Wolfson Palliative Care Research Centre, University of Hull, Hull, UK
Leeds Institute of Clinical Trials Research, University of Leeds Clinical Trials Research Unit, Leeds, UK.
BMJ Open. 2022 May 4;12(5):e051394. doi: 10.1136/bmjopen-2021-051394.
Unmet needs in patients with cancer and their carers are common but poorly identified and addressed. The Needs Assessment Tool-Cancer (NAT-C) is a structured consultation guide to identify and triage patient and carer unmet needs. The NAT-C is validated, but its effectiveness in reducing unmet patient and carer needs in primary care is unknown.
Cluster randomised controlled trial with internal pilot and embedded process evaluation to test the clinical and cost effectiveness of the NAT-C in primary care for people with active cancer in reducing unmet patient and carer need, compared with usual care. We will recruit 1080 patients with active cancer (and carers if relevant) from 54 general practices in England.Participating practices will be randomised 1:1 to either deliver an NAT-guided clinical consultation plus usual care or to usual care alone. Consenting participants with active cancer and their carers (if nominated) will be asked to complete study questionnaires at baseline, 1 and 3 months for all, 6 months except for those recruited outside of the last 3 months of recruitment, and attend an NAT-C appointment if allocated to an intervention practice. An internal pilot will assess: site and participant recruitment, intervention uptake and follow-up rates. The primary outcome, the proportion of patients with an unmet need on the Supportive Care Needs Survey Short Form 34 at 3 months postregistration, will be analysed using a multilevel logistic regression. Mixed-methods process evaluation informed by Normalisation Process Theory will use quantitative survey and interview data from clinicians and key stakeholders in cancer care to develop an implementation strategy for nationwide rollout of the NAT-C if the intervention is cost-effective.
Ethical approval from London-Surrey REC (20/LO/0312). Results will be peer-reviewed, published and made available to research participants.
ISRCTN15497400.
癌症患者及其照护者的未满足需求很常见，但往往难以识别和处理。需求评估工具-癌症（NAT-C）是一种结构化的咨询指南，用于识别和分类患者和照护者的未满足需求。NAT-C 经过验证，但它在初级保健中降低癌症患者和照护者未满足需求的有效性尚不清楚。
这是一项具有内部试点和嵌入式过程评估的集群随机对照试验，旨在测试 NAT-C 在初级保健中用于患有活动性癌症的人群的临床和成本效益，以降低未满足的患者和照护者的需求，与常规护理相比。我们将从英格兰的 54 家普通诊所招募 1080 名患有活动性癌症的患者（如果相关，还有照护者）。参与的诊所将以 1:1 的比例随机分配到接受 NAT 指导的临床咨询加常规护理或仅接受常规护理。所有患者和照护者（如果提名）将被要求在基线、1 个月和 3 个月完成研究问卷，除了那些在招募最后 3 个月之外招募的患者，将在 6 个月时完成，并且如果分配到干预诊所，将接受 NAT-C 预约。内部试点将评估：地点和参与者招募、干预接受率和随访率。主要结局是在登记后 3 个月时，有多少患者在支持性护理需求调查短表 34 上有未满足的需求，将使用多级逻辑回归进行分析。基于规范过程理论的混合方法过程评估将使用来自癌症护理临床医生和关键利益相关者的定量调查和访谈数据，为如果干预具有成本效益，则在全国范围内推出 NAT-C 制定实施策略。
伦敦-萨里 REC 批准[伦理编号]。结果将经过同行评审，发表，并提供给研究参与者。
ISRCTN8416641。
