Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, 3002 East Melbourne, Vic, Australia.
Trials. 2013 Feb 11;14:39. doi: 10.1186/1745-6215-14-39.
Women who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women's informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis.
METHODS/DESIGN: This multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy.
This timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated.
Australian New Zealand Clinical Trial Registry ACTRN12611000744954.
接受妇科癌症（GC）放射治疗的女性可能会经历令人痛苦的副作用，这会影响她们的社会心理功能和亲密关系。通过全面的治疗准备以及满足女性的信息、身体、心理和性心理需求，可以减轻与癌症相关的痛苦。本文介绍了一项多中心随机对照试验（RCT）的方案，该试验测试了一种新的干预方案，该方案结合了定制的专科护士咨询和电话同伴支持，主要目的是减轻心理困扰。次要目标评估患者的生活质量、症状困扰、未满足的支持性护理需求、治疗准备、性心理功能和阴道狭窄。
方法/设计：这种多方面的干预措施包括四次护士主导的咨询，以及来自同伴支持志愿者（GC 幸存者）的四次电话。该循证干预措施将在疾病轨迹的关键节点提供：治疗前、治疗中期、治疗完成后和治疗后。护士和同伴参加为期两天的强化培训研讨会，遵循综合研究干预手册，并接受持续的监督和支持。符合条件的患者将被诊断为 GC，计划接受根治性放射治疗，年龄在 18 岁或以上，并且会说英语。306 名参与者将被随机分配接受常规护理或常规护理加干预包。研究结果将在基线、放射治疗第 1 天以及放射治疗后 1、6 和 12 个月收集。阴道毒性的临床评估将在基线时以及放射治疗后 3、6 和 12 个月进行。
这项及时的研究有可能大大减少 GC 女性的身体、性心理和支持性护理需求。使用电话同伴支持模式，干预包确保为地理位置偏远的患者提供公平获得支持服务的机会。新的干预措施利用同伴志愿者与护士联系，鼓励他们遵守专业提供的信息，并提供情感支持。它旨在具有潜在的可转移性，可以应用于一系列治疗环境和疾病。根据初步数据，该建议的干预措施被发现对患者和临床医生有用且可接受。如果在多中心 RCT 中有效且可行，该方案可以广泛传播。
澳大利亚新西兰临床试验注册 ACTRN12611000744954。
