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Trial registered on ANZCTR


Registration number
ACTRN12615000207516
Ethics application status
Approved
Date submitted
14/02/2015
Date registered
4/03/2015
Date last updated
14/03/2019
Date data sharing statement initially provided
14/03/2019
Date results information initially provided
14/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sexual Healing: A randomised, controlled trial on the effect of pre-operative sexual counselling on sexuality and quality of life after risk-reducing salpingo-oophorectomy.
Scientific title
Sexual Healing: A randomised, controlled trial on the effect of pre-operative sexual counselling on sexuality and quality of life after risk-reducing salpingo-oophorectomy in women at high risk of ovarian cancer
Secondary ID [1] 286174 0
Nil known
Universal Trial Number (UTN)
U1111-1167-2413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual function following risk-reducing bilateral salpingo-oophorectomy in women at high risk of ovarian cancer. 294199 0
Menopausal symptoms following risk-reducing bilateral salpingo-oophorectomy in women at high risk of ovarian cancer. 294200 0
Condition category
Condition code
Surgery 294515 294515 0 0
Other surgery
Reproductive Health and Childbirth 294656 294656 0 0
Other reproductive health and childbirth disorders
Cancer 294709 294709 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 1 hour pre-operative counselling session with a sexologist.
Sexual counselling primarily involves assessment and education, to support women, to discuss their sexual wellbeing and to encourage them to talk about any sexual concerns which they may be experiencing as an individual or in their relationships. A one hour long counselling session may address the following issues:
*Potential effects of surgery on sexual function and physical changes
*Potential changes to intimacy
*Loss of sexual self-esteem related to body image changes, menopausal symptoms and confidence
*Changes to sexual response such as reduced arousal, loss of libido, difficulty reaching orgasm
*Menopausal symptoms related to treatment including hot flushes/night sweats, disturbed sleep, poor memory and weight gain, all of which may impact on one’s sexual self esteem, sexual functioning and general wellbeing (quality of life)
*Loss of confidence and anxiety or fear about resuming sexual activity following surgery and the impact of this on their partner
*Some women experience a reduction in physical and emotional intimacy within their relationship
*Communication about sex can be difficult for couples, especially if they have never broached the subject previously, and this silence can often be mistaken as a lack of interest or rejection.
Intervention code [1] 291179 0
Prevention
Comparator / control treatment
Routine care is the initial (pre-operative) consultation with the Gynaecologic Oncologist.
Control group
Active

Outcomes
Primary outcome [1] 294298 0
Female Sexual Function.
This will be assessed bythe Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale (FSDS).
Timepoint [1] 294298 0
At study enrollment (pre-operatively), 3, 6 and 12 months post surgery.
Secondary outcome [1] 312986 0
To determine if there are any factors that significantly affect a woman’s sexual function or quality of life after risk-reducing bilateral salpingo-oophorectomy.
This will be assessed by the Short Form Health Survey (SF-36) and the Body Image Self-Consciousness Scale (BICS).
Timepoint [1] 312986 0
At study enrollment (pre-operatively), 3, 6 and 12 months post surgery.
Secondary outcome [2] 312987 0
To determine if there is a correlation between serum testosterone levels and sexual function after risk-reducing bilateral salpingo-oophorectomy.
Timepoint [2] 312987 0
6 months post surgery.

Eligibility
Key inclusion criteria
Women who are at increased risk of ovarian cancer who have decided to undergo risk-reducing salpingo-oophorectomy.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with suspected ovarian cancer
Patients with a previous history of breast cancer
Patients with major psychiatric illness on psychotropic medication

