Gynaecological Cancer Centre, University College London Hospitals, London, UK.
PRIMENT Clinical Trials Unit, University College London, London, UK.
Health Technol Assess. 2019 Feb;23(6):1-92. doi: 10.3310/hta23060.
Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a 'stepped care' model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin.
Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions.
A feasibility two-arm, parallel-group randomised controlled pilot trial.
Two NHS gynaecological cancer centres, one in London and one in Bristol.
A three-level stepped care intervention.
To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally.
Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial.
Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined.
None, as the study was halted.
The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial.
Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001.
This project was funded by the NIHR HTA programme and will be published in full in ; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.
受妇科癌症影响的女性通常不知道癌症及其治疗对性的影响。大多数人没有得到适当的建议或帮助来恢复性功能，这可能会对她们的性产生深远的影响，包括身体和情感方面。然而，几种潜在的疗法可以有效地帮助恢复一些性行为并改变对性的自我认知。一个主要的初始挑战是以适当和敏感的方式告知和参与患者，另一个问题是在繁忙的妇科肿瘤诊所中提供治疗。本研究是对国家卫生研究院（NIH）健康技术评估（HTA）的一项呼吁的回应，该呼吁要求提出建议，以改善接受妇科癌症治疗的女性的性功能，同时考虑到与情绪相关的问题。现有的循证疗法已被改编，并纳入 NHS 环境中提供这些疗法的“阶梯式护理”模型。同时开发了评估和治疗阶梯算法，以便在评估时为女性分配治疗水平，并在每次治疗时跟踪她们的进展，以建议改变干预水平。评估工具适用于所有参与者，其原则是存在性困难问题，而不是癌症起源问题。
年龄大于 18 岁（有伴侣选择）的女性，因任何妇科恶性肿瘤接受手术和/或化疗和/或放射治疗，在伦敦大学学院医院或布里斯托尔妇科癌症中心至少 3 个月后结束治疗，任何性取向，通过三个初始筛选问题确定性功能困难。
一项可行性、两臂、平行组随机对照试点试验。
两个 NHS 妇科癌症中心，一个在伦敦，一个在布里斯托尔。
三级阶梯式护理干预。
评估阶梯治疗的全面研究的可行性，并指出对患者和 NHS 整体的潜在益处。
研究的招募情况、女性升级比例、所有措施和试验期间所有时间点的可用数据点数量，以及参与者的保留率到试验结束。
干预措施及其伴随算法的开发已经完成。在招募阶段之前，该研究被停止，因此没有进行随机化、招募、分析数量、结果或危害记录。
由于研究未进行，干预措施及其伴随算法尚未在实践中进行评估，也没有检查 NHS 系统提供干预措施的能力。
由于研究停止，因此没有。
该干预措施可以在临床环境中进行研究；然而，研究小组的经验表明，需要在医疗环境中进行社会心理研究，以建立务实和创新的机制，以确保在试验期间为员工的临床技能和时间提供足够的资源，以提供任何新的干预措施。
当前对照试验 ISRCTN8035151 和 ClinicalTrials.gov NCT02458001。
该项目由 NIH HTA 计划资助，将在 中全文发表；第 23 卷，第 5 期。有关该项目的更多信息，请访问 NIH 期刊图书馆网站。
