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.
Giuseppe Di Lorenzo, Antonio Verde, Luca Scafuri, Raffaele Baio, Francesco Grillone, Francesco Passaro, Felice Crocetto, Dario Bruzzese, Antonella Ferraioli, Eleonora Monteleone, Sabrina Rossetti, Vittorino Montanaro, Giacomo Metta, Francesco Prata, Antonio Ruffo, Giuseppe Romeo, Raffaele Balsamo, Armando Calogero, Oriana Strianese, Francesco Maiorino, Alfredo Tartarone, Matteo Ferro, Pierluigi Bove, Aniello Donnarumma, Paolo Verze, Rocco Papalia, Sisto Perdonà, Vittorio Riccio, Emma Costa, Concetta Scocca, Antonio Aliberti, Francesca Cappuccio, Carlo Buonerba
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引用次数: 0
Abstract
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.
期刊介绍:
Although laboratory and clinical cancer research need to be closely linked, observations at the basic level often remain removed from medical applications. This journal works to accelerate the translation of experimental results into the clinic, and back again into the laboratory for further investigation. The fundamental purpose of this effort is to advance clinically-relevant knowledge of cancer, and improve the outcome of prevention, diagnosis and treatment of malignant disease. The journal publishes significant clinical studies from cancer programs around the world, along with important translational laboratory findings, mini-reviews (invited and submitted) and in-depth discussions of evolving and controversial topics in the oncology arena. A unique feature of the journal is a new section which focuses on rapid peer-review and subsequent publication of short reports of phase 1 and phase 2 clinical cancer trials, with a goal of insuring that high-quality clinical cancer research quickly enters the public domain, regardless of the trial’s ultimate conclusions regarding efficacy or toxicity.