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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Acupuncture

• Registration Number: NCT05615753
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2023-01-12
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Acceptability for Treating Multiple Symptoms with Acupuncture	At week 6 after finishing the 10th acupuncture treatment	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.
The numbers of study participants being recruited and retained (Feasibility)	: from the activation of the study to the completion of the recruitment, week 12	The numbers of study participants being recruited and retained during the study period will be documented as planned
Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States