Acupressure for Cancer-Related Fatigue

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03091647
• Other study ID #: 2016-0435
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2021
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Behavioral:
• acupressure 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.
• usual 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.

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Anxiety	The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).	8 weeks post-intervention
Secondary	Depression	The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).	8 weeks post-intervention
Secondary	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