Background: Vasomotor symptoms (VMSs) associated with menopause represent a significant challenge for many patients after cancer treatment, particularly if conventional menopausal hormone therapy (MHT) is contraindicated. Methods: The Menopause after Cancer (MAC) Study (NCT04766229) was a single-arm phase II trial examining the impact of a composite intervention consisting of (1) the use of non-hormonal pharmacotherapy to manage VMS, (2) digital cognitive behavioral therapy for insomnia (dCBT-I) using Sleepio (Big Health), (3) self-management strategies for VMS delivered via the myPatientSpace mobile application and (4) nomination of an additional support person/partner on quality of life (QoL) in women with moderate-to-severe VMS after cancer. The primary outcome was a change in cancer-specific global QoL assessed by the EORTC QLC C-30 v3 at 6 months. Secondary outcomes included the frequency of VMS, the bother/interference of VMS and insomnia symptoms. Results: In total, 204 women (82% previous breast cancer) with a median age of 49 years (range 28–66) were recruited. A total of 120 women completed the protocol. Global QoL scores increased from 62.2 (95%CI 58.6–65.4) to 70.4 (95%CI 67.1–73.8) at 6 months (p< 0.001) in the intention to treatment (ITT) cohort (n= 204) and from 62 (95%CI 58.6–65.4) to 70.4 (95%CI 67.1–73.8) at 6 months (p< 0.001) in the per-protocol (PP) cohort (n= 120). At least 50% reductions were noticed in the frequency of VMS as well as the degree of bother/interference of VMS at six months. The prevalence of insomnia reduced from 93.1% at the baseline to 45.2% at 6 months (p< 0.001). The Sleep Condition Indicator increased from 8.5 (SEM 0.4) to 17.3 (SEM 0.5) (p< 0.0005) in the ITT cohort and 7.9 (SEM 0.4) to 17.3 (SEM 0.5) (p< 0.001) in the PP cohort. Conclusions: A targeted composite intervention improves the quality of life for cancer patients with frequent and bothersome vasomotor symptoms with additional benefits on frequency, the bother/interference of VMS and insomnia symptoms.
背景：癌症治疗后，与绝经相关的血管舒缩症状（VMS）对许多患者构成重大挑战，尤其是在传统绝经激素疗法（MHT）存在禁忌的情况下。方法：癌症后绝经（MAC）研究（NCT04766229）是一项单臂II期试验，旨在评估复合干预措施对癌症治疗后出现中重度VMS女性生活质量（QoL）的影响。该干预措施包括：（1）使用非激素药物治疗VMS；（2）通过Sleepio（Big Health）平台进行数字认知行为疗法治疗失眠（dCBT-I）；（3）通过myPatientSpace移动应用程序提供VMS自我管理策略；（4）指定额外支持人员/伴侣。主要结局指标为6个月时通过EORTC QLC C-30 v3量表评估的癌症特异性总体生活质量变化。次要结局包括VMS频率、VMS困扰/干扰程度及失眠症状。结果：共招募204名女性（82%曾患乳腺癌），中位年龄49岁（范围28-66岁）。其中120名女性完成研究方案。在意向治疗（ITT）队列（n=204）中，总体生活质量评分从62.2（95%CI 58.6-65.4）提升至6个月时的70.4（95%CI 67.1-73.8）（p<0.001）；在符合方案（PP）队列（n=120）中，评分从62（95%CI 58.6-65.4）提升至70.4（95%CI 67.1-73.8）（p<0.001）。6个月时，VMS频率及其困扰/干扰程度均出现至少50%的降低。失眠患病率从基线时的93.1%降至6个月时的45.2%（p<0.001）。睡眠状况指数量表评分在ITT队列中从8.5（SEM 0.4）升至17.3（SEM 0.5）（p<0.0005），在PP队列中从7.9（SEM 0.4）升至17.3（SEM 0.5）（p<0.001）。结论：针对性的复合干预措施可改善伴有频繁且困扰性血管舒缩症状的癌症患者的生活质量，并对降低VMS频率、减轻VMS困扰/干扰及改善失眠症状具有额外益处。
肿瘤(癌症)患者之家