A multimodal sexual dysfunction intervention versus enhanced usual care for survivors of haematopoietic stem-cell transplantation: a single-centre, open-label, randomised clinical trial.

Interventions to address sexual health in survivors of HSCT are limited.

针对HSCT幸存者性健康的干预措施有限。

We aimed to assess the efficacy of a multimodal sexual dysfunction intervention for improving sexual health, quality of life (QOL), and psychological outcomes in survivors of HSCT.

我们旨在评估一种多模式性功能障碍干预措施对于改善造血干细胞移植（HSCT）幸存者的性健康、生活质量（QOL）和心理结果的有效性。

Methods

We conducted a single-centre, open-label, randomised clinical trial of a multimodal intervention to address sexual dysfunction in survivors of HSCT at Massachusetts General Hospital. Participants were aged 18 years or older, had a haematological malignancy, and had undergone autologous or allogeneic HSCT at least 3 months before study enrolment, with a positive screening for sexual dysfunction causing distress according to the National Comprehensive Cancer Network survival guidelines.

我们在马萨诸塞州总医院进行了一项单中心、开放标签、随机临床试验，以解决造血干细胞移植（HSCT）幸存者的性功能障碍问题。参与者年龄在18岁或以上，患有血液恶性肿瘤，并在研究登记前至少3个月接受过自体或异基因HSCT，根据国家综合癌症网络生存指南，性功能障碍筛查结果为阳性，导致困扰。

Patients were randomly assigned to the intervention (participants met with a trained HSCT clinician for an initial 60 mins visit, followed by two 30-45 mins monthly visits, either in person, by telephone, or over a secure video platform) or enhanced usual care (EUC) using computer-generated block randomisation, stratified by transplantation type and sex.

患者被随机分配到干预组（参与者与受过培训的造血干细胞移植（HSCT）临床医生进行初次60分钟的访问，随后进行两次30-45分钟的月度访问，可以通过面对面、电话或安全视频平台进行）或增强常规护理（EUC），使用计算机生成的分块随机化，按移植类型和性别进行分层。

The primary endpoint was to compare global satisfaction with sex scores (PROMIS sexual function and satisfaction measure) at 3 months between the study groups.

主要终点是比较3个月时两组患者对性满意度的全球评分（PROMIS性功能和满意度测量）的差异。

We conducted analyses in accordance with the intention-to-treatprinciple.

我们的分析是根据意向治疗原则进行的。

This study was registered with ClinicalTrials.gov (NCT03803696) and is complete.

这项研究已在ClinicalTrials.gov上注册（NCT03803696），研究已完成。

Results

Between Feb 15, 2019 and Feb 3, 2023, 125 (74%) of 169 eligible patients were enrolled to the study.

在2019年2月15日至2023年2月3日期间，共有125名（占74%）符合条件的169名患者被纳入研究。

Enrolled patients were mostly White (107 [86%] of 125), non-Hispanic (113 [90%]), and male (84 [67%]), and had a median age of 57·8 years (IQR 46·5-65·8, range 20·3-81·9). 91 (73%) had received an allogeneic HSCT.

纳入的患者大多数为白人（125名中的107名，占86%）、非西班牙裔（125名中的113名，占90%）和男性（125名中的84名，占67%），中位年龄为57.8岁（四分位数间距46.5-65.8岁，年龄范围20.3-81.9岁）。有91名患者（占73%）接受了异基因造血干细胞移植（HSCT）。

At 3 months, patients randomised to the intervention reported better global satisfaction with sex (11·5 [SD 5·1] at baseline to 15·8 [SD 5·3] at 3 months) compared to EUC (from 11·1 [4·5] to 11·2 [SD 5·1]; mean difference 4·7 [95% CI 3·0-6·3], Cohen's d=0·85, p<0·0001).

在3个月时，被随机分配到干预组的患者报告了更好的性满意度（基线时为11·5 [标准差 5·1]，3个月时为15·8 [标准差 5·3]），与EUC相比（从11·1 [标准差 4·5] 到11·2 [标准差 5·1]；平均差异为4·7 [95% 置信区间 3·0-6·3]，Cohen's d=0·85，p<0·0001）。

interpretation

A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex.

由训练有素的造血干细胞移植（HSCT）临床医生实施的多模式干预措施，导致了性满意度的整体改善。

These findings underscore the potential of this intervention to be integrated into routine transplant care to improve sexual health outcomes for HSCT survivors.

这些发现强调了将此干预措施纳入常规移植护理中以改善造血干细胞移植（HSCT）幸存者的性健康结果的潜力。

funding

American Cancer Society and the Leukemia & Lymphoma Society.

美国癌症协会和白血病与淋巴瘤协会。