Psychosexual Consequences of Risk-reducing Salpingo-oophorectomy

NCT02372864 | Completed DMC

• 1 other identifier: PURSUE2014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

Ovariectomy; Mindfulness; Postmenopause; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the menopause-specific quality of life questionnaire (MENQOL) score.

  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.

  Baseline, 12 weeks, 6 and 12 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Care as usual

NO INTERVENTION

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.

Mindfullness based stress reduction

EXPERIMENTAL

Behavioral: Mindfulness based stress reduction (MBSR)

Interventions

Mindfulness based stress reduction (MBSR) BEHAVIORAL

Mindfulness based stress reduction (MBSR) is a standardized eight-week psychosocial intervention delivered by certified trainers. The programme consists of a weekly class of two and half hours for a period of eight weeks and a full retreat day. Furthermore participants are asked to practice exercises at home for 45 minutes, six days a week. The MBSR class will consist of ten to twelve persons, starting at different weekdays and moments of the day. If during the inclusion process it becomes apparent that a group of participants (provided a sufficient group size) comes from a region (e.g. Friesland or Overijssel) with a considerable amount of traveling time to the UMCG, efforts will be made to start a MBSR training in the region with trainers from the UMCG.

Mindfullness based stress reduction

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• younger than 52 years at the time of risk-reducing salpinghoophorectomy
• no active cancer

You may not qualify if:

• severe cognitive or psychiatric problems
• no sufficient mastery of the Dutch language

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Centre Groningen

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Hot Flashes

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marian JE Mourits, prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/PhD candidate

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

NL (1)