Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000185763
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
15/02/2013
Date last updated
16/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Facilitating Effective Communication and Coping among Women tested for BRCA1/2 Mutations and their Male Partners
Scientific title
Randomised trial among women undergoing genetic testing for breast/ovarian cancer and their male support partners to evaluate the impact of the 'Supporting Men, Supporting Women' web-based intervention, compared with participants assigned to the wait-list control group, and its impact on distress, perceived relational support, satisfaction with genetic-related information and knowledge about genetic testing.
Secondary ID [1] 281958 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 288377 0
Unmet information needs 288378 0
Unmet emotional and relational needs 288379 0
Inability to provide relational support 288380 0
Condition category
Condition code
Cancer 288720 288720 0 0
Breast
Human Genetics and Inherited Disorders 288721 288721 0 0
Other human genetics and inherited disorders
Mental Health 288722 288722 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Supporting Men, Supporting Women' web-based intervention aims to increase men’s understanding of the genetic testing process and to facilitate their personal coping, as well as their ability to communicate and provide support to woman at risk for developing breast and/or ovarian cancer.

'Supporting Men, Supporting Women' is organised in a menu-driven modular format, with each module addressing an identified area of concern and need for male support partners. As well as providing a thorough explanation of the genetic testing process, it offers information about women’s typical and preferred coping responses, and the implications of different testing results, including surveillance and preventive options. The intervention is unique in that it also provides information from the male perspective including: common responses of male partners to being a support person; ways for men to cope with these responses; guidance for how male partners can support the woman through testing process (including videos providing simple strategies for recognising and reducing stress); and, how couples can effectively communicate with each other and with other family members about genetic testing and its implications.

In addition to usual care received throughout the genetic testing process (genetic testing of a blood sample as well as genetic counseling prior to, and following, test result disclosure), both male and female participants in the intervention group will receive full and immediate access to the Supporting Men, Supporting Women web-based intervention for the duration of the study (4 months). Please note that there is no minimum or maximum amount of time participants are required to use this website.
Intervention code [1] 286525 0
Behaviour
Comparator / control treatment
The control group will receive usual care from the recruiting Hereditary Cancer Clinics and will be wait-listed to receive access to the intervention after the 4-month study period.
Control group
Active

Outcomes
Primary outcome [1] 288866 0
Testing-specific distress, as measured by the Impact of Event Scale-Revised (IES-R)
Timepoint [1] 288866 0
All timepoints (baseline, and 1- and 4- months post-intervention)
Primary outcome [2] 288867 0
Generalized distress, as measured by the Depression, Anxiety, Stress Scales (DASS-21)
Timepoint [2] 288867 0
All timepoints (baseline, and 1- and 4- months post-intervention)
Secondary outcome [1] 301188 0
Satisfaction with the ability to provide support (for men) or satisfaction with support received (for women), each assessed with our previously published support scale.
Timepoint [1] 301188 0
All timepoints (baseline, and 1- and 4- months post-intervention)
Secondary outcome [2] 301189 0
Unmet needs related to emotional and relational issues surrounding genetic testing, assessed with the Cancer Survivors’ Unmet Needs Measure (CaSUN; for women) and the Cancer Survivors’ Partners Unmet Needs Measure (CaSPUN; for men), each modified for use in the genetic testing context
Timepoint [2] 301189 0
All timepoints (baseline, and 1- and 4- months post-intervention)
Secondary outcome [3] 301190 0
BRCA1/2-related genetics knowledge, as measured by an 8-item genetics knowledge measure used in our prior research
Timepoint [3] 301190 0
All timepoints (baseline, and 1- and 4- months post-intervention)
Secondary outcome [4] 301191 0
Satisfaction with genetics-related information, as measured by a modified version of the Satisfaction with Information Scale
Timepoint [4] 301191 0
All timepoints (baseline, and 1- and 4- months post-intervention)

Eligibility
Key inclusion criteria
Eligibility criteria for inclusion of women in the study will be (a) over 18 years of age; (b) a candidate for BRCA1/2 testing for breast/ovarian cancer susceptibility, (c) access to a computer connected to the internet; (d) ability to read and understand English; (e) informed consent and (f) nominated male support partner.

Eligibility criteria for inclusion of men in the study will be (a) over 18 years of age; (b) supporting a woman through BRCA1/2 testing for breast cancer susceptibility (may be the woman’s husband or partner, brother, father, uncle or friend), (c) access to a computer connected to the internet; (d) ability to read and understand English and (e) informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who do not have a male support partner or who are not undergoing genetic testing for breast/ovarian cancer risk.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/03/2014
Actual
3/05/2014
Date of last participant enrolment
Anticipated
Actual
3/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
780
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286732 0
University
Name [1] 286732 0
Macquarie University
Country [1] 286732 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde, New South Wales, 2109
Country
Australia
Secondary sponsor category [1] 285508 0
None
Name [1] 285508 0
Address [1] 285508 0
Country [1] 285508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288806 0
Human Research Ethics Committee
Ethics committee address [1] 288806 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 288806 0
Australia
Date submitted for ethics approval [1] 288806 0
Approval date [1] 288806 0
15/10/2012
Ethics approval number [1] 288806 0
HREC/12/POWH/94

Summary
Brief summary
This study will assess the efficacy of the 'Supporting Men, Supporting Women' website in providing information for men supporting women through genetic testing for breast/ovarian cancer. It aims to help men understand and cope with genetic testing, and communicate and support women throughout this process. We expect that individuals accessing this website will have low levels of distress, feel satisfied with the extent of support offered and received in their relationship, have high knowledge of genetic testing and feel satisfied with genetic information.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37862 0
Dr Kerry Sherman
Address 37862 0
Centre for Emotional Health
Department of Psychology, C3A 705
Macquarie University NSW 2109
Country 37862 0
Australia
Phone 37862 0
+61 2 9850 6874
Fax 37862 0
Email 37862 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 37863 0
Dr Kerry Sherman
Address 37863 0
Centre for Emotional Health
Department of Psychology, C3A 705
Macquarie University NSW 2109
Country 37863 0
Australia
Phone 37863 0
+61 2 9850 6874
Fax 37863 0
Email 37863 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 37864 0
Dr Kerry Sherman
Address 37864 0
Centre for Emotional Health
Department of Psychology, C3A 705
Macquarie University NSW 2109
Country 37864 0
Australia
Phone 37864 0
+61 2 9850 6874
Fax 37864 0
Email 37864 0
kerry.sherman@mq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.