Breast Cancer
Conditions
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.
Interventions
BEHAVIORALAcupuncture
All participants will receive a semi-standardized acupuncture protocol with additional points for patient's particular pain location,
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability for Treating Multiple Symptoms with Acupuncture | At week 6 after finishing the 10th acupuncture treatment | 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. |
| The numbers of study participants being recruited and retained (Feasibility) | : from the activation of the study to the completion of the recruitment, week 12 | The numbers of study participants being recruited and retained during the study period will be documented as planned |
| Identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinics. | Through study completion, an average of 1 year | 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. |
Countries
United States
Outcome results
None listed