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

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University of Illinois

Status and phase

Enrolling
Phase 1

Conditions

Breast Cancer

Treatments

Behavioral: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT05615753
2022-0353

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Acupuncture group
Experimental group
Description:
Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.
Treatment:
Behavioral: Acupuncture
Usual care group
No Intervention group
Description:
Participants will continue to receive their usual care.

Trial contacts and locations

0

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Central trial contact

Hongjin Li, PhD; Hongjin Li

Data sourced from clinicaltrials.gov

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