Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000082505
Ethics application status
Approved
Date submitted
24/01/2014
Date registered
2/02/2015
Date last updated
1/02/2022
Date data sharing statement initially provided
28/11/2019
Date results provided
1/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women: A multicentre prospective study
Scientific title
A prospective study on the effects of risk-reducing bilateral salpingo-oophorectomy (RRBSO) in pre-menopausal women at risk of developing ovarian cancer on non-cancer outcomes including sexual function and menopause related quality of life.
Secondary ID [1] 281826 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
WHAM - Women's Health After surgical Menopause
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women at risk of developing ovarian and/or breast cancer who have undergone Risk Reducing Bilateral Salpingo-Oophorectomy (RRBSO) 288175 0
Condition category
Condition code
Cancer 288537 288537 0 0
Ovarian and primary peritoneal
Cancer 288538 288538 0 0
Breast
Reproductive Health and Childbirth 291614 291614 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women at risk of developing ovarian and/or breast cancer who have undergone RRBSO. Non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed using the following:
Blood tests performed at baseline, 12 & 24 months. Time required = 1/2 hour x 3 episodes. Total time =1 and 1/2 hours
Bone mineral density scanning x 3 occasions (baseline, 12 and 24 months) at 1 hour each. Total time = 3 hours.
Completion of questionnaires (N=8) x 5 occasions (baseline, 3, 6, 12 and 24 months) at 1/2 hour each. Total time =
2 hours. Short question and answer tests to measure cognitive function x 3 occasions (baseline, 12 and 24 months) at 45 mins each. Total time = 2 and 1/4 hours.
Intervention code [1] 286380 0
Not applicable
Comparator / control treatment
Age matched control group participants who retain their ovaries and are not at increased risk of ovarian cancer will undergo the same processes as the identified high-risk group.
High risk group women who decide to delay RRBSO for at least 2 years will also be recruited to the comparison group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288697 0
Prospectively measure the effect of RRBSO on sexual function using validated questionnaires:
Fallowfield Sexual Activity Questionnaire (FSAQ)
Female Sexual Function Index (FSFI)
Female Sexual Distress Scale (revised) (FSDS-R)
Timepoint [1] 288697 0
2 years
Primary outcome [2] 291397 0
Prospectively measure effects of RRBSO on Menopausal quality of life using validated questionnaires:
Greene Climacteric Scale
Menopause Specific Quality of Life (MENQOL)
Timepoint [2] 291397 0
2 years
Primary outcome [3] 291398 0
Prospectively measure changes in bone turnover and bone density following RRBSO using serological markers and bone mineral density radiological scanning
Timepoint [3] 291398 0
2 years
Secondary outcome [1] 300777 0
Measure the uptake of Hormone Replacement Therapy in women undergoing RRBSO
Timepoint [1] 300777 0
2 years
Secondary outcome [2] 306670 0
Measure the effects of RRBSO on sleep quality using validated questionnaires:
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 306670 0
2 years
Secondary outcome [3] 306671 0
Measure the effects of RRBSO on cognitive function using a validated question and answer testing format:
Hopkins Verbal Learning Test
Symbol Digit Modality Test
Verbal Fluency Test
Timepoint [3] 306671 0
2 years
Secondary outcome [4] 306739 0
Measure the effects of RRBSO on anxiety and depresion using validated questionnaires:
Centre for Epidemiologic Studies Depression scale (CES-D)
Generalised Anxiety Disorder 7-item scale (GAD-7)
Timepoint [4] 306739 0
2 years

Eligibility
Key inclusion criteria
Aged 18 - 50 years
Regular menstrual periods (if intact uterus)
No current vasomotor symptoms (hot flushes and night sweats)
Early follicular FSH of equal to or less than 15 UI/L
Estradiol > 100 pmol/L
At a high risk of developing breast and/or ovarian cancer
Planning to undergo RRBSO
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous bilateral salpingo-oophorectomy
Taking anti-estrogen agents or tamoxifen in the previous 3 months
Lactating or within 3 months of pregnancy
English non-speakers
Undiagnosed abnormal vaginal bleeding
Current pregnancy (to be excluded with pregnancy test where indicated)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2013
Actual
26/03/2013
Date of last participant enrolment
Anticipated
Actual
8/02/2019
Date of last data collection
Anticipated
19/03/2021
Actual
3/02/2021
Sample size
Target
210
Accrual to date
Final
224
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 459 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 461 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 462 0
Westmead Hospital - Westmead
Recruitment hospital [4] 463 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 5063 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [6] 15354 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28668 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 286609 0
Government body
Name [1] 286609 0
NHMRC
Country [1] 286609 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 285396 0
None
Name [1] 285396 0
Address [1] 285396 0
Country [1] 285396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288683 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288683 0
Ethics committee country [1] 288683 0
Australia
Date submitted for ethics approval [1] 288683 0
Approval date [1] 288683 0
04/12/2012
Ethics approval number [1] 288683 0
HREC/12/PMCC/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37274 0
Prof Martha Hickey
Address 37274 0
University of Melbourne Department of Obstetrics and Gynaecology
Level 7, Research Precinct
Royal Women's Hospital (RWH)
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37274 0
Australia
Phone 37274 0
+613 8345 3719
Fax 37274 0
Email 37274 0
[email protected]
Contact person for public queries
Name 37275 0
Research Coordinator
Address 37275 0
Level 7, Research Precinct
RWH
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37275 0
Australia
Phone 37275 0
+613 8345 3719
Fax 37275 0
+61 3 8345 3702
Email 37275 0
[email protected]
Contact person for scientific queries
Name 37276 0
Martha Hickey
Address 37276 0
University of Melbourne Department of Obstetrics and Gynaecology
Level 7, Research Precinct
RWH
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37276 0
Australia
Phone 37276 0
+613 8345 3719
Fax 37276 0
Email 37276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14879Study protocol https://bmjopen.bmj.com/content/bmjopen/7/11/e018758.full.pdf 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWhat Happens after Menopause? (WHAM): Protocol for a prospective, multicentre, age-matched cohort trial of risk-reducing bilateral salpingo-oophorectomy in high-risk premenopausal women.2017https://dx.doi.org/10.1136/bmjopen-2017-018758
Dimensions AIWHAM—A Prospective Study of Weight and Body Composition After Risk-Reducing Bilateral Salpingo-oophorectomy2023https://doi.org/10.1210/clinem/dgad385
N.B. These documents automatically identified may not have been verified by the study sponsor.