The menopause after cancer study: A multimodal technology assisted intervention for the management of menopausal symptoms after cancer.

person Fionán Donohoe UCD Gynaecological Oncology Group, Dublin, Ireland info_outline Fionán Donohoe, Aidín Roberts, Yvonne O'Meara, Louise Comerford, Una Kearns, Alasdair Henry, Michaela Jane Higgins, Janice Maria Walshe, Martha Hickey, Donal Brennan

Authors person Fionán Donohoe UCD Gynaecological Oncology Group, Dublin, Ireland info_outline Fionán Donohoe, Aidín Roberts, Yvonne O'Meara, Louise Comerford, Una Kearns, Alasdair Henry, Michaela Jane Higgins, Janice Maria Walshe, Martha Hickey, Donal Brennan Organizations UCD Gynaecological Oncology Group, Dublin, Ireland, myPatientSpace, Dublin, Ireland, Big Health, Glasgow, United Kingdom, St. Vincent University Hospital, Dublin, Ireland, St. Vincent's University Hospital, Dublin, Ireland, Royal Women's Hospital/University of Melbourne, Melbourne, Australia Abstract Disclosures Research Funding Other Foundation Irish Cancer Society 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.

Clinical