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Acupressure for Cancer-Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091647
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Judy Wang, Georgetown University

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE July 1, 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Cancer-related fatigue (proximal outcome) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03091647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • Physical functioning (distal outcomes) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks post-intervention ]
    The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).
  • Depression [ Time Frame: 8 weeks post-intervention ]
    The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
  • Pain interference [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupressure for Cancer-Related Fatigue
Official Title  ICMJE Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: acupressure intervention
    Practice acupressure at home and complete daily logs
    Intervention: Behavioral: acupressure intervention
  • Placebo Comparator: usual care
    Receive usual care and complete daily logs
    Intervention: Behavioral: usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Judy Wang, Ph.D. 202-687-6306 jw235@georgetown.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03091647
Other Study ID Numbers  ICMJE 2016-0435
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Judy Wang, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judy Wang, Ph.D. Georgetown University
PRS Account Georgetown University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP