Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Georgetown University
- Enrollment
- 124
- Locations
- 2
- Primary Endpoint
- Cancer-related fatigue (proximal outcome)
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 74 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •have hypothyroidism and anemia
- •being using acupuncture
Outcomes
Primary Outcomes
Cancer-related fatigue (proximal outcome)
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Judy Wang
Associate Professor
Georgetown University