Donohoe Fionán, O'Meara Yvonne, Roberts Aidin, Comerford Louise, Valcheva Ivaila, Kearns Una, Galligan Marie, Higgins Michaela J, Henry Alasdair L, Kelly Catherine M, Walshe Janice M, Hickey Martha, Brennan Donal J
UCD Gynaecological Oncology Group, UCD School of Medicine, Mater Misericordiae University Hospital, Eccles Street, D07 AX57 Dublin, Ireland.
myPatientSpace Ltd., K36 A022 Dublin, Ireland.
Cancers (Basel). 2024 Mar 12;16(6):1127. doi: 10.3390/cancers16061127.
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.
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.
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 ( < 0.001) in the intention to treatment (ITT) cohort ( = 204) and from 62 (95%CI 58.6-65.4) to 70.4 (95%CI 67.1-73.8) at 6 months ( < 0.001) in the per-protocol (PP) cohort ( = 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 ( < 0.001). The Sleep Condition Indicator increased from 8.5 (SEM 0.4) to 17.3 (SEM 0.5) ( < 0.0005) in the ITT cohort and 7.9 (SEM 0.4) to 17.3 (SEM 0.5) ( < 0.001) in the PP cohort.
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.
与更年期相关的血管舒缩症状（VMS）对许多癌症治疗后的患者构成了重大挑战，尤其是在传统的更年期激素疗法（MHT）存在禁忌的情况下。
癌症后更年期（MAC）研究（NCT04766229）是一项单臂II期试验，旨在研究一种综合干预措施的影响，该措施包括：（1）使用非激素药物疗法来管理VMS；（2）使用Sleepio（Big Health）进行针对失眠的数字认知行为疗法（dCBT-I）；（3）通过myPatientSpace移动应用程序提供的VMS自我管理策略；（4）指定一名额外的支持人员/伴侣对癌症后患有中度至重度VMS的女性的生活质量（QoL）的影响。主要结局是在6个月时通过欧洲癌症研究与治疗组织（EORTC）QLC C-30 v3评估的癌症特异性总体生活质量的变化。次要结局包括VMS的频率、VMS和失眠症状的困扰/干扰程度。
总共招募了204名女性（82%曾患乳腺癌），中位年龄为49岁（范围28 - 66岁）。共有120名女性完成了方案。在意向性治疗（ITT）队列（n = 204）中，总体生活质量评分在6个月时从62.2（95%CI 58.6 - 65.4）提高到70.4（95%CI 67.1 - 73.8）（P < 0.001），在符合方案（PP）队列（n = 120）中，6个月时从62（95%CI 58.6 - 65.4）提高到70.4（95%CI 67.1 - 73.8）（P < 0.001）。在6个月时，VMS的频率以及VMS的困扰/干扰程度至少降低了50%。失眠的患病率从基线时的93.1%降至6个月时的45.2%（P < 0.001）。在ITT队列中，睡眠状况指标从8.5（标准误0.4）提高到17.3（标准误0.5）（P < 0.0005），在PP队列中从7.9（标准误0.4）提高到17.3（标准误0.5）（P < 0.001）。
一种有针对性的综合干预措施可改善患有频繁且烦人的血管舒缩症状的癌症患者的生活质量，对VMS的频率、困扰/干扰程度以及失眠症状还有额外益处。
