Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04392 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00007393 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| WINSHIP6156-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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 OBJECTIVE:
I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence of AI-associated arthralgias (AIAA) among non-Hispanic Black postmenopausal women with stage I-III hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer at 6 months after starting adjuvant AI therapy.
SECONDARY OBJECTIVES:
I. To compare the efficacy of acupuncture to the efficacy of acupressure among the study population.
II. To determine if acupuncture or acupressure will increase AI adherence (secondary endpoint) among the study population at 6 months after starting adjuvant AI therapy.
III. To evaluate the acceptance, satisfaction, convenience, accessibility, and perceptions of in-person acupuncture and virtual acupressure.
IV. To conduct 4 focus groups of 6-12 non-Hispanic Black women who receive 12 weeks of acupuncture or acupressure and collect and analyze qualitative data about barriers and facilitators to completing each intervention, transportation concerns, and ease or difficulty of completing each intervention.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) AI therapy.
ARM II: Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.
ARM III: Patients receive SOC AI therapy.
After completion of study intervention, patients are followed up for 12 months or until the initiation of new antineoplastic or investigational therapy, whichever occurs first.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (acupuncture, AI therapy) | Experimental | Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy. |
|
| Arm II (acupressure, AI therapy) | Experimental | Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy. |
|
| Arm III (AI therapy) | Active Comparator | Patients receive SOC AI therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure Therapy | Procedure | Undergo self-administered acupressure therapy to planned pressure points |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demetria Smith-Graziani, MD, MPH | Contact | 404-712-4834 | demetria.joy.smith-graziani@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Demetria Smith-Graziani, MD,MPH | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Recruiting | Atlanta | Georgia | 30303 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acupuncture Therapy | Device | Undergo acupuncture therapy with acupuncture needles applied to planned pressure points |
|
|
| Aromatase Inhibition Therapy | Drug | Receive SOC AI therapy |
|
|
| Discussion | Other | Ancillary studies |
|
|
| Survey Administration | Other | Ancillary studies |
|
| 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 |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
|
| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Emory Saint Joseph's Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| ID | Term |
|---|---|
| D019050 | Acupressure |
| D015670 | Acupuncture Therapy |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided