Acupressure for Cancer-Related Fatigue

Not Applicable

• Conditions: Breast Cancer
• Interventions: Behavioral: acupressure intervention; Behavioral: usual care

• Registration Number: NCT03091647
• Lead Sponsor: Georgetown University

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 Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

• have hypothyroidism and anemia
• being using acupuncture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupressure intervention	acupressure intervention	Practice acupressure at home and complete daily logs
usual care	usual care	Receive usual care and complete daily logs

Primary Outcome Measures

Name	Time	Method
Cancer-related fatigue (proximal outcome)	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 Outcome Measures

Name	Time	Method
Physical functioning (distal outcomes)	8 weeks post-intervention	The secondary outcomes will be measure by 8-item PROMIS (e.g., ability in carrying grocery, kneeling, climbing stairs).
Sleep disturbance	8 weeks post-intervention	The secondary outcomes will be measure by 6-item PROMIS (e.g., sleep not steady, unsatisfied, hard to fall asleep).
Depression	8 weeks post-intervention	The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
Pain interference	8 weeks post-intervention	The secondary outcomes will be measure by 6-item PROMIS (e.g., affecting ability to focus, interact with others, run errands).
Anxiety	8 weeks post-intervention	The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States