Skip to main content
OpenTrials
Completed

NCT Number: NCT05615753

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Behavioral

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

Primary outcomes

  1. Acceptability for Treating Multiple Symptoms with Acupuncture

    Time frame: 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.

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

    Time frame: : 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.