Breast Cancer
Conditions
Keywords
Chinese women, Cancer-related fatigue, Acupressure
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.
Interventions
BEHAVIORALacupressure intervention
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.
BEHAVIORALusual care
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.
Sponsors
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Anxiety | 8 weeks post-intervention | The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense). |
| 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). |
Countries
United States
Outcome results
None listed