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.

IF 1.8 3区 医学 Q3 ONCOLOGY
Oncology Pub Date : 2025-09-29 DOI:10.1159/000548317
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.

PREVES-HOR问卷的开发和验证:患者报告的前列腺癌患者接受雄激素剥夺治疗的激素治疗相关生活质量的测量。
背景:雄激素剥夺治疗(ADT)的负担仅部分被遗留前列腺癌问卷所捕获,其中很少有关于激素后遗症的项目。PREVES-HOR是一项29项、以痛苦为锚定的工具,旨在从以患者为中心的主观角度量化雄激素剥夺治疗(ADT)特异性身体、情绪、认知、性和身体形象的发病率。我们报告预先指定的第一阶段心理测量评估。方法:意大利语患者接受ADT治疗。参与者完成了PREVES-HOR以及疲劳(REST)、情绪(HEAL-BDLC)、睡眠(PEACE)和幸福感(WHO-5)的外部比较。采用Cronbach’s α和McDonald’s ω估计内部一致性;Spearman相关的收敛效度;维度与探索性因子分析(多共时矩阵,主轴分解,oblimin旋转,平行分析)。结果:共分析145例患者。preaves - hor具有优异的信度(α = 0.95; McDonald's ω = 0.97; domain α/ω 0.80-0.95)。六个因素——身体疲劳和疼痛、情绪健康、精神清晰、生活质量、人际关系和压力、性健康和身体形象——占变异的79%,其中一个主要的普遍困扰因素(约50%)。除4个项目外,其余项目的群落≥0.40,交叉负荷< 0.30。总PREVES-HOR与疲劳(REST ρ = 0.69)和抑郁/焦虑(healb - dlc ρ = 0.78)强烈相关,与幸福感(WHO-5 ρ = -0.49)和睡眠质量(PEACE ρ = -0.37)呈负相关,证实了收敛但非冗余的效度。结论:第一阶段的研究结果支持PREVES-HOR的内容效度、内部一致性和检测被更广泛的工具(如EPIC或FACT-P)忽视的有临床意义的痛苦的能力。它的强制选择格式消除了缺失的数据,但在正在进行的1000名患者的2/3期项目中,将重新考虑响应性、重测稳定性和跨文化适应性。在确认之前,PREVES-HOR可能成为个体化支持性护理和评估adt修饰干预措施的补充工具。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Oncology
Oncology 医学-肿瘤学
CiteScore
6.00
自引率
2.90%
发文量
76
审稿时长
6-12 weeks
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.
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