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临床试验/NCT04269967
NCT04269967招募中不适用

A Pilot Feasibility Study of a Tele-rehabilitation System Among Women Who Undergo a Unilateral Mastectomy for Breast Cancer

National University of Singapore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Arm circumference

研究概览

简要总结

Breast cancer is the leading cancer affecting women in Singapore. Breast cancer survivors commonly experience declined physical function and quality of life, due to their upper limb morbidity and wound issues post-surgery. Rehabilitation therapy can address the aforementioned issues that the survivors may experience during their recovery. No therapy however, can be effective if patients do not utilize them. Home-based telehealth (e.g., tele-rehabilitation) self-managed by patients and guided by healthcare professionals can potentially improve the service use and recovery. This study aims to understand the lived experience of post-mastectomy tele-rehabilitation and recovery process among female patients who undergo a unilateral mastectomy for breast cancer.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 21 years and over
  • Underwent a recent unilateral breast surgery (wide excision or simple mastectomy) with lymph nodes removed
  • Speak and write English or Mandarin;
  • No psychiatric history or chronic psychiatric condition as assessed by referring clinician

排除标准

  • Having breast reconstruction
  • Having legal blindness or severe visual impairment
  • Having life expectancy of less than three months (12- weeks)
  • Having previous upper limb injury or conditions that limit passive ranges of shoulder flexion (<150°), elbow extension/flexion (0/145°)

结局指标

主要结局

Arm circumference

时间窗: Pre rehabilitation (week 0) and post-rehabilitation (week 12)

Arm circumference will be measured in cm

The experience of rehabilitation (i.e., drain care, exercise and massage)

时间窗: 12 weeks from the baseline assessment

We will interview our participants about their experience of going through a rehabilitation process. This is qualitative data.

Shoulder range of motion

时间窗: Pre rehabilitation (week 0) and post-rehabilitation (week 12)

Shoulder ranger of motion will be measured in degree.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miho Asano

Assistant Professor

National University of Singapore

研究点 (1)

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