Auricular Point Acupressure to Self-Manage Chronic Pain or Aromatase Inhibitor Musculoskeletal Symptoms in Breast Cancer Survivors: Effectiveness and Scientific Underpinnings
Aromatase Inhibitor, Musculoskeletal Symptoms, Postmenopausal Breast Cancer Survivors
About this trial
This is an interventional treatment trial for Aromatase Inhibitor focused on measuring Breast Cancer Survivors, Aromatase Inhibitor, Ecological Momentary Assessment, Musculoskeletal Symptoms
Eligibility Criteria
Inclusion Criteria:
- Women with a history of Breast Cancer (non-metastatic) before entering into postmenopausal age
- Currently receiving AIs (anastrazole, letrozole, exemestane) per chart documentation for at least 2 months (the peak onset of AIMSS is 1.6 months).
- Able to read and write English
- Have joint pain attributable to AI-or had pre-existing joint pain that worsened after the initiation of AIs-and had worst joint pain rated as 4 or more on a 0-10 numeric rating scale in the previous week
- Are willing to commit to weekly study visits for 4 weeks during the intervention and monthly follow-up visits for 3 months (up to 4 months)
- Able to apply pressure to the seeds taped to the ears
Exclusion Criteria:
- Metastatic breast cancer
- Completed cytotoxic chemotherapy or radiation therapy less than 4 weeks prior to enrollment (because chemotherapy and radiation therapy can cause temporary exacerbation of joint symptoms that typically resolve spontaneously)
- Bone fracture/surgery of an affiliated extremity during the preceding 6 months
- Current use of corticosteroids or narcotics
- Ear skin disease
- Allergy to the tape used for this study
- Having had previous auricular therapy (because they would be unable to be blinded for the study)
- Having been hospitalized for mental health reasons within the last 3 months
- Piercings on the ear points for treatment
Sites / Locations
- Johns Hopkins School of Nursing
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
Other
Auricular Point Acupressure (APA)
Sham APA control
Education Control
Patients with active points related to Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS). The points for AIMSS include (1) points corresponding to body pain location and (2) three points known for alleviating stress and pain (i.e., shenmen, sympathetic, and nervous subcortex)
The same procedure of APA will be applied but the tapes/seeds will be placed on different points (points not related to AIMSS). Participants in the Sham APA Control will receive APA on the five ear points comprising mouth, stomach, duodenum, internal ear, and tonsils. These points are chosen for the Sham APA Control for two reasons: First, they are distinct from the zones of the ear (and the points therein) associated with AIMSS and correspond to body regions in which BCS (Breast Cancer Survivors) are usually pain-free; second, they are equivalent in number to those points used in the APA treatment group and no negative impacts have been observed among these points in our pilot study.
Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Educational sessions are intended to reflect usual standard medical care per guidelines from the American Society of Clinical Oncology (ASCO), while also meeting the needs of trial participation, including (1) the knowledge of hormonal therapy and side effects; (2) assessment and management of physical long-term and late effects; (3) assessment and management of psychological long-term and late effects; and (4) dietary (developed by Co-I, van Londen) and physical activity in Breast Cancer Survivors (BCS) (developed by Co-I, Stearns). These materials have been used by the research team, and clinical practice. Materials will be tailored so that they can be delivered within 15 minutes for each session.