title: The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach, and may offset, or even reverse, the adverse effects accompanying ADT. Unfortunately, the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects. Consequently, the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer.
  
  
  METHODS
  A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care. Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity, dietary behavior, body composition, muscular strength, and quality of life. Outcomes will be obtained at baseline, 2-month, and 3-month assessments by trial personnel blinded to participants' randomization assignment.
  
  
  CONCLUSIONS
  Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02050906.
authors.affiliation: Exercise and Behavioral Medicine Laboratory, Kinesiology, The Ohio State University, Columbus, OH, USA. focht.10@osu.edu.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Focht
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Lucas
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Grainger
authors.forename: Christina
authors.initials: C
authors.lastname: Simpson
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Thomas-Ahner
authors.forename: Steven K
authors.initials: SK
authors.lastname: Clinton
mesh_terms: D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D005081:Exercise Therapy; D015438:Health Behavior; D006304:Health Status; D006801:Humans; D008297:Male; D009820:Ohio; D010349:Patient Compliance; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000178:diet therapy* / Q000188:drug therapy*; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists