PURSUE - Psychosexual Consequences of Risk-reducing Salpingooophorectomy in BRCA1/2 Mutation Carriers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from baseline in the menopause-specific quality of life questionnaire (MENQOL) score.
研究概览
简要总结
Short Rationale: 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. Women who underwent RRSO experienced bothersome menopausal symptoms and worsening of sexual functioning related to acute surgical menopause. Hormone replacement therapy (HRT) will mitigate 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. 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.
Objective: 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.
Study population: Female BRCA1/2 mutation carriers who were younger than 52 years at the time of RRSO reporting two or more moderate to severe menopause related complaints after undergoing RRSO.
Study design: Prospective randomized controlled trial with a follow-up time of twelve months conducted at the University Medical Center Groningen (UMCG)
Intervention: Eight-week MBSR training consisting of a weekly class of two and half hours and a full retreat day. Furthermore participants are asked to practice mindfulness exercises at home for 45 minutes, six days a week.
Main study parameters/endpoints: Menopause specific quality of life score measured by the Menopause-specific quality of life questionnaire (MENQOL). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with taking part in a MBSR training or filling out the questionnaires that will be used in this study. The content of the questionnaires concerns intimate matters and could be considered burdensome. A possible benefit for the participants of the MBSR training is that participants will be more 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •younger than 52 years at the time of risk-reducing salpinghoophorectomy
- •no active cancer
排除标准
- •severe cognitive or psychiatric problems
- •no sufficient mastery of the Dutch language
研究组 & 干预措施
Mindfullness based stress reduction
干预措施: Mindfulness based stress reduction (MBSR) (Behavioral)
Care as usual
All participants in the intervention and control group receive the care as usual. The care as usual consists of a clinic appointment with the research nurse. In this appointment the RRSO-induced menopausal complaints will be discussed in more detail. Depending on the complaints at hand, information, reassurance and life style advice will be offered. A leaflet with relevant information will be provided for. Furthermore, the usual medical care may include prescription of (non-)hormonal medicationsTwelve weeks after the clinic appointment, the research nurse will contact all participants per telephone to ask whether there are issues that remain to be addressed.
Participants are allowed to continue the use of all their current medication.
结局指标
主要结局
Change from baseline in the menopause-specific quality of life questionnaire (MENQOL) score.
时间窗: Baseline, 12 weeks, 6 and 12 months
The MENQOL is a self-administered 29-item questionnaire developed to assess quality of life in menopausal women. It not only records menopausal symptoms, but also the degree of bother women experience due to the menopausal symptoms. It consists of four domains: vasomotor (three items), psychosocial (seven items), physical (sixteen items) and sexual (three items). All items firstly ask whether or not a woman has experienced the item in the prior four weeks. If this was the case she is then asked to indicate how much she was bothered on a zero (no bother) to seven (extreme bother) scale. Higher scores on the MENQOL reflect a poorer menopause-specific quality of life. The minimal clinically important difference was found to be 1.0. The MENQOL is available in Dutch and has undergone extensive linguistic validation.
次要结局
- Change from baseline in the female sexual function index questionnaire (FSFI) score.(Baseline, 12 weeks, 6 and 12 months)
- Change from baseline in the female sexual distress scale (FSDS) score.(Baseline, 12 weeks, 6 and 12 months)
研究者
Catheleine van Driel
MD/PhD candidate
University Medical Center Groningen