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CompletedNCT05615753Updated Mar 30, 2025

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

A Phase 1 interventional study of Acupuncture in Breast Cancer, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by University of Illinois at Chicago · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 62 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Acupuncture

  • No intervention
    Usual care group

    Participants will continue to receive their usual care.

Interventions

  • BehavioralAcupuncture

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

06

What researchers measure

Primary outcomes

  1. Acceptability for Treating Multiple Symptoms with Acupuncture

    Protocol Acceptability Scale is a 9-item instrument with scores ranging from 0 to 18 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions, divided the total score for the 9 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.

    Time frame: At week 6 after finishing the 10th acupuncture treatment

  2. The numbers of study participants being recruited and retained (Feasibility)

    The numbers of study participants being recruited and retained during the study period will be documented as planned

    Time frame: : from the activation of the study to the completion of the recruitment, week 12

  3. Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.

    Specific questions will be asked during a face-to-face interview to identify factors favoring or barriers to implementing acupuncture into federally qualified health center oncology clinics among breast cancer survivors and providers.

    Time frame: Through study completion, an average of 1 year

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Study locations

1 site
  • University of Illinois at Chicago
    Chicago, Illinois 60601, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05615753
Lead sponsor
University of Illinois at Chicago
Responsible party
Hongjin Li (Assistant Professor, University of Illinois at Chicago) — Principal investigator
First posted
Nov 14, 2022
Start date
Jan 12, 2023
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Mar 30, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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