title: 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.
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.
authors.affiliation: Mel & 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.
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Thomson
authors.affiliation: Mel & 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.
authors.forename: Tracy E
authors.initials: TE
authors.lastname: Crane
authors.affiliation: NRG Oncology/Gynecologic Oncology Group, Statistics and Data Management Center, Elm & Carlton Streets, Buffalo, NY 14263, United States. Electronic address: amiller@gogstats.org.
authors.forename: Austin
authors.initials: A
authors.lastname: Miller
authors.affiliation: Mel & 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.
authors.forename: David O
authors.initials: DO
authors.lastname: Garcia
authors.affiliation: Department 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.
authors.forename: Karen
authors.initials: K
authors.lastname: Basen-Engquist
authors.affiliation: University of Arizona Cancer Center, 1515 N. Campbell Ave., Tucson, AZ 85721, United States. Electronic address: dalberts@uacc.arizona.edu.
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000073116:Cancer Survivors; D004035:Diet Therapy / Q000379:methods; D018752:Diet, Fat-Restricted / Q000379:methods*; D004043:Dietary Fiber; D018572:Disease-Free Survival; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008019:Life Style; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000473:pathology / Q000628:therapy*; D010349:Patient Compliance; D011788:Quality of Life; D014675:Vegetables; D055815:Young Adult
chemical_list: D004043:Dietary Fiber
keywords: Behavior; Cancer survival; Clinical trial; Diet; Ovarian cancer; Physical activity