended radiotherapy at Department of Oncology Odense University Hospital in the period of inclusion

排除标准

  • •Patients younger than 18
  • •Patients who cannot understand/read or speak danish

研究组 & 干预措施

Rehabilitation

Active Comparator

note intervention

干预措施: RePCa A (Behavioral)

Control

Placebo Comparator

same radiotherapy but no rehabilitation

干预措施: RePCa A (Behavioral)

结局指标

主要结局

HRQOL urinary irritative score

时间窗: 12 month

The expanded prostate cancer Index Composite (EPIC)irritative score

次要结局

  • EMG measurement of pelvic floor muscles(12 month)

研究者

申办方类型
Other

研究点 (1)

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