Primary objective The primary objective is to examine the effect of a MBSR intervention on the menopause-specific quality of life in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints. Secondary objectiveThe secondary…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing ovarian
cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective
in detecting ovarian cancer in an early and curable stage. Although RRSO is
very effective in decreasing the risk of developing ovarian cancer, women who
underwent RRSO experienced bothersome menopausal symptoms and worsening of
sexual functioning related to acute surgical menopause. Hormone replacement
therapy (HRT) will mitigated some of the RRSO-induced menopausal complaints,
however it does not reduce the complaints to a premenopausal level, and the
sexual symptoms are not alleviated. Furthermore in BRCA1/2 mutation carriers a
personal history of breast cancer is prevalent which contraindicates the use of
HRT. As a possible alternative to HRT, Mindfulness interventions were found to
improve sexual functioning and alleviate menopausal symptoms in various
populations. It has not been investigated whether mindfulness-based stress
reduction (MBSR) is effective in mitigating the RRSO-induced menopausal
complaints in BRCA1/2 mutation carriers and if this effect is sustained over a
longer period of time.
Study objective
Primary objective
The primary objective is to examine the effect of a MBSR intervention on the
menopause-specific quality of life in BRCA1/2 mutation carriers who experience
RRSO-induced menopausal complaints.
Secondary objective
The secondary objective is to examine the effect of a MBSR intervention on
sexual functioning and distress in BRCA1/2 mutation carriers who experience
RRSO-induced menopausal complaints.
Study design
The study is a prospective, randomized controlled trial, with an intervention
group that receives an eight-week MBSR training as well as care as usual and a
control group that only receives care as usual. All participants will be asked
to fill out questionnaires regarding menopausal and sexual complaints at
baseline before randomization (T0) and at twelve weeks (T1), six (T2) and
twelve months (T3) after randomization. The study will be conducted at the
family cancer clinic of the UMCG.
Intervention
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 delivered by certified
trainers. This program aims to train paying full attention to the present
moment in a non-judgemental way trough exercises as meditation, yoga and body
scans.
The control group does not take this training. Both groups receive care as
usual (see protocol, paragraph 5.2 care as usual).
Study burden and risks
There are no risks associated with taking part in a MBSR intervention or
filling in the questionnaires that will be used in this study. The content of
the questionnaires concerns intimate matters and could be considered
burdensome. A benefit for the participants of the MBSR intervention could be
that they will be better able to cope with their complaints after RRSO. The
group relatedness is reflected in the fact that RRSO is specifically performed
in women with a hereditary risk of ovarian cancer such as BRCA1/2 mutation
carriers.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46796.042.14 |