Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors

NCT ID: NCT05615753

Last Updated: 2025-03-30

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-10-31

Brief Summary

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The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.

Detailed Description

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This study has the following specific aims:

Aim 1: Test the feasibility and acceptability of implementing a 5-week acupuncture intervention within federally qualified health center oncology clinic to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, anxiety) among breast cancer survivors receiving endocrine therapy.

Aim 2: Use a mixed methods approach to identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinic.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Acupuncture group

Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type BEHAVIORAL

All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,

Usual care group

Participants will continue to receive their usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* women with histologically confirmed stage 0, I, II, or III breast cancer
* \> 18 years of old
* who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy
* are able to read and speak English
* with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance).

Exclusion Criteria

* Metastatic breast cancer (stage IV)
* have a bleeding disorder (e.g. hemophilia, Von Willebrand's disease, thrombocytopenia)
* failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study
* Psychiatric or medical disorders which would affect study assessments, such as, dementia, Alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication
* Breastfeeding, pregnant or are planning get pregnant during the study period
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Hongjin Li

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2022-0353

Identifier Type: -

Identifier Source: org_study_id

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