JMIR Research Protocols (Jan 2021)

Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer: Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study)

  • Terra, Lara,
  • Hooning, Maartje J,
  • Heemskerk-Gerritsen, Bernadette A M,
  • van Beurden, Marc,
  • Roeters van Lennep, Jeanine E,
  • van Doorn, Helena C,
  • de Hullu, Joanne A,
  • Mom, Constantijne,
  • van Dorst, Eleonora B L,
  • Mourits, Marian J E,
  • Slangen, Brigitte F M,
  • Gaarenstroom, Katja N,
  • Zillikens, M Carola,
  • Leiner, Tim,
  • van der Kolk, Lizet,
  • Collee, Margriet,
  • Wevers, Marijke,
  • Ausems, Margreet G E M,
  • van Engelen, Klaartje,
  • Berger, Lieke PV,
  • van Asperen, Christi J,
  • Gomez-Garcia, Encarna B,
  • van de Beek, Irma,
  • Rookus, Matti A,
  • Hauptmann, Michael,
  • Bleiker, Eveline M,
  • Schagen, Sanne B,
  • Aaronson, Neil K,
  • Maas, Angela H E M,
  • van Leeuwen, Flora E

DOI
https://doi.org/10.2196/24414
Journal volume & issue
Vol. 10, no. 1
p. e24414

Abstract

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BackgroundBRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35 to 45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about the potential adverse effects of premenopausal RRSO, such as increased risk of cardiovascular disease, osteoporosis, cognitive dysfunction, and reduced health-related quality of life (HRQoL), is limited. ObjectiveThe aim of this study is to assess the long-term health effects of premenopausal RRSO on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning, and HRQoL in women with high familial risk of breast or ovarian cancer. MethodsWe will conduct a multicenter cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at high familial risk of breast or ovarian cancer. A total of 500 women who have undergone RRSO before 45 years of age, with a follow-up period of at least 10 years, will be compared with 250 women (frequency matched on current age) who have not undergone RRSO or who have undergone RRSO at over 55 years of age. Participants will complete an online questionnaire on lifestyle, medical history, cardiovascular risk factors, osteoporosis, cognitive function, urological complaints, and HRQoL. A full cardiovascular assessment and assessment of bone mineral density will be performed. Blood samples will be obtained for marker analysis. Cognitive functioning will be assessed objectively with an online neuropsychological test battery. ResultsThis study was approved by the institutional review board in July 2018. In February 2019, we included our first participant. As of November 2020, we had enrolled 364 participants in our study. ConclusionsKnowledge from this study will contribute to counseling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. The results can also be used to offer health recommendations after RRSO. Trial RegistrationClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793. International Registered Report Identifier (IRRID)DERR1-10.2196/24414