Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life-Results from the Menopause after Cancer (Mac) Study

Fionán Donohoe; Yvonne O'Meara; Aidin Roberts; Louise Comerford; Ivaila Valcheva; Una Kearns; Marie Galligan; Michaela J Higgins; Alasdair L Henry; Catherine M Kelly; Janice M Walshe; Martha Hickey; Donal J Brennan

doi:10.3390/cancers16061127

Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life-Results from the Menopause after Cancer (Mac) Study

Cancers (Basel). 2024 Mar 12;16(6):1127. doi: 10.3390/cancers16061127.

Authors

Affiliations

¹ UCD Gynaecological Oncology Group, UCD School of Medicine, Mater Misericordiae University Hospital, Eccles Street, D07 AX57 Dublin, Ireland.
² myPatientSpace Ltd., K36 A022 Dublin, Ireland.
³ Clinical Research Centre, UCD School of Medicine, Mater Misericordiae University Hospital, Eccles Street, D07 AX57 Dublin, Ireland.
⁴ Department of Medical Oncology, St. Vincent's University Hospital, Elm Park, D04 T6F4 Dublin, Ireland.
⁵ Big Health Ltd., London WC1H 9LT, UK.
⁶ Big Health Ltd., San Francisco, CA 94108, USA.
⁷ Department of Medical Oncology, Mater Misericordiae University Hospital, Eccles Street, D07 AX57 Dublin, Ireland.
⁸ Department of Obstetrics and Gynaecology, University of Melbourne and The Royal Women's Hospital, Parkville, VIC 3052, Australia.
⁹ Systems Biology Ireland, UCD School of Medicine, Belfield, D04 V1W8 Dublin, Ireland.

Abstract

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.

Keywords: insomnia; menopause; quality of life; survivorship.

Grants and funding

WHIBRE20/Irish Cancer Society