Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women With Early-Stage Breast Cancer
NCT Number: NCT06534125
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|HER2-Negative Breast Carcinoma|Hormone Receptor-Positive Breast Carcinoma
Interventions: PROCEDURE: Acupressure Therapy|DEVICE: Acupuncture Therapy|DRUG: Aromatase Inhibition Therapy|OTHER: Discussion|OTHER: Survey Administration
Sponsor: Emory University
Collaborators: Bristol-Myers Squibb|National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: Grady Health System, Atlanta, Georgia, 30303, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Emory Saint Joseph's Hospital, Atlanta, Georgia, 30342, United States

Summary:
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.

Primary Outcome Measures: 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., Baseline to 6 months after aromatase inhibitor (AI) start|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., Baseline to 6 months after AI start
Secondary Outcome Measures: 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., Baseline to 6 months after starting study intervention|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., Baseline to 6 months after starting study intervention|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., Baseline to 6 months after starting study intervention|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., Baseline to 6 months after starting study intervention|Intervention completion rate, Will track the number of acupuncture or acupressure sessions that study participants successfully complete., At 6 months after starting study intervention|Participant satisfaction rate, Will be assessed by the Client Satisfaction Questionnaire (CSQ-4). Will assess the intervention impact on satisfaction level, difficulty of completing interventions, and perceived benefit of the interventions at the primary time point at weeks 24, as well as their change pattern over time. A higher score indicates more satisfaction. Will conduct 4 focus groups (2 per intervention arm) of 12 patients each, stratified by intervention type (acupuncture vs acupressure) and clinic site, which is believed to be sufficient to reach saturation of themes. For qualitative focus groups, will use conventional content analysis methods. In-depth focus groups will be audio-recorded and professionally transcribed., At 6 months after starting study intervention|Perceived difficulty of completing study intervention, Will be assessed by the CSQ-4. Will assess the intervention impact on satisfaction level, difficulty of completing interventions, and perceived benefit of the interventions at the primary time point at weeks 24, as well as their change pattern over time. A higher score indicates more satisfaction. Will conduct 4 focus groups (2 per intervention arm) of 12 patients each, stratified by intervention type (acupuncture vs acupressure) and clinic site, which is believed to be sufficient to reach saturation of themes. For qualitative focus groups, will use conventional content analysis methods. In-depth focus groups will be audio-recorded and professionally transcribed., At 6 months after starting study intervention