Translational Cancer Research Unit, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW Medicine, The University of New South Wales, Liverpool, BC NSW, 2170, Australia.
Health Qual Life Outcomes. 2012 Sep 26;10:119. doi: 10.1186/1477-7525-10-119.
Although it is known both patients' and partners' reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients' partners' reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples' illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD.
METHODS/DESIGN: In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1) Coping-Together or 2) a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety) and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping) will be assessed at baseline (before receiving study material) and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted.
As partners' distress rates exceed not only population norms, but also those reported by patients themselves, it is imperative that coping skills interventions target the couple as a unit and enhance both partners' ability to overcome cancer challenges. This pilot study will examine the feasibility and potential efficacy of Coping-Together in optimising couples' illness adjustment. This is one of the first feasibility studies to test this innovative coping intervention, which in turn will contribute to the larger literature advocating for psychosocial care of couples affected by prostate cancer.
Australian New Zealand Clinical Trials Registry ACTRN12611000438954.
患者及其伴侣对前列腺癌诊断的反应都包括恐惧、不确定、焦虑和抑郁，而且患者伴侣的反应相互决定他们如何应对和适应疾病。尽管有一些针对伴侣的心理社会干预措施，但很少有针对夫妻的干预措施。现有的干预措施往往由经过高度培训的专业人员主导，这限制了它们的可及性和长期可持续性。此外，人们认识到，那些可能受益于传统面对面心理社会干预的患者，由于偏好或地理或流动性障碍，并没有接受这些干预。自我指导的干预措施可以克服这些限制，并已被证明有助于患者的幸福感。本研究将检验一种针对受癌症影响的夫妻的自我指导应对技能干预措施的可行性，称为“共同应对”，并开始探索其对夫妻疾病调整的潜在影响。“共同应对”的试点版本包括一系列四本手册、一张 DVD 和一张放松音频 CD。
方法/设计：在这项双盲、两臂、平行、随机对照试验中，将在前列腺癌诊断后 4 个月内通过泌尿科私人诊所招募 70 对夫妇，并将他们随机分为：1）“共同应对”或 2）最低道德关怀条件。最低道德关怀条件的夫妇将收到邮寄的资料手册，这些手册可在新南威尔士癌症委员会获得，还有一本癌症委员会帮助热线的小册子。主要结局（焦虑）和其他次要结局（困扰、抑郁、夫妻关系调整、生活质量、疾病或护理评估、自我效能以及夫妻和个体应对）将在基线（在接受研究材料之前）和基线后 2 个月进行评估。将进行意向治疗和方案分析。
由于伴侣的困扰率不仅超过了人口正常值，而且超过了患者自己报告的困扰率，因此，应对技能干预措施必须以夫妻为单位，增强双方克服癌症挑战的能力。这项试点研究将检验“共同应对”在优化夫妻疾病调整方面的可行性和潜在疗效。这是第一项测试这种创新应对干预措施的可行性研究之一，这反过来又将为倡导为受前列腺癌影响的夫妻提供心理社会关怀的更大文献做出贡献。
澳大利亚新西兰临床试验注册中心 ACTRN12611000438954。
