Acupressure for Cancer-Related Fatigue

February 1, 2021 updated by: Judy Wang, Georgetown University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks post-intervention
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).
8 weeks post-intervention
Anxiety
Time Frame: 8 weeks post-intervention
The secondary outcomes will be measure by 7-item PROMIS (e.g., felt anxious, nervous, fearful, tense).
8 weeks post-intervention
Depression
Time Frame: 8 weeks post-intervention
The secondary outcomes will be measure by 8-item PROMIS (e.g., felt helpless, depressed, unhappy, hopeless).
8 weeks post-intervention
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).
8 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Judy Wang, Ph.D., Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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