Metadata supporting data files in the published article: The LISA randomized trial of a weight loss intervention in postmenopausal breast cancer
Creators: name: Goodwin, Pamela J.
name: Roanne J. Sega
name: Vallis, Michael
name: Ligibel, Jennifer A.
name: Pond, Gregory R.
name: Robidoux, André
name: Findlay, Brian
name: Gralow, Julie R.
name: Mukherjee, Som D.
name: Levine, Mark
name: Pritchard, Kathleen I.
Publisher: name: figshare
Year: 2020
Subjects: Cancer
Medicine
Health Care

description: Obesity has been associated with poor breast cancer (BC) outcomes. In this study, the authors investigated whether a standardized, telephone-based weight loss lifestyle intervention in the adjuvant setting would impact breast cancer outcomes.<br><b>Data access</b>: Dataset <b>LISA.XPT</b> generated during the study, supports figures 2 and 3, and tables 1 and 2 of the published article. This dataset is not publicly available in order to protect patient privacy, but can be made available on request from the Director of the Ontario Clinical Ontology Group (OCOG), Dr. Mark Levine, email address: <b>mlevine@mcmaster.ca</b>. Please refer to the document “<b>Policy-RES-005_2019Oct18_DataSharingStatement (1).pdf</b>” for a full list of conditions for data access. Authors have confirmed that no exemptions apply to this statement. <br><b>Study approval, patient consent and clinical trial identifier:</b> All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee; the primary ethics committee was the Ontario Cancer Research Ethics Board with oversight by the Principal Investigator (PG) at Mount Sinai Hospital, Toronto. Informed consent was obtained from all individual participants included in the study. The ClinicalTrials.gov Identifier is NCT00463489.<br><b>Study aims and methodology</b>: The LISA trial was designed as a definitive Phase III adjuvant trial testing the effect of a lifestyle-based weight loss intervention on disease-free survival (DFS) and overall survival (OS).In this multicenter trial, women were randomized 1:1 to mail-based educationalmaterial alone (control) or combined with a standardized, telephone-based lifestyle intervention that focused on diet, physical activity and behavior, and involved 19 calls over 2 years to achieve up to 10% weight loss. 338 (of 2150 planned) T1-3, N0-3, M0 hormone receptor positive BC patients with body mass index (BMI) ≥24 kg/m<sup>2</sup> receiving adjuvant letrozole were randomized (enrolment ended due to funding loss). The primary outcome was Disease-Free Survival (DFS); secondary outcome was Overall Survival (OS). At 8 years’ median follow-up, in a planned analysis, DFS and OS were compared using the Kaplan-Meier method.<br><b>Data supporting the figures and tables in the published article</b>: Dataset <b>LISA.XPT</b> is a .<b>SAS transport file</b>, and supports figures 2 and 3, and tables 1 and 2 of the published article. The dataset includes disease-free survival, hazard ratios (HRs) for Disease-Free Survival (DFS) and Overall Survival (OS), baseline characteristics of the LISA study population, weight measurements at study entry (baseline), and change in weight during the subsequent 96 months, in patients enrolled onto the Lifestyle Intervention Arm and Education Only Arm.<br><b>Software needed to access data</b>: The SAS software is required to access the LISA.XPT dataset. <br>