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一项针对前列腺癌幸存者的定制电子生存护理计划:一项多中心随机对照试验。

A Tailored Electronic Survivorship Care Plan for Prostate Cancer Survivors: A Multicenter Randomized Controlled Trial.

作者信息

Jones Jennifer M, Matthew Andrew, Tanguay Simon, Higano Celestia S, Goldenberg Larry, Howell Doris, Maganti Manjula

机构信息

Department of Supportive Care, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Division of Urology, McGill University, Montreal, Quebec, Canada.

出版信息

J Urol. 2025 Apr;213(4):407-416. doi: 10.1097/JU.0000000000004359. Epub 2024 Dec 20.

Abstract

PURPOSE

Although the provision of a survivorship care plan (SCP) has been recommended after prostate cancer (PCa) treatment, there have been no randomized controlled trials to examine their impact. The objective of this study was to evaluate the effect of a tailored PCa-SCP intervention provided to early-stage PCa survivors.

MATERIALS AND METHODS

A prospective, parallel 1:1 randomized controlled trial was conducted at 3 sites across Canada. Early-stage PCa survivors were randomized (n = 189; 64% response rate) to receive PCa-SCP intervention or usual care. Assessments were performed at baseline, 6 months, and 12 months. The primary outcome was change in patient activation (Patient Activation Measure-13); secondary outcomes included satisfaction with information, self-management support, prostate-specific quality of life, cancer worry, health care utilization, and health behaviors.

RESULTS

For the primary patient activation analyses, no significant group-by-time differences were detected. There were significant between-group differences in (1) satisfaction with information from baseline to 6 months (mean [95% CI]: 7.13 [5.53-8.71]; effect size [ES], 0.34; < .001) and baseline to 12 months (4.91 [3.06, 7.06]; ES, 0.19; < .001); (2) social integration and support from baseline to 6 months (mean [95% CI]: 0.16 [0.06-0.26]; ES, 0.25; = .002); and (3) skill and technique acquisition from baseline to 6 months (mean [95% CI]: 0.12 [-0.02 to 0.24]; ES, 0.33; = .05). No other group-by-time differences were detected.

CONCLUSIONS

The PCa-SCP intervention did not have a significant effect on patient activation but did increase satisfaction with information and some aspects of self-management support. Although the benefits of the provision of an SCP alone remain unclear, the PCa-SCP intervention is likely a valuable tool that can be built upon as part of a comprehensive approach to enhance the quality of care for PCa survivors.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03017456.

摘要

目的

尽管在前列腺癌(PCa)治疗后推荐提供生存护理计划(SCP),但尚无随机对照试验来检验其影响。本研究的目的是评估为早期PCa幸存者提供量身定制的PCa-SCP干预措施的效果。

材料与方法

在加拿大的3个地点进行了一项前瞻性、平行1:1随机对照试验。早期PCa幸存者被随机分组(n = 189;应答率64%),以接受PCa-SCP干预或常规护理。在基线、6个月和12个月时进行评估。主要结局是患者激活度的变化(患者激活度测量-13);次要结局包括对信息的满意度、自我管理支持、前列腺特异性生活质量、癌症担忧、医疗保健利用和健康行为。

结果

对于主要的患者激活度分析,未检测到显著的组间时间差异。在以下方面存在显著的组间差异:(1)从基线到6个月对信息的满意度(均值[95%CI]:7.13[5.53 - 8.71];效应大小[ES],0.34;P <.001)以及从基线到12个月(4.91[3.06, 7.06];ES,0.19;P <.001);(2)从基线到6个月的社会融合与支持(均值[95%CI]:0.16[0.06 - 0.26];ES,0.25;P =.002);以及(3)从基线到6个月的技能和技术获取(均值[95%CI]:0.12[-0.02至0.24];ES,0.33;P =.05)。未检测到其他组间时间差异。

结论

PCa-SCP干预对患者激活度没有显著影响,但确实提高了对信息的满意度以及自我管理支持的某些方面。尽管单独提供SCP的益处仍不明确,但PCa-SCP干预可能是一种有价值的工具,可作为综合方法的一部分加以完善,以提高PCa幸存者的护理质量。

试验注册

ClinicalTrials.gov标识符:NCT03017456。

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