Acupressure for Cancer-Related Fatigue
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupressure intervention
usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Chinese women, Cancer-related fatigue, Acupressure
Eligibility Criteria
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
Sites / Locations
- Georgetown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
acupressure intervention
usual care
Arm Description
Practice acupressure at home and complete daily logs
Receive usual care and complete daily logs
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Physical functioning (distal outcomes)
The secondary outcomes will be measure by 8-item PROMIS (e.g., ability in carrying grocery, kneeling, climbing stairs).
Sleep disturbance
The secondary outcomes will be measure by 6-item PROMIS (e.g., sleep not steady, unsatisfied, hard to fall asleep).
Anxiety
The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).
Depression
The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
Pain interference
The secondary outcomes will be measure by 6-item PROMIS (e.g., affecting ability to focus, interact with others, run errands).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03091647
Brief Title
Acupressure for Cancer-Related Fatigue
Official Title
Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Chinese women, Cancer-related fatigue, Acupressure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupressure intervention
Arm Type
Experimental
Arm Description
Practice acupressure at home and complete daily logs
Arm Title
usual care
Arm Type
Placebo Comparator
Arm Description
Receive usual care and complete daily logs
Intervention Type
Behavioral
Intervention Name(s)
acupressure intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cancer-related fatigue (proximal outcome)
Description
The primary outcome will be measured by 6-item PROMIS (Patient-Reported Outcomes Measurement Information System) (e.g., felt tired, exhausted, limited at work).
Time Frame
8 weeks post-intervention
Secondary Outcome Measure Information:
Title
Physical functioning (distal outcomes)
Description
The secondary outcomes will be measure by 8-item PROMIS (e.g., ability in carrying grocery, kneeling, climbing stairs).
Time Frame
8 weeks post-intervention
Title
Sleep disturbance
Description
The secondary outcomes will be measure by 6-item PROMIS (e.g., sleep not steady, unsatisfied, hard to fall asleep).
Time Frame
8 weeks post-intervention
Title
Anxiety
Description
The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).
Time Frame
8 weeks post-intervention
Title
Depression
Description
The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
Time Frame
8 weeks post-intervention
Title
Pain interference
Description
The secondary outcomes will be measure by 6-item PROMIS (e.g., affecting ability to focus, interact with others, run errands).
Time Frame
8 weeks post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Wang, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acupressure for Cancer-Related Fatigue
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