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

Cynthia A Thomson; Tracy E Crane; Austin Miller; Michael A Gold; Matthew Powell; Kristin Bixel; Linda Van Le; Paul DiSilvestro; Elena Ratner; Shashikant Lele; Saketh Guntupalli; Warner Huh; Sharon E Robertson; Susan Modesitt; A Catherine Casey; Karen Basen-Engquist; Meghan Skiba; Joan Walker; Lisa Kachnic; David S Alberts

doi:10.1016/j.ygyno.2022.12.017

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

Gynecol Oncol. 2023 Mar:170:11-18. doi: 10.1016/j.ygyno.2022.12.017. Epub 2023 Jan 4.

Authors

Cynthia A Thomson¹, Tracy E Crane², Austin Miller³, Michael A Gold⁴, Matthew Powell⁵, Kristin Bixel⁶, Linda Van Le⁷, Paul DiSilvestro⁸, Elena Ratner⁹, Shashikant Lele¹⁰, Saketh Guntupalli¹¹, Warner Huh¹², Sharon E Robertson¹³, Susan Modesitt¹⁴, A Catherine Casey¹⁵, Karen Basen-Engquist¹⁶, Meghan Skiba¹⁷, Joan Walker¹⁸, Lisa Kachnic¹⁹, David S Alberts²⁰

Affiliations

¹ Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA. Electronic address: [email protected].
² Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA; Division of Medical Oncology, Miller School of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA. Electronic address: [email protected].
³ NRG Oncology, Clinical Trials Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: [email protected].
⁴ Oklahoma Cancer Specialists and Research Institute, Tulsa, OK, USA. Electronic address: [email protected].
⁵ Washington University School of Medicine, St. Louis, MO, USA. Electronic address: [email protected].
⁶ Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute, Columbus, OH, USA. Electronic address: [email protected].
⁷ University of North Carolina School of Medicine, UNC Hospitals, 101 Manning Dr, Chapel Hill, NC, USA. Electronic address: [email protected].
⁸ Women and Infants, 101 Dudley St, Providence, RI, USA. Electronic address: [email protected].
⁹ Yale University School of Medicine, New Haven, CT, USA. Electronic address: [email protected].
¹⁰ Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: [email protected].
¹¹ University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, CO, USA. Electronic address: [email protected].
¹² University of Alabama at Birmingham Hospital, Birmingham, AL, USA. Electronic address: [email protected].
¹³ Indiana University Health Simon Cancer Center, Indianapolis, IN, USA. Electronic address: [email protected].
¹⁴ University of Virginia, Emily Couric Clinical Cancer Center, Charlottesville, VA, USA. Electronic address: [email protected].
¹⁵ US Oncology, Edina Clinic, Edina, Minnesota. Electronic address: [email protected].
¹⁶ Professor of Behavioral Science, Director of the Center for Energy Balance in Cancer Prevention & Survivorship, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. Electronic address: [email protected].
¹⁷ Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA. Electronic address: [email protected].
¹⁸ University of Oklahoma, Oklahoma City, OK, USA. Electronic address: [email protected].
¹⁹ Columbia University, Herbert Irving Comprehensive Cancer Center, New York, NY, USA. Electronic address: [email protected].
²⁰ Medicine, Pharmacology, Public Health, Nutritional Sciences & BIO5, Emeritus, University of Arizona Cancer Center, Tucson, AZ, 85719, USA. Electronic address: [email protected].

Abstract

Objective: 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.

Methods: 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.

Results: 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%.

Conclusion: 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.

Trial registration: ClinicalTrials.govNCT00719303.

Keywords: Cancer survivorship; Diet; Exercise; Fat; Fiber; Fruit; Lifestyle; Nutrition; Ovarian cancer; Physical activity; Progression-free survival; Steps; Vegetables.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Cancer Survivors*
Diet
Exercise
Female
Humans
Life Style
Middle Aged
Ovarian Neoplasms*

Associated data

ClinicalTrials.gov/NCT00719303

Abstract

Publication types

MeSH terms

Associated data

Grants and funding