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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Sep 18, 2020
Date Accepted: Nov 17, 2020

The final, peer-reviewed published version of this preprint can be found here:

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 L, Hooning MJ, Heemskerk-Gerritsen BAM, van Beurden M, Roeters van Lennep JE, van Doorn HC, de Hullu JA, Mom C, van Dorst EBL, Mourits MJE, Slangen BFM, Gaarenstroom KN, Zillikens C, Leiner T, van der Kolk L, Collee M, Wevers M, Ausems MG, van Engelen K, Berger LP, van Asperen CJ, Gomez Garcia EB, van de Beek I, Rookus MA, Hauptmann M, Bleiker EM, Schagen SB, Aaronson NK, Maas AH, van Leeuwen FE

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)

JMIR Res Protoc 2021;10(1):e24414

DOI: 10.2196/24414

PMID: 33480862

PMCID: 7864779

Long-term morbidity and health after early menopause due to oophorectomy in women at increased risk of ovarian cancer: rationale and design of the HARMOny study, a nationwide cross-sectional study with prospective follow-up.

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

ABSTRACT

Background:

BRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35-45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about 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.

Objective:

The aim of this study is to assess long-term health effects of premenopausal RRSO in women with high familial risk of breast and/or ovarian cancer on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning and HRQOL.

Methods:

We will conduct a multicenter, cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at familial risk of breast and/or ovarian cancer. Five-hundred women who underwent RRSO before 45 years of age, with ≥10 years of follow-up after RRSO, will be compared with 250 women (frequency-matched on current age) who had no RRSO, or who were older than 55 years when they underwent an RRSO. 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.

Results:

This study was approved by the IRB in July 2018. In February 2019 we included our first participant. At submission of the manuscript we had included 300 participants.

Conclusions:

Knowledge from this study will contribute importantly to counselling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. Results can also be used to offer health recommendations after RRSO. Clinical Trial: ClinicalTrials.gov: NCT03835793


 Citation

Please cite as:

Terra L, Hooning MJ, Heemskerk-Gerritsen BAM, van Beurden M, Roeters van Lennep JE, van Doorn HC, de Hullu JA, Mom C, van Dorst EBL, Mourits MJE, Slangen BFM, Gaarenstroom KN, Zillikens C, Leiner T, van der Kolk L, Collee M, Wevers M, Ausems MG, van Engelen K, Berger LP, van Asperen CJ, Gomez Garcia EB, van de Beek I, Rookus MA, Hauptmann M, Bleiker EM, Schagen SB, Aaronson NK, Maas AH, van Leeuwen FE

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)

JMIR Res Protoc 2021;10(1):e24414

DOI: 10.2196/24414

PMID: 33480862

PMCID: 7864779

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