NCT03091647

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

March 17, 2017

Last Update Submit

February 1, 2021

Conditions

Breast Cancer

Keywords

Chinese womenCancer-related fatigueAcupressure

Outcome Measures

Primary Outcomes (1)

  • 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).

    8 weeks post-intervention

Secondary Outcomes (5)

  • Physical functioning (distal outcomes)

    8 weeks post-intervention

  • Sleep disturbance

    8 weeks post-intervention

  • Anxiety

    8 weeks post-intervention

  • Depression

    8 weeks post-intervention

  • Pain interference

    8 weeks post-intervention

Study Arms (2)

acupressure intervention

EXPERIMENTAL

Practice acupressure at home and complete daily logs

Behavioral: acupressure intervention

usual care

PLACEBO COMPARATOR

Receive usual care and complete daily logs

Behavioral: usual care

Interventions

acupressure interventionBEHAVIORAL

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.

acupressure intervention
usual careBEHAVIORAL

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.

usual care

Eligibility Criteria

Age21 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) be between ages 21 to 74
  • \) be first-generation immigrants
  • \) speak Chinese (Mandarin and/or Cantonese)
  • \) be diagnosed with breast cancer at stage 0, I, II III or IV
  • \) have completed primary treatments (including surgery, radiation, and chemotherapy) 1-5 years prior to recruitment
  • \) have not had recurrence
  • \) have moderate to severe levels of fatigue.

You may not qualify if:

  • have hypothyroidism and anemia
  • being using acupuncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Judy Wang, Ph.D.

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 27, 2017

Study Start

July 1, 2016

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

US(1)