title: Effectiveness of community-based football compared to usual care in men with prostate cancer: Protocol for a randomised, controlled, parallel group, multicenter superiority trial (The FC Prostate Community Trial).
abstract: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer.
  
  
  
  Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy-Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period.
  
  
  
  Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs.
  
  
  
  Clinicaltrials.gov identifier: NCT02430792.
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. eb@ucsf.dk.
authors.forename: Eik
authors.identifier: 0000-0001-9370-5162
authors.initials: E
authors.lastname: Bjerre
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Ditte Marie
authors.initials: DM
authors.lastname: Bruun
authors.affiliation: Department of Mathematical Sciences, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Tolver
authors.affiliation: Copenhagen Prostate Cancer Center, Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Klaus
authors.initials: K
authors.lastname: Brasso
authors.affiliation: Department of Sports Science and Clinical Biomechanics, SDU Sport and Health Sciences Cluster (SHSC), University of Southern Denmark, Odense M, Denmark.|Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Exeter, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Krustrup
authors.affiliation: Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.|Unit of Survivorship, Danish Cancer Society Research Center, Copenhagen, Denmark.
authors.forename: Christoffer
authors.initials: C
authors.lastname: Johansen
authors.affiliation: Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.|Department of Oncology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Mikael
authors.initials: M
authors.lastname: Rørth
authors.affiliation: University Hospitals Centre for Health Research (UCSF), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.|Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Julie
authors.initials: J
authors.lastname: Midtgaard
mesh_terms: D005081:Exercise Therapy; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012916:Soccer; D016896:Treatment Outcome
keywords: Exercise; Physical activity; Prostate cancer; Quality of life; Soccer