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

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)

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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.