El-Jawahri Areej, Traeger Lara, Reese Jennifer B, Dizon Don, Bober Sharon L, Greer Joseph A, Vanderklish Julie, Horick Nora, Ufere Nneka, Reynolds Mathew J, Rice Julia, Clay Madison, Newcomb Richard, DeFilipp Zachariah, Chen Yi-Bin, Temel Jennifer S
Division of Hematology-Oncology, Massachusetts General Hospital Cancer Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Department of Psychology and Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA.
Lancet Haematol. 2025 Aug;12(8):e611-e620. doi: 10.1016/S2352-3026(25)00160-7.
Sexual dysfunction is a common complication affecting survivors of haematopoietic stem-cell transplantation (HSCT). Interventions to address sexual health in survivors of HSCT are limited. 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.
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. 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. The primary endpoint was to compare global satisfaction with sex scores (PROMIS sexual function and satisfaction measure) at 3 months between the study groups. We conducted analyses in accordance with the intention-to-treat principle. This study was registered with ClinicalTrials.gov (NCT03803696) and is complete.
Between Feb 15, 2019 and Feb 3, 2023, 125 (74%) of 169 eligible patients were enrolled to the study. 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. 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).
A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings underscore the potential of this intervention to be integrated into routine transplant care to improve sexual health outcomes for HSCT survivors.
American Cancer Society and the Leukemia & Lymphoma Society.
性功能障碍是造血干细胞移植（HSCT）幸存者中常见的并发症。针对HSCT幸存者性健康的干预措施有限。我们旨在评估一种多模式性功能障碍干预措施对改善HSCT幸存者性健康、生活质量（QOL）和心理结局的疗效。
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，采用多模式干预措施来解决HSCT幸存者的性功能障碍问题。参与者年龄在18岁及以上，患有血液系统恶性肿瘤，在研究入组前至少3个月接受了自体或异基因HSCT，根据美国国立综合癌症网络生存指南，性功能障碍筛查呈阳性且导致困扰。患者通过计算机生成的区组随机化方法被随机分配到干预组（参与者与一名经过培训的HSCT临床医生进行首次60分钟的就诊，随后每月进行两次30 - 45分钟的就诊，可亲自就诊、通过电话或安全视频平台）或强化常规护理（EUC）组，按移植类型和性别分层。主要终点是比较研究组在3个月时对性评分的总体满意度（患者报告结果测量信息系统性功能和满意度测量）。我们按照意向性分析原则进行分析。本研究已在ClinicalTrials.gov注册（NCT03803696）且已完成。
在2019年2月15日至2023年2月3日期间，169名符合条件的患者中有125名（74%）被纳入研究。纳入的患者大多为白人（125名中的107名[86%]）、非西班牙裔（113名[90%]）且为男性（84名[67%]），中位年龄为57.8岁（四分位间距46.5 - 65.8，范围20.3 - 81.9）。91名（73%）接受了异基因HSCT。在3个月时，随机分配到干预组的患者报告对性的总体满意度更高（基线时为11.5[标准差5.1]，3个月时为15.8[标准差5.3]），而EUC组从11.1[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]，科恩d值 = 0.85，p < 0.0001）。
由经过培训的HSCT临床医生提供的多模式干预措施使对性的总体满意度得到改善。这些发现强调了将这种干预措施纳入常规移植护理以改善HSCT幸存者性健康结局的潜力。
美国癌症协会和白血病与淋巴瘤协会。
