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Table 1 Data collection schedule

From: Effects of concentrated long-chain omega-3 polyunsaturated fatty acid supplementation before radical prostatectomy on prostate cancer proliferation, inflammation, and quality of life: study protocol for a phase IIb, randomized, double-blind, placebo-controlled trial

  Initial visit Randomization RP Post-RP follow-up
Eligibility Intervention (baseline - V0) V1 V2 3 mo V3 6 mo V4 9 mo V5 12 mo
Consent   X      
Medical history and health behaviors   X      
Concomitant medication/symptom evaluation   X   X X X X
Consultation with uro-oncologist X    X* X* X* X*
Blood sample including total PSA and lipid profile   X X X X X X
Digital rectal exam and urine sample   X      
Radical prostatectomy (RP)    X     
Food frequency questionnaire - FFQ online   X      X
Prostate specific quality of life (IPSS and EPIC-26)   X   X X X X
Hospital Anxiety and Depression Scale (HADS)   X   X X X X
Quality of life (sleep quality, fatigue, cognitive functioning) (ISI, ISF, FACT-COG V3)   X   X X X X
General health and wellbeing (SF-36)   X   X X X X
Fear of recurrence (FCRI)   X   X X X X
Self-reported sleep diary   X X X X X X
Therapeutic expectation questionnaire     X    X
Anthropometric measurements   X      X
Vital signs£   X   X X X X
  1. RP: Radical Prostatectomy; V: visit; mo: months; PSA: Prostate Specific Antigen; IPSS: International Prostate Symptoms Score; EPIC: Expanded Prostate Index Composite; HADS: Hospital Anxiety and Depression Scale; ISI: Insomnia Severity Index; FSI: Fatigue Symptoms Inventory; Fatigue Symptoms Inventory and Functional Assessment of Cancer Therapy – Cognitive Function (FACT-COGv3); SF-36: Short-Form Health Survey; FCRI: Fear of Recurrence Inventory
  2. *The consultation with the urologist might be on a different day but at the same period
  3. Height, weight, hip and waist circumference, body fat measured by skinfold caliper
  4. £Temperature, blood pressure and pulse