Stanciu Marian Andrei, Morris Caroline, Makin Matt, Watson Eila, Bulger Jenna, Evans Richard, Hiscock Julia, Hoare Zoë, Edwards Rhiannon Tudor, Neal Richard D, Yeo Seow Tien, Wilkinson Clare
North Wales Centre for Primary Care Research, Bangor University, Wrexham, UK.
Betsi Cadwaladr University Health Board, Wrexham, UK.
Eur J Cancer Care (Engl). 2019 Mar;28(2):e12966. doi: 10.1111/ecc.12966. Epub 2018 Nov 26.
The present parallel randomised control trial evaluated the feasibility of a nurse-led psycho-educational intervention aimed at improving the self-management of prostate cancer survivors.
We identified 305 eligible patients from a district general hospital, diagnosed 9-48 months previously, who completed radical treatment, or were monitored clinically (ineligible for treatment). Ninety-five patients were recruited by blinded selection and randomised to Intervention (N = 48) and Control (N = 47) groups. Participant allocation was revealed to patients and researchers after recruitment was completed. For 36 weeks, participants received augmented usual care (Control) or augmented usual care and additional nurse support (Intervention) provided in two community hospitals and a university clinic, or by telephone.
Data from 91 participants (Intervention, N = 45; Control, N = 46) were analysed. All feasibility metrics met predefined targets: recruitment rate (31.15%; 95% CI: 25.95%-36.35%), attrition rate (9.47%; 95% CI: 3.58%-15.36%) and outcome measures completion rates (77%-92%). Forty-five patients received the intervention, with no adverse events. The Extended Prostate Cancer Index Composite can inform the minimum sample size for a future effectiveness trial. The net intervention cost was £317 per patient.
The results supported the feasibility and acceptability of the intervention, suggesting that it should be evaluated in a fully powered trial to assess its effectiveness and cost-effectiveness.
本平行随机对照试验评估了由护士主导的心理教育干预措施在改善前列腺癌幸存者自我管理方面的可行性。
我们从一家地区综合医院中确定了305名符合条件的患者，他们在9至48个月前被诊断出患有前列腺癌，已完成根治性治疗，或正在接受临床监测（不适合治疗）。通过盲选招募了95名患者，并随机分为干预组（N = 48）和对照组（N = 47）。招募完成后，向患者和研究人员公布了参与者的分组情况。在36周的时间里，参与者在两家社区医院和一家大学诊所接受了强化常规护理（对照组），或强化常规护理及额外的护士支持（干预组），也可通过电话接受服务。
对91名参与者（干预组，N = 45；对照组，N = 46）的数据进行了分析。所有可行性指标均达到预定目标：招募率（31.15%；95%置信区间：25.95% - 36.35%）、损耗率（9.47%；95%置信区间：3.58% - 15.36%）和结局指标完成率（77% - 92%）。45名患者接受了干预，未出现不良事件。扩展前列腺癌指数综合指标可为未来有效性试验提供最小样本量信息。干预的净成本为每位患者317英镑。
结果支持了该干预措施的可行性和可接受性，表明应在一项充分有力的试验中对其进行评估，以评估其有效性和成本效益。
