Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
BJOG. 2018 Dec;125(13):1705-1714. doi: 10.1111/1471-0528.15396. Epub 2018 Aug 6.
To test the hypothesis that patient-initiated follow up reduces the fear of cancer recurrence (FCR) and healthcare use when compared with traditional hospital-based follow up.
Pragmatic, multicentre randomised trial.
Four Danish departments of gynaecology between May 2013 and May 2016.
One hundred and fifty-six women diagnosed with International Federation of Gynecology and Obstetrics (FIGO) stage I low-intermediate risk endometrial carcinoma.
Women allocated to the control group attended hospital-based follow up consisting of regular outpatient visits for 3 years after primary treatment. Women in the intervention group were instructed in patient-initiated follow up, which included careful instruction in alarm symptoms and options for self-referral rather than a schedule of examinations.
The primary end point was FCR as measured by the Fear of Cancer Recurrence Inventory (FCRI) after 10 months of follow up. Secondary end points included cancer-related use of primary and secondary health care during the first 10 months after treatment.
In the primary analysis, FCR decreased significantly more in the control group from baseline to 10 months of follow up (difference -5.9, 95% CI -10.9 to -0.9). The majority of this improvement happened after only 3 months of follow up. Women receiving the intervention had fewer examinations at the department compared with the control group (0 versus 2 median visits, P < 0.01) and 58% of these examinations were scheduled because of vaginal bleeding.
Hospital-based follow up alleviates FCR significantly more than patient-initiated follow up, though the estimated difference was small. Patient-initiated follow up is a feasible, potentially cost-reducing follow-up approach in a population of endometrial cancer survivors with low risk of recurrence. The decision to use patient-initiated follow up should balance these benefits and harms.
Patient-initiated follow up reduces healthcare use but maintains fear of recurrence in endometrial cancer.
Why and how was the study carried out? Follow up of women with endometrial cancer is resource consuming and previous research suggests that it is not effective. Even though the women benefit from reassurance at follow up, routine examinations may also remind the women of the disease and induce fear of cancer recurrence. Furthermore, routine follow up may delay recurrence diagnosis, because the women do not report their symptoms until the next scheduled visit. In the research explained in this article, patient-initiated follow up was evaluated as an alternative to traditional follow up. The women were randomly assigned to one of two follow-up programmes: regular gynaecological examinations at the department of gynaecology or self-referral with careful instruction in alarm symptoms, that is, patient-initiated follow up. The level of fear of cancer recurrence in the two groups was obtained by questionnaires. Information on healthcare use was obtained by questionnaires and a chart review. What were the main findings? Regular examinations at the department of gynaecology reduced the fear of cancer recurrence significantly more than patient-initiated follow up, though the difference was small. Women who were instructed in alarm symptoms, under self-referral, were able to monitor their symptoms, and this approach significantly reduced the number of examinations at the department of gynaecology. What are the limitations of the work? Participants in the self-referral group knew that they were examined less than other women, and this may have induced fear of cancer recurrence. Similarly, the regular completion of questionnaires regarding fear of cancer recurrence may have reminded the women of the disease and diminished the difference between the two groups. What are the implications for patients Patient-initiated follow up reduced healthcare use but maintained fear of cancer recurrence in women who had survived early-stage endometrial cancer. Future analyses on quality of life and cost-effectiveness are needed to balance the benefits and harms of patient-initiated follow up.
验证患者主动随访是否能降低癌症复发恐惧（Fear of Cancer Recurrence，FCR）并减少医疗保健的使用，与传统的医院随访相比。
实用、多中心随机试验。
2013 年 5 月至 2016 年 5 月丹麦四个妇科部门。
156 名被诊断为国际妇产科联合会（FIGO）I 期低中级风险子宫内膜癌的女性。
对照组女性接受基于医院的随访，在初次治疗后 3 年内定期进行门诊随访。干预组女性接受患者主动随访的指导，包括仔细指导报警症状和自我转诊的选择，而不是按照检查时间表进行随访。
主要终点是在 10 个月的随访后，使用癌症复发恐惧量表（Fear of Cancer Recurrence Inventory，FCRI）测量的 FCR。次要终点包括治疗后 10 个月内与癌症相关的初级和二级卫生保健的使用。
在初步分析中，与对照组相比，控制组的 FCR 从基线显著降低（差异-5.9，95%CI-10.9 至-0.9）。这种改善的大部分发生在仅 3 个月的随访后。与对照组相比，接受干预的女性在部门接受的检查更少（0 次与中位数 2 次就诊，P<0.01），其中 58%的检查是由于阴道出血而安排的。
与患者主动随访相比，基于医院的随访显著更能减轻 FCR，尽管估计差异很小。患者主动随访是一种可行的、潜在降低成本的方法，适用于复发风险低的子宫内膜癌幸存者的随访。是否使用患者主动随访应权衡这些益处和危害。
患者主动随访可降低医疗保健的使用，但维持子宫内膜癌患者的癌症复发恐惧。
为什么和如何进行这项研究？对子宫内膜癌患者的随访是资源密集型的，先前的研究表明其效果不佳。尽管女性在随访中受益于安心，但常规检查也可能提醒女性疾病的存在，并引起对癌症复发的恐惧。此外，常规随访可能会延迟复发诊断，因为女性直到下一次预约就诊时才报告自己的症状。在本文中解释的研究中，患者主动随访被评估为替代传统随访的方法。女性被随机分配到两种随访方案之一：在妇科部门进行常规妇科检查或在接受仔细的报警症状指导下进行自我转诊，即患者主动随访。通过问卷获得两组的癌症复发恐惧水平。通过问卷和图表回顾获得医疗保健使用信息。研究的主要发现是什么？与患者主动随访相比，常规在妇科部门进行的检查显著降低了癌症复发恐惧，尽管差异很小。接受自我转诊和报警症状指导的女性能够监测自己的症状，这种方法显著减少了在妇科部门的检查次数。研究工作的局限性是什么？自我转诊组的参与者知道自己比其他女性接受的检查少，这可能会引起对癌症复发的恐惧。同样，定期完成关于癌症复发恐惧的问卷可能会提醒女性疾病的存在，并缩小两组之间的差异。对患者的意义是什么？患者主动随访减少了医疗保健的使用，但维持了早期子宫内膜癌幸存者的癌症复发恐惧。需要进一步分析质量和成本效益，以平衡患者主动随访的益处和危害。
