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临床试验/NCT03091647
NCT03091647Unknown不适用

Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors

Georgetown University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
124
试验地点
1
主要终点
Cancer-related fatigue (proximal outcome)

研究概览

简要总结

This study develops and pilot tests the efficacy of a home-based, self-administered acupressure intervention in improving cancer-related fatigue (proximal outcome), and physical functioning and other quality of life outcomes (distal outcomes) of Chinese immigrant breast cancer survivors (versus usual care control group).

详细描述

We will enroll 124 foreign-born, Chinese-speaking women from Southern California and Maryland areas with moderate to severe levels of fatigue, diagnosed with stage 0-IV breast cancer, aged 21-74, and 1-5 years post-primary treatment. Using an adaptive treatment strategy design, participants will be randomized to either the acupressure intervention or control groups. The acupressure group will learn how to press three chief energy acupoints on each side of the body through de novo 11-minute Chinese-language video and practice acupressure every day (one minute per acupoint; a total of 6 minutes per day) for an 8-week intervention period. Participants will be telephone interviewed twice: at baseline and 8-weeks post-intervention follow-up.

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
21 Years 至 74 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •be between ages 21 to 74
  • •be first-generation immigrants
  • •speak Chinese (Mandarin and/or Cantonese)
  • •be diagnosed with breast cancer at stage 0, I, II III or IV
  • •have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment
  • •have not had recurrence
  • •have moderate to severe levels of fatigue.

排除标准

  • •have hypothyroidism and anemia
  • •being using acupuncture

研究组 & 干预措施

acupressure intervention

Experimental

Practice acupressure at home and complete daily logs

干预措施: acupressure intervention (Behavioral)

usual care

Placebo Comparator

Receive usual care and complete daily logs

干预措施: usual care (Behavioral)

结局指标

主要结局

Cancer-related fatigue (proximal outcome)

时间窗: 8 weeks post-intervention

The primary outcome will be measured by 6-item PROMIS (Patient-Reported Outcomes Measurement Information System) (e.g., felt tired, exhausted, limited at work).

次要结局

  • Physical functioning (distal outcomes)(8 weeks post-intervention)
  • Sleep disturbance(8 weeks post-intervention)
  • Depression(8 weeks post-intervention)
  • Pain interference(8 weeks post-intervention)
  • Anxiety(8 weeks post-intervention)

研究者

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

Judy Wang

Associate Professor

Georgetown University

研究点 (1)

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