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一项针对前列腺癌患者及其伴侣的自我管理心理社会干预的随机对照试验:研究方案。

A randomized controlled trial of a self-management psychosocial intervention for men with prostate cancer and their partners: a study protocol.

机构信息

Institute of Nursing and Health Research, University of Ulster, Newtownabbey, UK.

出版信息

J Adv Nurs. 2013 Nov;69(11):2572-83. doi: 10.1111/jan.12132. Epub 2013 Mar 25.

DOI:10.1111/jan.12132
PMID:23528148
Abstract

BACKGROUND

Little is known about interventions to help men and their partners cope with the after effects of prostate cancer treatment. The lack of in-depth descriptions of the intervention content is hindering the identification of which intervention (or component of an intervention) works.

AIM

To describe the development and evaluation of the content of a self-management psychosocial intervention for men with prostate cancer and their partners.

DESIGN

A feasibility randomized controlled trial including structure, process, and outcome analysis.

METHODS

This 9-week intervention commences on completion of treatment and consists of three group and two telephone sessions. The intervention focuses on symptom management, sexual dysfunction, uncertainty management, positive thinking and couple communication. Forty-eight couples will be assigned to either the intervention or a control group receiving usual care. Participants will be assessed at baseline, immediately postintervention and at 1 and 6 months postintervention. Outcome measures for patients and caregivers include self-efficacy, quality of life, symptom distress, uncertainty, benefits of illness, health behaviour, and measures of couple communication and support. An additional caregiver assessment will be completed by the partner.

DISCUSSION

The main purpose of this feasibility study is to investigate the acceptability of the CONNECT programme to men with prostate cancer and their partners and to gain feedback from the participants and facilitators to make changes to and enhance the programme. Reasons why men do not want to participate will be collated to enhance recruitment in the future. We will also test recruitment strategies, randomization procedures, and the acceptability of the questionnaires. Ethical approval granted December 2010.

摘要

背景

对于帮助男性及其伴侣应对前列腺癌治疗后影响的干预措施,我们知之甚少。由于缺乏对干预内容的深入描述,我们难以确定哪种干预措施(或干预措施的组成部分)有效。

目的

描述针对前列腺癌男性及其伴侣的自我管理心理社会干预措施的制定和评估过程。

设计

一项包含结构、过程和结果分析的可行性随机对照试验。

方法

该 9 周干预措施在治疗完成后开始,包括三次小组和两次电话会议。该干预措施侧重于症状管理、性功能障碍、不确定性管理、积极思考和夫妻沟通。将 48 对夫妇随机分配到干预组或对照组,接受常规护理。参与者将在基线、干预后立即以及干预后 1 个月和 6 个月进行评估。患者和护理人员的评估指标包括自我效能、生活质量、症状困扰、不确定性、疾病益处、健康行为以及夫妻沟通和支持的测量。伴侣还将完成一项额外的护理人员评估。

讨论

这项可行性研究的主要目的是调查 CONNECT 方案对前列腺癌男性及其伴侣的可接受性,并从参与者和 facilitators 处获得反馈意见,以对方案进行修改和加强。未参与的男性的原因将被收集起来,以便在未来改进招募。我们还将测试招募策略、随机化程序和问卷的可接受性。于 2010 年 12 月获得伦理批准。

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