Clinical trial NCT05615753: Feasibility of Implementing Acupuncture Into Federally Qualified Health Center Among Breast Cancer Survivors
Official title: Feasibility of Implementing Acupuncture Into a Federally Qualified Health Center to Alleviate Multiple Symptoms Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

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

Primary outcomes:
measure: Acceptability for Treating Multiple Symptoms with Acupuncture
timeFrame: At week 6 after finishing the 10th acupuncture treatment
measure: The numbers of study participants being recruited and retained (Feasibility)
timeFrame: : from the activation of the study to the completion of the recruitment, week 12
measure: Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: