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  • What Happens After Menopause? (WHAM): protocol for a prospective, multicentre, age-matched cohort trial of risk-reducing bilateral salpingo-oophorectomy in high-risk premenopausal women

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Obstetrics and gynaecology
Protocol
What Happens After Menopause? (WHAM): protocol for a prospective, multicentre, age-matched cohort trial of risk-reducing bilateral salpingo-oophorectomy in high-risk premenopausal women
  1. Martha Hickey1,
  2. Alison Trainer2,3,
  3. Sabine Braat4,
  4. Mary-Ann Davey5,
  5. Efrosinia Krejany6,
  6. John Wark2,7
  1. 1 Department of Obstetrics and Gynaecology, The Royal Women’s Hospital, University of Melbourne, Melbourne, Victoria, Australia
  2. 2 Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
  3. 3 Parkville Familial Cancer Centre, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  4. 4 Melbourne Clinical and Translational Sciences (MCATS), Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  5. 5 Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia
  6. 6 Gynaecology Research Centre, The Royal Women’s Hospital, Parkville, Victoria, Australia
  7. 7 Department of Bone and Mineral Medicine, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Martha Hickey; hickeym{at}unimelb.edu.au

Abstract

Introduction Women at high inherited risk of ovarian cancer are advised to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) at age 40–45 years or when their families are complete. Most women are premenopausal at this age, so RRBSO will induce surgical menopause. Despite the clear benefits of RRBSO for cancer risk reduction, much less is known about the impact on non-cancer outcomes that contribute to health and well-being and inform surveillance and management strategies.

Methods and analysis This will be a multicentre, prospective cohort study of 105 premenopausal high-risk women undergoing RRBSO and an age-matched comparison group of 105 premenopausal women not planning oophorectomy or pregnancy in the next 2 years. The aim of this study is to measure the impact of RRBSO on sexual function (primary outcome) at 24 months in high-risk premenopausal women compared with the comparison group. Secondary outcomes include menopausal symptoms and menopause-related quality of life, mood, sleep quality, markers of cardiovascular disease and pre-diabetes, bone density and markers of bone turnover, and the impact of hormone replacement therapy use on these outcomes. Data analysis methods will include logistic and linear regression using general estimating equations accounting for the repeated outcome measurements within each participant.

Ethics and dissemination The study has been approved by institutional ethics committees at each participating centre. Findings will be disseminated through peer-reviewed publications and conference presentations, and national and international networks of centres managing high-risk women, and will inform national and international clinical guidelines.

Trial registration number The pre-results protocol for this trial is registered with the Australian New Zealand Clinical Trials Registry (anzctr.org.au; registration no: ACTRN12615000082505).

  • menopause
  • ovarian cancer
  • RRBSO

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-018758

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    Footnotes

    • Contributors MH, AT, SB, M-AD, EOK and JW contributed to the conception, design, writing and editing of the protocol. MH drafted the manuscript, and all other authors contributed to the final version. SB wrote the statistical methods. MH is the guarantor. All authors read and approved the final manuscript.

    • Funding The study is supported by an NHMRC Project Grant (APP1048023) and by the Australia and New Zealand Gynaecological Oncology Group. MH is supported by an NHMRC Practitioner Fellowship (APP1058935).

    • Competing interests None declared.

    • Patient consent We are using Peter MacCallum Cancer Centre HREC approved consent forms.

    • Ethics approval The study has been granted ethics approval at each of the participating recruitment centres, including the following: Peter MacCallum Cancer Centre (Victoria, Australia), HREC/12/PMCC/24, 12/90, 04/12/2012; The Royal Women’s Hospital (Victoria, Australia), HREC/12/PMCC/24, 12/07, 20/12/2012; The Royal Melbourne Hospital (Victoria, Australia), HREC/12/PMCC/24, 2013/060, 07/10/2013; Prince of Wales Hospital) (New South Wales, Australia), HREC/13/POWH/61, 12/304, 23/05/2013; Westmead Hospital (New South Wales, Australia), HREC/13/POWH/61, SSA/13/WMEAD/189, 28/11/2013; Royal Hospital for Women (New South Wales, Australia), HREC/13/POWH/61, 14/G/146, 29/04/2014; Royal Prince Alfred Hospital (New South Wales, Australia), X14-0396, 10/21, 22/04/2015; and Chris O’Brien Lifehouse (New South Wales, Australia), X14-0396, LH15/035, 10/08/2015.

    • Provenance and peer review Not commissioned; externally peer reviewed.