Table 1 Study assessments
Assessment | Instruments | Visits | ||||
|---|---|---|---|---|---|---|
Baseline | After RT | T6 | T12 | T18b | ||
Heighta, weight, waist and hip circumference, Body Mass Index | Calibrated scales, stadiometer, tape measures | ✓ | ✓ | ✓ | ✓ | ✓ |
Heart rate and blood oxygen saturation | Finger pulse oximeter | ✓ | ✓ | ✓ | ✓ | ✓ |
Total, HDL, LDL cholesterol, triglycerides, glucose, insulin, PSA, and other serum biomarkersc | Blood Sample | ✓ | ✓ | ✓ | ✓ | |
Intestinal microbiome composition | Fecal Sample | ✓ | ✓ | ✓ | ✓ | ✓ |
Body composition | BIVA (Bioelectrical Impedance Vector Analysis – Nutrilab device AKERN Srl – Italy) | ✓ | ✓ | ✓ | ✓ | ✓ |
Food consumption | 16-items Dietary Questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ |
Physical activity | International Physical Activity Questionnaire (IPAQ) | ✓ | ✓ | ✓ | ✓ | ✓ |
Steps | Pedometer-like device (wrist band) | IG | – | CG | – | – |
Quality of Life | Functional Assessment on Cancer Therapy (FACT-P) | ✓ | – | ✓ | ✓ | ✓ |
Self-efficacy | Self-Efficacy Scale (GS-EF) | ✓ | – | ✓ | ✓ | ✓ |
Anxiety | Anxiety Scale for Prostate Cancer (MAX – PC) | ✓ | – | ✓ | ✓ | ✓ |
Life orientation | Life Orientation test (LOT-R) | ✓ | – | ✓ | ✓ | ✓ |
Personality traits | Personal Traits Questionnaire (Con-OR) | ✓ | – | ✓ | ✓ | ✓ |
Patient reported acute and late toxicity | Questionnaire acute and late toxicity | ✓ | ✓ | ✓ | ✓ | ✓ |
Erectile function | International Index of Erectile Function (IEEF) | ✓ | ✓ | ✓ | ✓ | ✓ |
Urinary function | International Prostate Symptoms Score (IPSS), International Consultation on Incontinence Questionnaire (ICIQ-SF) | ✓ | ✓ | ✓ | ✓ | ✓ |
Acute and late toxicity | RTOG/EORTCd | ✓ | ✓ | ✓ | ✓ | ✓ |