The menopause after cancer study: A multimodal technology assisted intervention for the management of menopausal symptoms after cancer.
Authors: Donohoe Fionán , Roberts Aidín , O'Meara Yvonne , Comerford Louise , Kearns Una , Henry Alasdair , Higgins Michaela Jane , Walshe Janice Maria , Hickey Martha , Brennan Donal 
Published: June 2023

12024

Background: Vasomotor symptoms (VMS) of menopause represent a significant challenge for many patients after cancer treatment, particularly if 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 on quality of life (QoL) in women with moderate to severe VMS after cancer. The intervention consisted of: (1) use of non-hormonal pharmacotherapy to manage VMS (citalopram for predominantly daytime VMS and/or gabapentin for predominantly nocturnal VMS) (2) digital cognitive behavioural therapy for insomnia using Sleepio (BigHealth), (3) self-management strategies for VMS delivered via a mobile application called myPatientSpace and (4) nomination of an additional support person/partner. The primary outcome was cancer specific QoL assessed by the EORTC QLQ C30 version 3 at 6 months. Secondary outcomes included frequency of VMS, bother/interference of VMS (hot flush rating scale [HFRS]) and prevalence of insomnia (sleep condition indicator [SCI] ≥16) at 6 months. Results: 205 women (82% history of breast cancer) with a median age of 49 years (range 28-66) were recruited. Date of diagnosis ranged from January 2004 until January 2022, with 65% of participants diagnosed from 2019 onwards. Participants had a median of 10 hot flashes in a day (SD 9.2) and 4 night sweats each night (SD 4.9). 17.1% were prescribed citalopram, 62.8% gabapentin alone and 20.1% were prescribed both medications. 120 women completed the protocol. In the intention to treat (ITT) cohort (n = 205) mean QoL scores increased from 62.2 (SEM 1.4) at baseline to 70.4 (SEM 1.7) at 6 months (p < 0.001). In the per protocol (PP) cohort, (n = 120) mean QoL scores increased from 62 (SEM 1.7) to 70.4 (SEM 1.7) at 6 months (p < 0.001). Clinically meaningful improvements were seen across multiple domains of the EORTC QLQ C30 including cognitive function, emotional function and social functioning. Frequency of VMS decreased by 50% at 6 months in the ITT and PP cohorts. Mean HFRS scores decreased from 7.6 (SEM 0.1) to 3.4 (SEM 0.2) at 6 months (p < 0.0005) in the ITT cohort (7.5 (SEM 0.1) to 3.4 (SEM 0.2) (p < 0.001) in the PP cohort) demonstrating reduction in bother/interference of VMS. The prevalence of insomnia reduced from 92% at baseline to 38.7% at 6 months (p = 0.006) in the ITT cohort (95.2% to 38.7% in the PP cohort (p = 0.006)). Mean SCI scores increased from 8.5 (SEM 0.4) at baseline to 17.3 (SEM 0.5) at 6 months (p < 0.0005) in the ITT cohort (7.9 (SEM 0.4) to 17.3 (SEM 0.5) (p < 0.001) in the PP cohort). Significant reductions in wakefulness after sleep onset and sleep onset latency were major contributors to this improvement in insomnia symptoms. Conclusions: The MAC study demonstrates that improvements in QoL can be achieved using this multimodal intervention to target VMS and insomnia after cancer. Clinical trial information: NCT04766229 .