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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615753
• Other study ID #: 2022-0353
• Status: Recruiting
• Phase: Phase 1
• Start date: January 12, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2023
• Source: University of Illinois at Chicago
• Contact: Hongjin Li, PhD
• Phone: 3124139845
• Email: hongjin[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At week 6 after finishing the 10th acupuncture treatment
Primary	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	: from the activation of the study to the completion of the recruitment, week 12
Primary	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.	Through study completion, an average of 1 year