Psychosexual Consequences of Risk-reducing Salpingo-oophorectomy

OBJECTIVES This study will evaluate the effectiveness of a mindfulness-based intervention in alleviating RRSO-induced menopausal complaints in BRCA1/2 mutation carriers. The intervention to be tested is MBSR training. The investigators hypothesize that women in the MBSR group will report statistically significantly greater improvement of menopause-specific quality of life from baseline to twelve weeks when compared to the control group and that this improvement will be maintained at six months and twelve months. The investigators also hypothesize that women in the MBSR group will report a statistically significantly greater improvement in sexual functioning and a decrease in sexual distress from baseline to twelve weeks when compared to the control group and that this improvement will be maintained at six and twelve months. The primary objective is to examine the effect of MBSR training on the menopause-specific quality of life in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints. The secondary objective is to examine the effect of MBSR training 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. STATISTICAL ANALYSIS The two treatment arms will be summarized at baseline with frequencies for categorical variables and means, ranges and SDs for continuous variables. Scores for the MenQOL, FSFI and FSDS will be calculated according to published scoring algorithms. A linear mixed effects analysis will be performed on the relationship between the MenQOL score and the intervention. The scores on the MenQOL at 12 weeks, 6 months and 12 months will be modelled as a function of treatment arm, time moment, their interaction. An unstructured correlation matrix will be assumed, unless the data indicate the presence of another correlation structure. If the groups are unbalanced, covariates will added to the model. All analysis will be conducted on an intention-to-treat basis. All analyses will be performed with SPSS. Similar analyses will be conducted for the FSFI and FSDS, which will be used as a secondary outcome measure.