Living well after breast cancer randomized controlled trial protocol: Evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer

View/ Open
Author(s)
Reeves, Marina M
Terranova, Caroline O
Erickson, Jane M
Job, Jennifer R
Brookes, Denise SK
McCarthy, Nicole
Hickman, Ingrid J
Lawler, Sheleigh P
Fjeldsoe, Brianna S
Healy, Genevieve N
Winkler, Elisabeth AH
Janda, Monika
Veerman, J Lennert
Ware, Robert S
Prins, Johannes B
Vos, Theo
Demark-Wahnefried, Wendy
Eakin, Elizabeth G
Year published
2016
Metadata
Show full item recordAbstract
Background: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast
cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight
loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few
studies have examined the benefits of such interventions on a broad range of outcomes and few have examined
factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes,
cost-effectiveness). The Living Well after Breast Cancer ...
View more >Background: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Methods/design: Women (18–75 years; body mass index 25–45 kg/m2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. Discussion: This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. (Continued on next page)
View less >
View more >Background: Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Methods/design: Women (18–75 years; body mass index 25–45 kg/m2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of intervention effects. Discussion: This trial will provide evidence needed to inform the wide-scale provision of weight loss, physical activity and dietary interventions as part of routine survivorship care for breast cancer survivors. (Continued on next page)
View less >
Journal Title
BMC Cancer
Volume
16
Issue
1
Copyright Statement
© The Author(s) 2016. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Note
Page numbers are not for citation purposes. Instead, this article has the unique article number of 830.
Subject
Oncology and Carcinogenesis not elsewhere classified
Oncology and Carcinogenesis
Public Health and Health Services