Supplementary Material for: Development and validation of the PREVES-HOR Questionnaire: a patient-reported measure of hormone-therapy–related quality of life in prostate-cancer patients undergoing androgen-deprivation therapy

Background. The burden of androgen-deprivation therapy (ADT) is only partially captured by legacy prostate-cancer questionnaires, which devote few items to hormonal sequelae. PREVES-HOR is a 29-item, distress-anchored instrument developed to quantify androgen deprivation therapy (ADT)-specific physical, emotional, cognitive, sexual and body-image morbidity from a patient-centered, subjective perspective. We report the pre-specified Phase-1 psychometric evaluation.
Methods. Italian-speaking men receiving ADT were consecutively enrolled. Participants completed PREVES-HOR plus external comparators for fatigue (REST), mood (HEAL-BDLC), sleep (PEACE) and well-being (WHO-5). Internal consistency was estimated with Cronbach’s α and McDonald’s ω; convergent validity with Spearman correlations; dimensionality with exploratory factor analysis (polychoric matrix, principal-axis factoring, oblimin rotation, parallel analysis).
Results. One-hundred-forty-five patients were analyzed. PREVES-HOR showed excellent reliability (α = 0.95; McDonald’s ω = 0.97; domain α/ω 0.80–0.95). Six factors—Physical Fatigue & Pain, Emotional Well-being, Mental Clarity, Quality of Life, Relationships and Stress, Sexual Health and Body-Image—accounted for 79 % of variance, with a dominant general-distress factor (~50 %). All but four items had communalities ≥ 0.40 and cross-loadings < 0.30. Total PREVES-HOR correlated strongly with fatigue (REST ρ = 0.69) and depression/anxiety (HEAL-BDLC ρ = 0.78), and inversely with well-being (WHO-5 ρ = –0.49) and sleep quality (PEACE ρ = –0.37), confirming convergent but non-redundant validity.
Conclusions. Phase-1 findings support PREVES-HOR’s content validity, internal coherence and ability to detect clinically meaningful distress overlooked by broader instruments such as EPIC or FACT-P. Its forced-choice format eliminated missing data but will be reconsidered, along with responsiveness, test–retest stability and cross-cultural adaptation, in the ongoing 1,000-patient Phase-2/3 program. Pending confirmation, PREVES-HOR may become a complementary tool for individualizing supportive care and evaluating ADT-modifying interventions.