This clinical trial evaluates if in-person acupuncture or virtual acupressure therapy prevents aromatase inhibitor-associated joint pain in Non-Hispanic Black postmenopausal women with stage I-III (early-stage) hormone receptor positive (HR+) breast cancer. Aromatase inhibitors (AI) are medications that prevent the formation of the hormone estrogen. They are used in the treatment of postmenopausal women who have hormone-dependent breast cancer. AI therapy prolongs life among patients with early-stage HR+ breast cancer. Many postmenopausal women stop AI therapy early due to debilitating joint pain (arthralgias). Non-Hispanic Black women are more likely to experience side effects and stop their hormonal therapy compared to Non-Hispanic white women. Acupuncture therapy involves inserting thin needles through the skin at specific points on the body to control pain. Acupressure therapy uses the application of pressure or localized massage to specific sites on the body to control symptoms such as pain. Acupuncture and acupressure are types of complementary and alternative medicine. Undergoing in-person acupuncture or participating in virtual acupressure may prevent AI-associated arthralgias (AIAA) in Non-Hispanic Black postmenopausal women with early-stage HR+ breast cancer.
Age ≥ 18 years
Self-identified Non-Hispanic Black woman
Postmenopausal status (>= 12 months since last menstrual period, history of bilateral salpingo-oophorectomy, or estradiol, follicle-stimulating hormone [FSH], and luteinizing hormone [LH] levels consistent with menopause)
Diagnosed with stage I-III HR+/HER2 negative (-) breast cancer
Diagnosed with metastatic breast cancer
Premenopausal status
History of allergic reactions attributed to compounds of similar chemical or biologic composition to acupuncture needles or other agents used in study
Diagnosis of rheumatoid arthritis, multiple sclerosis, or muscular dystrophy
Parallel
Acupressure Therapy
Procedure/SurgeryUndergo self-administered acupressure therapy to planned pressure points
Acupuncture Therapy
DeviceUndergo acupuncture therapy with acupuncture needles applied to planned pressure points
Aromatase Inhibition Therapy
DrugReceive SOC AI therapy
Discussion
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Brief pain inventory (BPI) pain severity score
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI severity score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point versus (vs) \< 1 point increase in pain severity) in order to determine the incidence of aromatase inhibitor-associated arthralgias (AIAA) and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
Incidence of arthralgias
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
Pain severity
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
Incidence of arthralgias
Pain will be assessed by the BPI-Short Form. Pain severity is rated from 0-10 with higher scores indicating worse pain. Will measure change in BPI score from baseline as an absolute value and a percentage. Will also measure pain as a dichotomous variable (increase in BPI score \>= 1 point vs \< 1 point increase in pain severity) in order to determine the incidence of AIAA and compare the incidence between study arms at 24 weeks. Participants can also list all pain medications they are taking. Will verify this information in their medical records.
AI adherence
Will be assessed by electronic medical record and patient report. Longitudinal data measured repeatedly over time will be modeled by the generalized linear model (GENMOD) with hypothesis testing on the trend of assessment change over time or probability of developing AIAA over time among the three arms.
Symptom burden
Will be assessed by the Functional Assessment of Cancer Symptoms- Endocrine Symptoms score. The Functional Assessment of Cancer Symptoms - Endocrine Symptoms (FACT-ES) is a 46-item validated survey that assesses physical well-being, social/family well-being, emotional well-being, functional well-being, and common symptoms associated with endocrine therapy among cancer patients \> 18 years old receiving endocrine treatments. Each question is on a 5-point Likert scale. A higher composite score correlates to a better quality of life.
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Emory University
Lead sponsor
Bristol-Myers Squibb
Collaborator
National Cancer Institute (NCI)
Collaborator
