Acupressure for Cancer-Related Fatigue

NCT ID: NCT03091647

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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acupressure intervention

Practice acupressure at home and complete daily logs

Group Type EXPERIMENTAL

acupressure intervention

Intervention Type BEHAVIORAL

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

Receive usual care and complete daily logs

Group Type PLACEBO_COMPARATOR

usual care

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Judy Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judy Wang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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2016-0435

Identifier Type: -

Identifier Source: org_study_id

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