Margarita Santiago-Torres1, Isobel Contento2, Pamela Koch2, Wei-Yann Tsai3, Adam M Brickman4, Ann Ogden Gaffney5, Cynthia A Thomson6, Tracy E Crane7, Naxielly Dominguez5, Jhack Sepulveda8, Amanda M Marín-Chollom9, Rachel Paul10, Zaixing Shi11, Kathleene T Ulanday12, Christiane Hale13, Dawn Hershman14, Heather Greenlee15. 1. Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. 2. Teachers College, Columbia University, New York, NY, USA. 3. Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA. 4. Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA. 5. Cook for Your Life, New York, NY, USA. 6. Mel & Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA. 7. College of Nursing, University of Arizona, Tucson, AZ, USA. 8. Eat Good Consulting Inc., New York, NY, USA. 9. Department of Psychological Science, Central Connecticut State University, Connecticut, CT, USA. 10. Rachel Paul Nutrition LLC, New York, NY, USA. 11. State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen, China. 12. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA. 13. Columbia University Irving Medical Center, New York, NY, USA. 14. College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA. 15. Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: hgreenlee@fredhutch.org.
Abstract
BACKGROUND: Most Latina breast cancer survivors do not meet diet and physical activity (PA) guidelines for cancer survivors and effective lifestyle interventions to adopt and maintain these recommendations are limited, especially among underserved populations. Here we describe the design, methods and enrollment of a 2 × 2 factorial-designed trial testing the separate effects of the ¡Mi Vida Saludable! (My Healthy Life!) intervention program on changes in diet and PA behaviors among Latina breast cancer survivors. METHODS: Latinas with a history of stage 0-III breast cancer, no evidence of recurrent/metastatic disease, and > 90 days post-treatment were primarily identified via cancer registries and physician referral. Participants were randomized to four arms: 1) 4 weeks of in-person group sessions plus 11 months of eHealth communication, 2) in-person group sessions alone, 3) eHealth alone, or 4) control. All participants received a Fitbit to self-monitor PA. Assessments at baseline, 6 and 12 months include diet, PA, anthropometrics, predictors and mediators of behavior change, psychosocial and quality of life outcomes, and blood draw. RESULTS: Of 884 women screened between January 2016 and September 2018, 27% were eligible. Primary reasons for ineligibility included not being willing/able to participate due to work/life responsibilities, health reasons, or transportation. Of 241 eligible women, 167 completed baseline assessment and enrolled. CONCLUSIONS: We successfully enrolled a diverse group of breast cancer survivors representing more than 15 Latin American nationalities to a diet and physical activity trial. If effective, the ¡Mi Vida Saludable! program can be implemented by community groups and medical centers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02780271, registered May 2016.
RCT Entities:
BACKGROUND: Most Latina breast cancer survivors do not meet diet and physical activity (PA) guidelines for cancer survivors and effective lifestyle interventions to adopt and maintain these recommendations are limited, especially among underserved populations. Here we describe the design, methods and enrollment of a 2 × 2 factorial-designed trial testing the separate effects of the ¡Mi Vida Saludable! (My Healthy Life!) intervention program on changes in diet and PA behaviors among Latina breast cancer survivors. METHODS: Latinas with a history of stage 0-III breast cancer, no evidence of recurrent/metastatic disease, and > 90 days post-treatment were primarily identified via cancer registries and physician referral. Participants were randomized to four arms: 1) 4 weeks of in-person group sessions plus 11 months of eHealth communication, 2) in-person group sessions alone, 3) eHealth alone, or 4) control. All participants received a Fitbit to self-monitor PA. Assessments at baseline, 6 and 12 months include diet, PA, anthropometrics, predictors and mediators of behavior change, psychosocial and quality of life outcomes, and blood draw. RESULTS: Of 884 women screened between January 2016 and September 2018, 27% were eligible. Primary reasons for ineligibility included not being willing/able to participate due to work/life responsibilities, health reasons, or transportation. Of 241 eligible women, 167 completed baseline assessment and enrolled. CONCLUSIONS: We successfully enrolled a diverse group of breast cancer survivors representing more than 15 Latin American nationalities to a diet and physical activity trial. If effective, the ¡Mi Vida Saludable! program can be implemented by community groups and medical centers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02780271, registered May 2016.
Authors: Amanda M Marín-Chollom; Christiane Hale; Pamela Koch; Ann Ogden Gaffney; Isobel Contento; Hanjie Shen; Dawn L Hershman; Adam M Brickman; Heather Greenlee Journal: J Immigr Minor Health Date: 2021-10-28
Authors: Isobel Contento; Rachel Paul; Amanda M Marin-Chollom; Ann Ogden Gaffney; Jhack Sepulveda; Naxielly Dominguez; Heewon Gray; Anne M Haase; Dawn L Hershman; Pamela Koch; Heather Greenlee Journal: Cancer Control Date: 2022 Jan-Dec Impact factor: 2.339
Authors: Karen H Kim Yeary; Nikia Clark; Frances Saad-Harfouche; Deborah Erwin; Margaret Gates Kuliszewski; Qiang Li; Susan E McCann; Han Yu; Catherine Lincourt; Jamie Zoellner; Li Tang Journal: JMIR Cancer Date: 2022-02-15