A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer

Rationale and design of the Lifestyle Intervention
 A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study.

Author information

• ¹Mel & Enid Zuckerman College of Public Health, Department of Health Promotion Sciences, University of Arizona, 1295 N. Martin Ave., PO Box 245209, Tucson, AZ 85724-5209, United States. Electronic address: cthomson@email.arizona.edu.
• ²Mel & Enid Zuckerman College of Public Health, Department of Health Promotion Sciences, University of Arizona, 1295 N. Martin Ave., PO Box 245209, Tucson, AZ 85724-5209, United States. Electronic address: tecrane@email.arizona.edu.
• ³NRG Oncology/Gynecologic Oncology Group, Statistics and Data Management Center, Elm & Carlton Streets, Buffalo, NY 14263, United States. Electronic address: amiller@gogstats.org.
• ⁴Mel & Enid Zuckerman College of Public Health, Department of Health Promotion Sciences, University of Arizona, 1295 N. Martin Ave., PO Box 245209, Tucson, AZ 85724-5209, United States. Electronic address: davidogarcia@email.arizona.edu.
• ⁵Department of Behavioral Science, Cancer Prevention and Population Sciences, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, United States. Electronic address: kbasenen@mdanderson.org.
• ⁶University of Arizona Cancer Center, 1515 N. Campbell Ave., Tucson, AZ 85721, United States. Electronic address: dalberts@uacc.arizona.edu.

Abstract

Ovarian cancer is the most common cause of gynecological cancer death in United States women.Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary.Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population.The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer.Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group.Secondary outcomes to be evaluated include QoL and gastrointestinal health.Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS.Blood specimens are collected at baseline, 6, 12 and 24months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length).Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches.A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture.When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors.