Men diagnosed with localised prostate cancer, who were due to undergo radical prostatectomy, were invited to participate in the Cohort Phase of the trial. They each completed a questionnaire booklet and wore an accelerometer for one week before and after radical prostatectomy. A factorial randomised controlled trial design was then used to randomly allocate men to a nutrition and physical activity intervention for a 6-month period. This meant that all men were randomly allocated to one of the nutritional interventions and one of the physical activity interventions. The nutritional intervention was either a plant-based diet (i.e. daily servings of 5 portions of fruit and vegetables and reducing dairy milk intake), or consuming lycopene supplements (10mg once a day), or usual diet (nutrition control arm). The physical activity intervention consisted of a daily 30-minute brisk walk or usual daily physical activity (PA control arm). Intervention outcome measures were assessed using questionnaires, accelerometers, pedometers (baseline, 3-months, and 6-months), and blood samples (baseline and 6-months). A subsample of men (n=17) were invited for interview soon after completing the trial.
Recruitment to the trial is now complete and in December 2017 data collection had finished. Over 100 men were recruited into the Cohort Phase and the majority (n=81) were retained and randomised to the interventions following radical prostatectomy. The trial had very good retention of participants over 6 months with only six men lost to follow-up. The initial results have shown that men found these interventions feasible and acceptable. Other beneficial outcomes from the interventions have been identified from the qualitative findings. These findings have been submitted for publication in peer-reviewed journals. Analysis of the quantitative primary and secondary outcomes are in progress and will be published in high quality journals.
The trial has identified practical and behavioural ways to help men adhere to nutrition and physical activity interventions. These findings will help to inform a larger trial powered to identify the clinical benefits of these interventions for men post-surgery.
Written by: Luke Robles, PhD, School of Social and Community Medicine, University of Bristol, UK; Lucy Hackshaw-McGeagh, PhD, DHealthPsych, CPsychol, NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, Oral and Dental Sciences, University of Bristol, UK; Raj Persad, ChM, FRCS (Eng.), FRCS (Urol), FEBU, Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Bristol, UK
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