Acupressure for Cancer-Related Fatigue

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: acupressure intervention
* Behavioral: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupressure intervention<br>Practice acupressure at home and complete daily logs | Behavioral: acupressure intervention<br>* Women in the acupressure intervention group will learn how to press three chief energy acupoints on each side of the body through an 11-minute Chinese-language video and press three acupoints (1 minute per acupoint) on both sides of the body every day for a total of 6 minutes per day for an 8-week intervention period and record their practice on daily logs. Women will be asked to return the logs every week by email or self-addressed envelopes.<br>|
| Placebo Comparator: usual care<br>Receive usual care and complete daily logs | Behavioral: usual care<br>* Women in the usual care group will receive primary and oncology care from their doctors as usual, and complete daily logs recording their fatigue and daily functioning levels. They also need to return the logs every week by email or self-addressed envelopes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue (proximal outcome) | The primary outcome will be measured by 6-item PROMIS (Patient-Reported Outcomes Measurement Information System) (e.g., felt tired, exhausted, limited at work). | 8 weeks post-intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese women, Cancer-related fatigue, Acupressure