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

NCT05615753 | Completed Phase 1 DMC

• 1 other identifier: 2022-0353
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

Participants will continue to receive their usual care.

Interventions

Acupuncture BEHAVIORAL

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

Acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 14, 2022
• Study Start: January 12, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)