Int J Gynecol Cancer. 2018 Feb;28(2):401-411. doi: 10.1097/IGC.0000000000001179.
This study aimed to evaluate the feasibility of completing a parallel-group randomized controlled trial to compare usual follow-up care for women who have completed treatment of gynecological cancer against a nurse-led telephone intervention, known as Optimal Personalised Care After Treatment-Gynaecological.
The unblinded trial aimed to recruit patients who had completed treatment of cervical, endometrial, epithelial ovarian, or vulval cancer within the previous 3 months at 3 North Wales hospitals. We randomized participants to either usual hospital-based follow-up or specialist nurse-led telephone education, empowerment, and structured needs assessment follow-up. The primary outcomes assessed the feasibility of running a larger trial including patient eligibility, recruitment and retention rates, and outcome measure completion. Secondary outcomes were generic and health-related quality of life and a patient self-report health service use (Client Service Receipt Inventory) data collected at 3 time points (baseline, 3 months, and 6 months).
Of the 58 women screened, 44 were eligible (76%) and 24 (55%) were recruited and randomized (12:12 to control and intervention, respectively). One participant was lost to follow-up. Recruited participants had a mean (SD) age of 60 (11.2) years and were approximately 5 months from their initial diagnosis (mean [SD], 159 [58] days). Seventeen (71%) of the participants had an endometrial cancer diagnosis. All outcome measure completion rates exceeded 96%. Although not a core feasibility objective, analyses of outcome measures indicated positive changes in quality of life and well-being within the Optimal Personalised Care After Treatment-Gynaecological group; exploratory cost consequence analysis indicated that the nurse-led intervention had a mean total service use cost of £27 per patient (bootstrapped 95% confidence interval, -£290 to £240) lower than did the standard care group.
Eligibility, recruitment, and retention rates as well as outcome measure completion showed that the trial is feasible.
本研究旨在评估完成一项平行组随机对照试验的可行性，该试验比较了接受妇科癌症治疗后接受常规随访护理的女性与接受护士主导的电话干预（称为 Optimal Personalised Care After Treatment-Gynaecological）的女性。
这项非盲试验旨在招募在过去 3 个月内在北威尔士 3 家医院接受宫颈癌、子宫内膜癌、上皮性卵巢癌或外阴癌治疗的患者。我们将参与者随机分配到常规的基于医院的随访或专科护士主导的电话教育、赋权和结构化需求评估随访。主要结局评估了开展更大规模试验的可行性，包括患者的合格性、招募和保留率以及结局测量的完成情况。次要结局是一般和健康相关的生活质量以及患者自我报告的健康服务使用情况（客户服务收据清单），这些数据在 3 个时间点（基线、3 个月和 6 个月）收集。
在筛选出的 58 名女性中，有 44 名符合条件（76%），有 24 名（55%）被招募并随机分配（对照组和干预组各 12 名和 12 名）。1 名参与者失访。招募的参与者平均（标准差）年龄为 60（11.2）岁，距初次诊断约 5 个月（平均[标准差]，159[58]天）。17 名（71%）参与者患有子宫内膜癌。所有结局测量的完成率均超过 96%。尽管这不是核心可行性目标，但对结局测量的分析表明，Optimal Personalised Care After Treatment-Gynaecological 组的生活质量和幸福感有了积极的变化；探索性成本后果分析表明，护士主导的干预比标准护理组的每位患者总服务使用成本平均低 27 英镑（ bootstrap 95%置信区间，-290 至 240）。
合格性、招募、保留率以及结局测量的完成情况表明，该试验是可行的。
