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Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial

机译:为大肠癌幸存者评估由护士领导的生存护理包(SurvivorCare):一项随机对照试验的研究方案

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Background Colorectal cancer (CRC) is the most common cancer affecting both men and women in Australia. The illness and related treatments can cause distressing adverse effects, impact on emotional and psychological well-being, and adversely affect social, occupational and relationship functioning for many years after the end of treatment or, in fact, lifelong. Current models of follow-up fail to address the complex needs arising after treatment completion. Strategies to better prepare and support survivors are urgently required. We previously developed a nurse-led supportive care program (SurvivorCare) and tested it in a pilot study involving 10 CRC survivors. The intervention was found to be highly acceptable, appropriate, relevant and useful. Methods/design This study is a multisite, randomised controlled trial, designed to assess the impact of the addition of the SurvivorCare intervention to usual post-treatment care, for people with potentially cured CRC. SurvivorCare comprises the provision of survivorship educational materials, a tailored survivorship care plan, an individually tailored nurse-led, face-to-face end of treatment consultation and three subsequent telephone calls. Eligible patients have completed treatment for potentially cured CRC. Other eligibility criteria include stage I to III disease, age greater than 18 years and adequate understanding of English. All consenting patients complete questionnaires at three time points over a six-month period (baseline, two and six months). Measures assess psychological distress, unmet needs and quality of life. Discussion This supportive care package has the potential to significantly reduce individual suffering, whilst reducing the burden of follow-up on acute cancer services through enhanced engagement with and utilisation of general practitioners and community based services. If the intervention is successful in achieving the expected health benefits, it could be disseminated readily. All training and supporting materials have been developed and standardised. Furthermore, the intervention could easily be adapted to other cancer or chronic disease settings. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12610000207011 .
机译:背景结直肠癌(CRC)是影响澳大利亚男性和女性的最常见癌症。该疾病和相关治疗可能会导致令人痛苦的不利影响,影响情绪和心理健康,并在治疗结束后的许多年或实际上终生影响社会,职业和人际关系。当前的随访模型无法满足治疗完成后出现的复杂需求。迫切需要采取战略,以更好地准备和支持幸存者。我们先前制定了由护士主导的支持性护理计划(SurvivorCare),并在一项涉及10名CRC幸存者的试点研究中对其进行了测试。发现该干预措施是高度可接受的,适当的,相关的和有用的。方法/设计这项研究是一项多站点,随机对照试验,旨在评估对于可能治愈的CRC患者而言,将SurvivorCare干预措施添加到常规治疗后护理中的影响。 SurvivorCare包括提供生存教育材料,量身定制的生存护理计划,量身定制的由护士主导,面对面的治疗结束咨询以及随后的三个电话。符合条件的患者已完成可能治愈的CRC的治疗。其他资格标准包括I至III期疾病,年龄大于18岁以及对英语的充分理解。所有同意的患者在六个月内的三个时间点(基线,两个月和六个月)完成问卷调查。措施评估心理困扰,未满足的需求和生活质量。讨论该支持性护理方案有可能显着减少个人痛苦,同时通过加强与全科医生和社区服务的接触和利用,减轻急性癌症服务的随访负担。如果干预措施成功实现了预期的健康益处,则可以很容易地进行传播。所有培训和支持材料均已开发并标准化。此外,该干预措施可以轻松地适应其他癌症或慢性疾病的情况。试验注册澳大利亚新西兰临床试验注册ACTRN12610000207011。

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