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Title: Design and outcomes of a feasibility randomised controlled trial of lifestyle weight loss intervention in women treated for breast cancer
Author: Newlands, Rumana
ISNI:       0000 0004 6062 5301
Awarding Body: University of Aberdeen
Current Institution: University of Aberdeen
Date of Award: 2016
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Introduction: Breast cancer is the most frequent cancer among women worldwide. Breast cancer treatments and treatment-related factors (type, dose, duration, and side-effects) have been found to be associated with weight gain in women. Overweight and obesity, in breast cancer survivors, is associated with increased risk of breast cancer-specific and all-cause mortality. Prognosis may be improved by maintaining a healthy weight but research in weight management in women treated for breast cancer is relatively limited. Aim: To design a weight loss trial for women treated for breast cancer and to evaluate its feasibility, and effect on body weight and quality of life (QoL). Methods: The development and evaluation of the trial was guided by the Medical Research Council framework for developing and evaluating complex interventions and involved mixed methods research. The development involved a systematic review of 13 randomised controlled trials (RCTs) targeting weight loss in women treated for breast cancer, and a mixed methods study [focus group meetings (n= 15), survey (n= 139), and interviews (n=20)] with the target population to understand their experiences and future preferences of a weight loss programme. The findings of these preliminary studies informed the design of a feasibility RCT of weight loss intervention. Results: 45 women (age 41-89 y; BMI 25.1–66.2 kg/m2) previously treated for breast cancer were randomly allocated to three groups: Weight Watchers vouchers for 12 weeks plus 5 dietitian-led support groups (WW plus: n=14); Weight Watchers vouchers only (WW: n=16) or waiting-list control (Weight Watchers vouchers after 3 months) (controls: n=15). Weight and QoL were measured at 0 and 12 weeks and data was available for 38 (84%) participants at 12 weeks. The trial was found to be feasible and acceptable for weight loss in this population. The controls, WW plus and WW group showed median (IQR) weight change of 0.07 (-0.4, 0.7) kg (p= 0.666), -2.90 (-6.5, -2.2) kg (p= 0.002) and -5.90 (-6.6, -5.1) kg (p= 0.001) respectively (between groups, p = 0.001). The regression model suggested that compared to participants in WW plus, participants in WW group lost significantly more weight (2.6 kg; 95% CI -0.38, -4.86) and control group participants lost significantly less weight (3.8 kg; 95% CI, 1.47, 6.16) over the 12 weeks. There were a number of significant improvements in different QoL scores in the intervention groups at 12 weeks. However, a significant difference in median (IQR) scores of the breast cancer specific QoL scale was observed between the three groups (p= 0.017) and it was higher in WW group [5.0 (1.5, 7.5)] compared to WW plus group [3.7 (2.0, 4.5)] and control [0.5 (-2.0, 2.2)]. Conclusions: The outcomes of this theoretically informed trial suggest that providing WW vouchers for overweight and obese women treated for breast cancer is feasible and shows promise for weight loss and improved QoL.
Supervisor: Not available Sponsor: Fraserburgh Moonlight Prowl ; Cancer Research Aberdeen and North East Scotland (CRANES)
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available
Keywords: Breast ; Overweight women ; Weight loss ; Clinical trials