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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

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: acupressure intervention Behavioral: usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupressure Intervention to Improve Fatigue and Physical Functioning of Chinese Immigrant Breast Cancer Survivors
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: acupressure intervention
Practice acupressure at home and complete daily logs
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.

Placebo Comparator: usual care
Receive usual care and complete daily logs
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Anxiety [ Time Frame: 8 weeks post-intervention ]
    The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).

  4. Depression [ Time Frame: 8 weeks post-intervention ]
    The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).

  5. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091647


Contacts
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Contact: Judy Wang, Ph.D. 202-687-6306 jw235@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Judy Wang, PhD    202-687-6306    jw235@georgetown.edu   
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Judy Wang, Ph.D. Georgetown University

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Responsible Party: Judy Wang, Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03091647    
Other Study ID Numbers: 2016-0435
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Judy Wang, Georgetown University:
Chinese women
Cancer-related fatigue
Acupressure
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms