The menopause after cancer study (MACS) - A multimodal technology assisted intervention for the management of menopausal symptoms after cancer - Trial protocol of a phase II study

Fionán Donohoe, Yvonne O'Meara, Aidin Roberts, Louise Comerford, Catherine M Kelly, Janice M Walshe, Michelle Peate, Martha Hickey, Donal J Brennan, Fionán Donohoe, Yvonne O'Meara, Aidin Roberts, Louise Comerford, Catherine M Kelly, Janice M Walshe, Michelle Peate, Martha Hickey, Donal J Brennan

Abstract

Aims: This study will aim to assess if a composite intervention which involves a specific evidence-based intervention for management of insomnia and non-hormonal pharmacotherapy to manage vasomotor symptoms (VMS) of menopause can improve quality of life for patients experiencing troublesome VMS after cancer who are not eligible for standard systemic menopausal hormone therapy (MHT). Participants will be asked to nominate a partner or companion to support them during this process as an additional form of support.

Background: The menopause transition and its symptoms represent a significant challenge for many patients after cancer treatment, particularly those for whom conventional MHT is contraindicated. These symptoms include hot flushes, night sweats, urogenital symptoms as well as mood and sleep disturbance. These symptoms can exacerbate the consequences of cancer and its treatment.

Methods: We will recruit 205 women who meet inclusion criteria and enrol them on a composite intervention which consists of four parts: (1) use of non-hormonal pharmacotherapy for the management of troublesome vasomotor symptoms of menopause tailored to the timing of predominant symptoms, (2) digital cognitive behavioural therapy for insomnia through the web based Sleepio service, (3) access to information regarding self-management strategies for the common symptoms of menopause and their consequences and (4) identification of a partner or other support person who commits to providing support during the study period.

Outcomes: The primary outcome will be cancer specific quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). Secondary outcomes will include sleep quality, bother/interference of vasomotor symptoms and communication between couples about their cancer diagnosis and their menopause experience. Sleep will be measured using the Sleep Condition Indicator (SCI) tool, bother/interference of vasomotor symptoms will be measured by the Hot Flush Rating Scale (HFRS) and communication will be measured using the Couples' Illness Communication Scale (CICS). These validated scales will be administered at baseline, four weeks, three months and six months.

Registration: This study is registered on ClinicalTrials.gov with number NCT04766229.

Keywords: CBT; Cancer; Insomnia; Menopause symptoms; Quality of life; Survivorship.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2021 Published by Elsevier Inc.

Figures

Fig. 1
Fig. 1
Study overview.
Fig. 2
Fig. 2
Medication algorithm.

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