title: Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients.
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.
authors.affiliation: Columbia University Medical Center, New York, USA. Electronic address: hg2120@columbia.edu.
authors.forename: Heather
authors.initials: H
authors.lastname: Greenlee
authors.affiliation: Columbia University Medical Center, New York, USA.
authors.forename: Katherine D
authors.initials: KD
authors.lastname: Crew
authors.affiliation: Mount Sinai Medical Center, New York, USA.
authors.forename: Jillian
authors.initials: J
authors.lastname: Capodice
authors.affiliation: Columbia University Medical Center, New York, USA.
authors.forename: Danielle
authors.initials: D
authors.lastname: Awad
authors.affiliation: Columbia University Medical Center, New York, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Jeffres
authors.affiliation: SWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, USA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Unger
authors.affiliation: SWOG Statistical Center/Fred Hutchinson Cancer Research Center, Seattle, USA.
authors.forename: Danika L
authors.initials: DL
authors.lastname: Lew
authors.affiliation: Legacy Health System, Portland, USA.
authors.forename: Lisa K
authors.initials: LK
authors.lastname: Hansen
authors.affiliation: University of California at Irvine, Orange, USA.
authors.forename: Frank L
authors.initials: FL
authors.lastname: Meyskens
authors.affiliation: Cancer Care Specialists of Central Illinois/Heartland NCORP, Decatur, USA.
authors.forename: James L
authors.initials: JL
authors.lastname: Wade
authors.affiliation: Columbia University Medical Center, New York, USA.
authors.forename: Dawn L
authors.initials: DL
authors.lastname: Hershman
mesh_terms: D047072:Aromatase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D018771:Arthralgia / Q000209:etiology* / Q000628:therapy*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic / Q000592:standards
chemical_list: D047072:Aromatase Inhibitors
keywords: acupuncture; aromatase inhibitor; breast cancer; clinical trial; multisite; randomized controlled trial