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited in the consulting rooms of the gynaecologic oncologist who will be performing the risk-reducing bilateral salpingo-oophorectomy, following their initial consultation. Allocation concealment will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data will be analysed in consultation with a biostatistician and will use the Intent-to-treat principal and per protocol analysis. ANCOVA Generalised Linear Models will be used to compare the test for differences between groups in terms of questionnaire scores. Multivariate logistic regression will be used to test the odds of sexual dysfunction and poor quality of life between groups and test for association with known risk factors and variables such as menopausal symptoms, relationship status, age, cancer fear, satisfaction with surgery and androgen levels. All parameter estimates will be presented with appropriate 95% confidence intervals. We will use an alpha level of 0.05 for all statistical tests, and also report exact p-values. The data analysis will follow CONSORT guidelines.
We are planning a study of a continuous response variable (FSFI score) from independent control and intervention subjects with 1 control per experimental intervention subject. In a previous study (Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function. J Sex Marital Ther. 2000; 26 (2): 191-208) the response within each subject group was normally distributed with standard deviation of 6. If the true difference (delta) in the experimental and control means is 5 (for FSFI score), we will need to study 24 experimental intervention subjects and 24 control subjects to be able to reject the null hypothesis that the population means of the experimental intervention and control groups are equal with probability (power) 0.880%. The Type I error probability associated with this test of this null hypothesis is p=0.05. Therefore, we intend to recruit at least 24 patients per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3449 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 9219 0
6008 - Subiaco
Recruitment postcode(s) [2] 9220 0
6007 - West Leederville
Recruitment postcode(s) [3] 9221 0
6009 - Broadway Nedlands
Recruitment postcode(s) [4] 9223 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 290744 0
Hospital
Name [1] 290744 0
St John of God Hospital
Address [1] 290744 0
12 Salvado Road
Subiaco
WA 6008
Country [1] 290744 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hospital
Address
12 Salvado Road
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 289428 0
None
Name [1] 289428 0
Address [1] 289428 0
Country [1] 289428 0
Other collaborator category [1] 278349 0
University
Name [1] 278349 0
University of Notre Dame
Address [1] 278349 0
32 Mouat Street, Fremantle, WA 6959
Country [1] 278349 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292375 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 292375 0
12 Salvado Road
Subiaco
WA 6008
Ethics committee country [1] 292375 0
Australia
Date submitted for ethics approval [1] 292375 0
29/12/2014
Approval date [1] 292375 0
11/02/2015
Ethics approval number [1] 292375 0
773
Ethics committee name [2] 295167 0
University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [2] 295167 0
19 Mouat St
Fremantle WA 6160
Ethics committee country [2] 295167 0
Australia
Date submitted for ethics approval [2] 295167 0
14/04/2015
Approval date [2] 295167 0
28/04/2015
Ethics approval number [2] 295167 0
015057F

Summary
Brief summary
This study will determine the effect of pre-operative sexual counselling on sexuality and quality of life after risk reducing salpingo-oophorectomy (RRSO) in women at high risk of ovarian cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, at high risk of ovarian cancer and have decided to undergo risk-reducing salpingo-oophorectomy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a single pre-operative counselling session with a sexologist to discuss the potential effects of surgery on sexual function and physical changes, potential changes to intimacy, loss of sexual self-esteem related to body image changes, menopausal symptoms and confidence, changes to sexual response such as reduced arousal, loss of libido, difficulty reaching orgasm, menopausal symptoms related to treatment including hot flushes/night sweats, disturbed sleep, poor memory and weight gain, all of which may impact on one’s sexual self esteem, sexual functioning and general wellbeing (quality of life).
While participants in the other group will receive routine care which is the initial consultation with your gynaecologic oncology specialist who may or may not discuss such issues with you. Participants will be followed-up for up to 12 months post-surgery to determine the effect on sexual function, the prevalence and severity of sexual difficulties after RRSO, and any other factors that significantly affect sexual function and quality of life. Serum testosterone levels will also be tested to determine whether there is a correlation with sexual function after RRSO.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54926 0
Dr Paige Tucker
Address 54926 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 54926 0
Australia
Phone 54926 0
+61893826111
Fax 54926 0
Email 54926 0
paige.tucker@sjog.org.au
Contact person for public queries
Name 54927 0
Dr Paul Cohen
Address 54927 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 54927 0
Australia
Phone 54927 0
+61893826111
Fax 54927 0
Email 54927 0
paul.cohen@uwa.edu.au
Contact person for scientific queries
Name 54928 0
Dr Paul Cohen
Address 54928 0
St John of God Hospital
12 Salvado Road
Subiaco
WA 6008
Country 54928 0
Australia
Phone 54928 0
+61893826111
Fax 54928 0
Email 54928 0
paul.cohen@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary