Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors.

The Lifestyle Intervention for oVarian cancer Enhanced Survival (LIVES) is a national study of a combined diet and physical activity intervention for stage II-IV ovarian cancer survival, an under-represented cancer in lifestyle behavioral intervention research. Here, we present the data on recruitment, retention, and baseline demographic, clinical and lifestyle behavior characteristics of the LIVES study participants. The LIVES study (NRG Oncology/GOG 0225) is a Phase III diet plus physical activity intervention trial testing the hypothesis that ovarian cancer survivors in the lifestyle intervention will demonstrate better progression-free survival than those in the control condition. Study interventions were delivered via centralized telephone-based health coaching. Baseline descriptive statistics were computed for demographic, clinical, and lifestyle behavior characteristics. The LIVES study exceeded its recruitment goals, enrolling 1205 ovarian cancer survivors from 195 NRG/NCORP-affiliated oncology practices across 49 states from 2012 to 2018. The mean age of enrollees was 59.6 years; the majority (69.4%) with stage III disease; 89% White, 5.5% Hispanic; 64% overweight/obese. Baseline self-reported diet showed a mean daily intake of 6.6 servings of fruit and vegetables, 62.7 fat grams, and 21.7 g of fiber. Physical activity averaged 13.0 MET-hours/week of moderate to vigorous physical activity; 50.9 h/week of sedentary time. Retention rates exceeded 88%. The LIVES study demonstrates efficiency in recruiting and retaining ovarian cancer survivors in a 24-month study of diet and physical activity intervention with a primary endpoint of progression free survival that will be reported. ClinicalTrials.govNCT00719303.

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Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest Dr. Austin Miller reports that his institution received grants from the following: Vascular Biogenics LTD, Advaxis, Abbvie. Dr. Miller also reports participating on the Steering Committee for AstraZeneca as well as receiving institutional support from both Regeneron and GSK. Dr. Michael Gold received honoraria from ASCCP as an Educational Course Speaker. Dr. Matthew Powell received support from the NIH/NIH to NCTN NRG Oncology Network. Dr. Powell also reports participating on Advisory Boards for the following entities: GSK/Tesaro, Clovis Oncology, Merck, AstraZeneca, Eisai and SeaGen. Dr. Kristin Bixel reports receiving intuitive unrestricted research grant to the GOG for funding of randomized controlled trial (ROCC). Additionally, Dr. Bixel reports serving on Advisory Boards for Intuitive and Merck and receiving honoraria from both of these entities. Dr. Ratner reports receiving consulting fees from Aspire and has stock in same. Dr. Warner Huh reports receiving consulting fees from AstraZeneca and receiving payment for expert testimony from Shook, Hardy & Bacon LLP. Dr. Basen-Engquist reports MPI, R01CA186700, Study of biomarkers in ovarian cancer: Modulation by activity & diet intervention, MD Anderson subcontract from University of Arizona. She also receives grant from NCI, R21CA239079, Reducing breast cancer risk through modifying boy composition and decreasing inflammation in normal weight women. Dr. Basen-Engquist also reports pilot study grant from NCI, R21 CA215410 as well as receiving funding from Cancer Prevention & Research Institute of Texas: PP170023 &PP200028, Active Living After Cancer: Combining a physical activity program with survivor navigation and she received honoraria for Speaking from the both NCI as well as the University of New Mexico Cancer Center, Gynecologic Oncology Group and Yale University for Faculty TREC training program. Dr. Basen-Engquist also reports receiving support for travel from the National Cancer Policy Forum, National Academies of Science, Engineering, and Medicine and Yale University. She also participated as an Independent Safety Monitor for Boston University, digital health supported weight management intervention delivered by community health workers among public housing residents (R01CA238335). Dr. Basen-Engquist reports serving as President of the American Society of Preventive Oncology. Dr. Walker reports serving in a leadership role for NCORP. Dr. Lisa Kachnic reports NCI NCORP Funding and serving as Associate NCORP PI Support and Chair of Cancer Control Support. All other authors have no conflict of interest related to this manuscript.