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前列腺癌男性患者的偏好评估与治疗决策:Healium 的随机对照试验结果

Preference Elicitation and Treatment Decision-Making Among Men Diagnosed With Prostate Cancer: Randomized Controlled Trial Results of Healium.

机构信息

Institute of Health System Science, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, United States.

Cancer Prevention and Control Program, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, United States.

出版信息

J Med Internet Res. 2023 Oct 20;25:e46552. doi: 10.2196/46552.

DOI:10.2196/46552
PMID:37862103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10625066/
Abstract

BACKGROUND

Elicitation of patients' preferences is an integral part of shared decision-making, the recommended approach for prostate cancer decision-making. Existing decision aids for this population often do not specifically focus on patients' preferences. Healium is a brief interactive web-based decision aid that aims to elicit patients' treatment preferences and is designed for a low health literate population.

OBJECTIVE

This study used a randomized controlled trial to evaluate whether Healium, designed to target preference elicitation, is as efficacious as Healing Choices, a comprehensive education and decision tool, in improving outcomes for decision-making and emotional quality of life.

METHODS

Patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief Healium intervention or Healing Choices, a decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. Assessments were completed at baseline, 6 weeks, and 3 months post baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, and preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

RESULTS

A total of 327 individuals consented to participate in the study (171 were randomized to the Healium intervention arm and 156 were randomized to Healing Choices). The majority of the sample was non-Hispanic (272/282, 96%), White (239/314, 76%), married (251/320, 78.4%), and was on average 62.4 (SD 6.9) years old. Within both arms, there was a significant decrease in decisional conflict from baseline to 6 weeks postbaseline (Healium, P≤.001; Healing Choices, P≤.001), and a significant increase in satisfaction with one's decision from 6 weeks to 3 months (Healium, P=.04; Healing Choices, P=.01). Within both arms, anxiety/tension (Healium, P=.23; Healing Choices, P=.27) and depression (Healium, P=.001; Healing Choices, P≤.001) decreased from baseline to 6 weeks, but only in the case of depression was the decrease statistically significant.

CONCLUSIONS

Healium, our brief decision aid focusing on treatment preference elicitation, is as successful in reducing decisional conflict as our previously tested comprehensive decision aid, Healing Choices, and has the added benefit of brevity, making it the ideal tool for integration into the physician consultation and electronic medical record.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05800483; https://clinicaltrials.gov/study/NCT05800483.

摘要

背景

患者偏好的引出是共同决策的一个组成部分,这是前列腺癌决策的推荐方法。现有的针对该人群的决策辅助工具通常并没有特别关注患者的偏好。Healium 是一种简短的互动式网络决策辅助工具,旨在引出患者的治疗偏好,专为低健康素养人群设计。

目的

本研究采用随机对照试验来评估 Healium 是否与 Healing Choices 一样有效,Healing Choices 是一种综合的教育和决策工具,可改善决策结果和情绪生活质量。

方法

被诊断为局限性前列腺癌且尚未做出治疗决策的患者被随机分配到简短的 Healium 干预组或 Healing Choices 组,后者是我们小组之前开发的一种决策辅助工具,用作前列腺癌诊断和治疗的虚拟信息中心。在基线、6 周和 3 个月时完成评估,包括决策结果(决策冲突、决策满意度和决策准备度)和情绪生活质量(焦虑/紧张和抑郁),以及人口统计学、合并症和健康素养。

结果

共有 327 人同意参与研究(171 人随机分配到 Healium 干预组,156 人随机分配到 Healing Choices 组)。样本中的大多数是非西班牙裔(272/282,96%)、白人(239/314,76%)、已婚(251/320,78.4%),平均年龄为 62.4(SD 6.9)岁。在两个臂中,决策冲突从基线到 6 周后均显著降低(Healium,P≤.001;Healing Choices,P≤.001),对决策的满意度从 6 周增加到 3 个月(Healium,P=.04;Healing Choices,P=.01)。在两个臂中,焦虑/紧张(Healium,P=.23;Healing Choices,P=.27)和抑郁(Healium,P=.001;Healing Choices,P≤.001)从基线到 6 周时均降低,但只有在抑郁方面,下降具有统计学意义。

结论

Healium 是我们专注于治疗偏好引出的简短决策辅助工具,与我们之前测试的综合决策辅助工具 Healing Choices 一样成功地降低了决策冲突,并且具有简洁的优点,使其成为整合到医生咨询和电子病历中的理想工具。

试验注册

ClinicalTrials.gov NCT05800483;https://clinicaltrials.gov/study/NCT05800483。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b37c/10625066/8c8b5e5374a8/jmir_v25i1e46552_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b37c/10625066/8c8b5e5374a8/jmir_v25i1e46552_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b37c/10625066/8c8b5e5374a8/jmir_v25i1e46552_fig1.jpg

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