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Psychosexual consequences of risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers.

Psychosexual consequences of risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers. - PURSUE:Psychosexual consequences of risk-reducing salpingo-oophorectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40602
Enrollment
124
Registered
2014-11-14
Start date
2015-01-05
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menopausal transition. Menopause

Interventions

eight week MBSR training consisting of a weekly class of two and a half hours and an eight hour training day. MBSR is a standardized psychosocial intervention developed by Dr. Jon Kabat-Zinn and is

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All women who underwent risk-reducing salpingo-oophorectmy (RRSO) at the UMCG and who were younger than 52 years at the time of RRSO, have no active cancer at the time of inclusion and report two or more moderate to severe menopause related complaints (see researchprotocol, paragraph 4.2).

Exclusion criteria

Exclusion criteria: Women will be excluded from the study if they have no sufficient mastery of the Dutch language, if they suffer from severe cognitive or psychiatric problems.

Design outcomes

Primary

MeasureTime frame
As the primary parameter, the MENQOL will be used to assess menopause-specific quality of life in the MBSR and control group at baseline to twelve weeks.

Secondary

MeasureTime frame
As the secondary parameters, the MENQOL will be used to assess menopause-specific quality of life in the MBSR and control group at baseline to six and twelve months. Furthermore as secondary parameters the female sexual function index questionnaire (FSFI) and female sexual distress scale questionnaire (FSDS) will be used to assess sexual functioning and sexual distress in the MBSR and control group at baseline to twelve weeks, six months and twelve months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)