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Trial Title:
Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors
NCT ID:
NCT05615753
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Acupuncture
Description:
All participants will receive a semi-standardized acupuncture protocol with additional
points for patient's particular pain location,
Arm group label:
Acupuncture group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Illinois at Chicago
Address:
City:
Chicago
Zip:
60601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hongjin Li
Email:
hongjin@uic.edu
Start date:
January 12, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
University of Illinois at Chicago
Agency class:
Other
Source:
University of Illinois at Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05615753
