Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients

Heather Greenlee; Katherine D. Crew; Jillian Capodice; Danielle Awad; Anne Jeffres; Joseph M. Unger; Danika L. Lew; Lisa K. Hansen; Frank L. Meyskens; James L. Wade; Dawn L. Hershman

doi:10.1016/j.jams.2015.03.006

Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients

Heather Greenlee^*, Katherine D. Crew, Jillian Capodice, Danielle Awad, Anne Jeffres, Joseph M. Unger, Danika L. Lew, Lisa K. Hansen, Frank L. Meyskens, James L. Wade, Dawn L. Hershman

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

Robust methods are needed to efficiently conduct large, multisite, randomized, controlled clinical trials of acupuncture protocols. The Southwest Oncology Group (SWOG) S1200 trial is a randomized, controlled (i.e., sham-controlled and waitlist-controlled) trial of a standardized acupuncture protocol for treating aromatase inhibitor (AI)-associated arthralgias in early-stage breast cancer patients (n=228). The primary objective of this study was to determine whether true acupuncture administered twice weekly for 6 weeks, as compared to sham acupuncture or a waitlist control, reduced AI-associated joint pain at 6 weeks as assessed by patient reports. The study was conducted at 11 institutions across the United States. The true acupuncture protocol was developed using a consensus-based process. The true acupuncture and the sham acupuncture protocols each consisted of 12 sessions administered for 6 weeks, followed by one weekly session for 6 weeks. The true acupuncture protocol used standardized protocol points, and the standardized acupoints were tailored to a patient's joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of nonacupoints. Standardized methods were developed to train and monitor acupuncturists and included online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. The research staff similarly received online and in-person training and monthly phone calls.

Original language	English (US)
Pages (from-to)	152-158
Number of pages	7
Journal	JAMS Journal of Acupuncture and Meridian Studies
Volume	8
Issue number	3
DOIs	https://doi.org/10.1016/j.jams.2015.03.006
State	Published - Jun 1 2015

Funding

This research is supported by the following centers of the US National Institutes of Health: National Center for Complementary and Integrative Health, the Office of Research on Women's Health R01AT006376 (to DLH), and the National Cancer Institute Community Oncology Research Program Research Base (grant number 1UG1CA189974-01 ). The Southwest Oncology Group (SWOG) S1200 study—officially named, Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer—is funded by the following centers of the United States (US) National Institutes of Health (NIH): National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), and Office of Research on Women's Health (R01 AT006376). The study is being conducted within the SWOG NCI Community Oncology Research Program (NCORP) Research Base (1UG1CA189974-01) ( www.swog.org/Visitors/AboutUs.asp ). The SWOG network includes > 4000 researchers at > 650 institutions, which include 24 NCI-designated cancer centers and additional international cancer centers. The S1200 study is a limited institution trial that is open at 11 institutions, which constitute 28 clinical sites within the SWOG network.

Keywords

Acupuncture
Aromatase inhibitor
Breast cancer
Clinical trial
Multisite
Randomized controlled trial

ASJC Scopus subject areas

Complementary and alternative medicine
Anesthesiology and Pain Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Greenlee, H., Crew, K. D., Capodice, J., Awad, D., Jeffres, A., Unger, J. M., Lew, D. L., Hansen, L. K., Meyskens, F. L., Wade, J. L., & Hershman, D. L. (2015). Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients. JAMS Journal of Acupuncture and Meridian Studies, 8(3), 152-158. https://doi.org/10.1016/j.jams.2015.03.006

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abstract = "Robust methods are needed to efficiently conduct large, multisite, randomized, controlled clinical trials of acupuncture protocols. The Southwest Oncology Group (SWOG) S1200 trial is a randomized, controlled (i.e., sham-controlled and waitlist-controlled) trial of a standardized acupuncture protocol for treating aromatase inhibitor (AI)-associated arthralgias in early-stage breast cancer patients (n=228). The primary objective of this study was to determine whether true acupuncture administered twice weekly for 6 weeks, as compared to sham acupuncture or a waitlist control, reduced AI-associated joint pain at 6 weeks as assessed by patient reports. The study was conducted at 11 institutions across the United States. The true acupuncture protocol was developed using a consensus-based process. The true acupuncture and the sham acupuncture protocols each consisted of 12 sessions administered for 6 weeks, followed by one weekly session for 6 weeks. The true acupuncture protocol used standardized protocol points, and the standardized acupoints were tailored to a patient's joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of nonacupoints. Standardized methods were developed to train and monitor acupuncturists and included online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. The research staff similarly received online and in-person training and monthly phone calls.",

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Greenlee, H, Crew, KD, Capodice, J, Awad, D, Jeffres, A, Unger, JM, Lew, DL, Hansen, LK, Meyskens, FL, Wade, JL & Hershman, DL 2015, 'Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients', JAMS Journal of Acupuncture and Meridian Studies, vol. 8, no. 3, pp. 152-158. https://doi.org/10.1016/j.jams.2015.03.006

Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients. / Greenlee, Heather; Crew, Katherine D.; Capodice, Jillian et al.
In: JAMS Journal of Acupuncture and Meridian Studies, Vol. 8, No. 3, 01.06.2015, p. 152-158.

Research output: Contribution to journal › Article › peer-review

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AU - Greenlee, Heather

AU - Crew, Katherine D.

AU - Capodice, Jillian

AU - Awad, Danielle

AU - Jeffres, Anne

AU - Unger, Joseph M.

AU - Lew, Danika L.

AU - Hansen, Lisa K.

AU - Meyskens, Frank L.

AU - Wade, James L.

AU - Hershman, Dawn L.

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AB - Robust methods are needed to efficiently conduct large, multisite, randomized, controlled clinical trials of acupuncture protocols. The Southwest Oncology Group (SWOG) S1200 trial is a randomized, controlled (i.e., sham-controlled and waitlist-controlled) trial of a standardized acupuncture protocol for treating aromatase inhibitor (AI)-associated arthralgias in early-stage breast cancer patients (n=228). The primary objective of this study was to determine whether true acupuncture administered twice weekly for 6 weeks, as compared to sham acupuncture or a waitlist control, reduced AI-associated joint pain at 6 weeks as assessed by patient reports. The study was conducted at 11 institutions across the United States. The true acupuncture protocol was developed using a consensus-based process. The true acupuncture and the sham acupuncture protocols each consisted of 12 sessions administered for 6 weeks, followed by one weekly session for 6 weeks. The true acupuncture protocol used standardized protocol points, and the standardized acupoints were tailored to a patient's joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of nonacupoints. Standardized methods were developed to train and monitor acupuncturists and included online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. The research staff similarly received online and in-person training and monthly phone calls.

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KW - Breast cancer

KW - Clinical trial

KW - Multisite

KW - Randomized controlled trial

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Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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