Department of Gynaecology, Leiden University Medical Center, Zone K6-T, PO Box 9600, 2300 RC, Leiden, the Netherlands.
Department of Radiotherapy, Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.
BMC Cancer. 2021 Dec 4;21(1):1295. doi: 10.1186/s12885-021-08991-2.
Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy (EBRT+BT). Studies demonstrate that psychosexual support should include cognitive behavioural interventions and involvement of the patient's partner, if available. Therefore, we developed a nurse-led sexual rehabilitation intervention, including these key components. The intervention was previously pilot-tested and results demonstrated that this intervention improves women's sexual functioning and increases dilator compliance. The objective of the current study is to investigate the (cost-)effectiveness of the intervention compared to optimal care as usual (CAU). We expect that women who receive the intervention will report a statistically significant greater improvement in sexual functioning and - for women who receive EBRT+BT - higher compliance with dilator use, from baseline to 12 months post-RT than women who receive optimal care as usual (CAU).
METHODS/DESIGN: The intervention is evaluated in the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre, randomized controlled trial (RCT). The primary endpoint is sexual functioning. Secondary outcomes include body image, fear of sexual activity, sexual-, treatment-related- and psychological distress, health-related quality of life and relationship satisfaction. A cost-effectiveness analysis (CEA) will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. The study sample will consist of 220 women with GC treated with RT in specialized GC treatment centres (N = 10). Participants are randomized to either the intervention- or CAU control group (1:1), and within each centre stratified by type of radiotherapy (EBRT+BT vs. EBRT only) and having a partner (yes/no). All women complete questionnaires at baseline (T1) and at 1, 3, 6, and 12 months post-RT (T2, T3, T4 and T5, respectively).
There is a need to improve sexual functioning after RT for GC. This RCT will provide evidence about the (cost-)effectiveness of a nurse-led sexual rehabilitation intervention. If proven effective, the intervention will be a much needed addition to care offered to GC survivors and will result in improved quality of life.
ClinicalTrials.gov, NCT03611517 . Registered 2 August 2018.
妇科癌症（GC）患者在接受放射治疗（RT）后常报告出现性问题，尤其是在接受外照射放疗联合近距离放疗（EBRT+BT）后。研究表明，性心理支持应包括认知行为干预，并在可能的情况下让患者的伴侣参与。因此，我们开发了一种由护士主导的性康复干预措施，其中包括这些关键组成部分。该干预措施此前已进行了试点测试，结果表明，该干预措施可改善女性的性功能，并提高扩张器的依从性。本研究的目的是调查该干预措施与常规最佳护理（CAU）相比的（成本）效果。我们预计，与接受常规最佳护理（CAU）的女性相比，接受该干预措施的女性在接受 RT 后 12 个月内，性功能会有统计学上的显著改善，对于接受 EBRT+BT 的女性，扩张器使用的依从性也会更高。
方法/设计：该干预措施在 SPARC（妇科癌症放疗后性康复计划）研究中进行评估，这是一项多中心、随机对照试验（RCT）。主要终点是性功能。次要结局包括身体形象、对性活动的恐惧、与性相关的、与治疗相关的和心理困扰、健康相关的生活质量和关系满意度。将进行成本效果分析（CEA），其中将干预措施的成本与其他医疗保健成本的变化以及对患者结果的影响联系起来。研究样本将包括 220 名在专门的 GC 治疗中心接受 RT 治疗的 GC 女性（N=10）。参与者随机分配到干预组或常规最佳护理（CAU）对照组（1:1），并在每个中心内按放疗类型（EBRT+BT 与 EBRT 单独）和是否有伴侣（是/否）进行分层。所有女性在基线（T1）和接受 RT 后 1、3、6 和 12 个月（T2、T3、T4 和 T5）时分别完成问卷。
需要改善 GC 患者接受 RT 后的性功能。这项 RCT 将提供关于护士主导的性康复干预措施的（成本）效果的证据。如果证明有效，该干预措施将是 GC 幸存者护理的一个非常需要的补充，将提高生活质量。
ClinicalTrials.gov，NCT03611517。于 2018 年 8 月 2 日注册。
