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临床试验/NCT02367950
NCT02367950Unknown不适用

Feasibility and Acceptability of Exercise as a Lifestyle Intervention in Endometrial Cancer Survivors.

Royal Cornwall Hospitals Trust2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
The number of invited participants that complete the tailored exercise programme (10 exercise sessions).

研究概览

简要总结

The purpose of the study is to evaluate the feasibility of introducing an exercise programme for endometrial cancer survivors.

详细描述

Objectives

  • To evaluate the feasibility of an exercise intervention for endometrial cancer survivors in terms of recruitment, adherence, response rates, and follow-up rate.
  • To evaluate the feasibility of the individual components of the exercise programme itself within the study population.
  • To evaluate if the outcomes measure used to evaluate quality of life outcomes such as psychological distress, fatigue and pain in endometrial cancer survivors are appropriate.
  • To evaluate if the outcome measures used to evaluate physical fitness are appropriate.
  • To evaluate the acceptability of an exercise intervention for endometrial cancer survivors to improve quality of life outcomes.

General research design Single-arm prospective feasibility study In addition we will conduct a qualitative evaluation with a purposively selected subgroup with maximum variation of our population.

Study population All women diagnosed at the Royal Cornwall Hospital with endometrial cancer who have completed surgical treatment.

Number of participants Every year approximately 90 women are diagnosed with endometrial cancer at the Royal Cornwall Hospital in Truro, of which approximately 80 women receive primary surgical treatment. We estimate that 50% to 60% will consent to participation in this study; we therefore anticipate that the sample size for a study duration of 12 months will be approximately 40 to 48 women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Confirmed diagnosis of endometrial cancer
  • Completion of surgical treatment for endometrial cancer
  • Age; 18 years or older.

排除标准

  • Women receiving treatment in the palliative setting
  • Women with recurrent diagnosis of endometrial cancer
  • Women with concurrent cancer
  • Women who are unable to give informed consent

结局指标

主要结局

The number of invited participants that complete the tailored exercise programme (10 exercise sessions).

时间窗: 18 months

The overall aim of this proposed feasibility study is to ensure that a larger trial can successfully be planned and delivered.

次要结局

  • Change from baseline in the Brief Fatigue Inventory outcome measures at 18 months and change from baseline in the Brief Pain Inventory outcome measures at 18 months.(18 months)
  • Change from baseline in the EORCT QLQ-C30 quality of life outcome measures at 18 months and change from baseline in the QLQ-EN24 quality of life outcome measures at 18 months.(18 months)

研究者

发起方
Royal Cornwall Hospitals Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khadra Galaal

Consultant Gynaecological Oncologist

Royal Cornwall Hospitals Trust

研究点 (2)

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