Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
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  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001272381
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
4/09/2017
Date last updated
8/04/2021
Date data sharing statement initially provided
9/01/2019
Date results provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer
Scientific title
Evaluation of the incidence and type of psychosocial needs in 14-24 year old offspring of women with early or metastatic breast cancer
Secondary ID [1] 292730 0
BCRC116
Universal Trial Number (UTN)
Trial acronym
Breast Cancer Offspring Study (BCOS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial needs 304495 0
Breast cancer 304496 0
Condition category
Condition code
Mental Health 303832 303832 0 0
Studies of normal psychology, cognitive function and behaviour
Cancer 303882 303882 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants sign a consent form to confirm in writing they agree to take part in the trial and provide contact details to the study team. Once received, trial staff will phone participants to obtain demographic information about gender, age, schooling, place of birth, family situation (who they live with), whether they have any important medical conditions and any cancer history of their immediate family. Participants will be emailed a link to an online survey comprised of 2 questionnaires online which they are required to complete within 28 days . We anticipate time to participate and complete all aspects of the trial will take individuals a total of 30-40 minutes.
Intervention code [1] 298974 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303194 0
To assess the incidence and type of psychosocial needs and distress experienced in 14-24 year-old offspring (males and females) of women with early or metastatic breast cancer. This is a composite primary outcome. This will be assess using a questionnaire designed specifically for this study.
Timepoint [1] 303194 0
At completion of the questionnaire
Secondary outcome [1] 338202 0
Demographic variables in the offspring associated with greater degree and severity of needs experienced. This outcome will be assessed using a questionnaire designed specifically for this study
Timepoint [1] 338202 0
At completion of the questionnaire.
Secondary outcome [2] 338203 0
Characteristics of the breast cancer stage and treatment received by their parent that are associated with a greater degree and severity of needs experienced by the offspring. This is a composite secondary outcome. This will be assess using a questionnaire designed specifically for this study.
Timepoint [2] 338203 0
At completion of the questionnaire.
Secondary outcome [3] 338204 0
Differences in demographics, degree and severity of needs experienced if they are CanTeen members or not. This is a composite secondary outcome. This will be assess using a questionnaire designed specifically for this study.
Timepoint [3] 338204 0
At completion of the questionnaire.

Eligibility
Key inclusion criteria
1. Written informed consent of participants (parental consent also required in subjects under 18 years)
2. Written informed consent of the mother “Consent for Use of Personal Health Information”
3. Male and female aged between 14-24yrs at the time of consent
4. Mother diagnosed with stage I to IV breast cancer
5. Able to read English and understand questions asked
6. Participants may be adopted
7. Resides in Western Australia
8. Offspring whose mother with breast cancer is the sole parent are eligible
9. Mother must be a current patient at the research site
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. No social contact with mother who has breast cancer
2. Any personal history of cancer
3. Psychologically or emotionally unable to answer questionnaire as assessed by mother who has breast cancer
4. Any other immediate family member (i.e. another parent, step parent or sibling) receiving treatment for any cancer or diagnosed with any cancer that is not deemed cured.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The OCNI (Offspring Cancer Needs Instrument) 47-item questionnaire and Kessler 10 questionnaire will be utilised to measure offspring needs. Demographic information of the offspring and details of the mother’s disease and treatment will be obtained. The incidence of types and severity of psychosocial needs will be reported as the primary endpoint. Factors including offspring demographics, the patient’s disease stage and treatment received at the time of study will be analysed for which variables are predictive of a higher likelihood of needs experienced in the offspring.
• Consenting offspring will be asked to complete the OCNI and Kessler 10
• Demographic details of offspring will be collected
• Information on patient demographics, disease details, treatment received and breast cancer status will be collated.

Consecutive study participants over a 6-month will be included in the study sample. It is anticipated that up to 100 participants will be recruited. Participants must complete both the OCNI and the Kessler 10 questionnaires to be included in the sample size

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2017
Actual
18/09/2017
Date of last participant enrolment
Anticipated
Actual
7/03/2018
Date of last data collection
Anticipated
Actual
3/05/2018
Sample size
Target
100
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297368 0
Charities/Societies/Foundations
Name [1] 297368 0
Breast Cancer Research Centre-WA
Country [1] 297368 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre-WA
Address
Hollywood Consulting Centre
Suite 407, 4th Floor
91 Monash Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 296345 0
None
Name [1] 296345 0
Address [1] 296345 0
Country [1] 296345 0
Other collaborator category [1] 279693 0
Charities/Societies/Foundations
Name [1] 279693 0
CanTeen
Address [1] 279693 0
Street address: 75 King St, Newtown, NSW 2042 Postal address: GPO Box 3821 Sydney NSW 2001
Country [1] 279693 0
Australia
Other collaborator category [2] 279694 0
Individual
Name [2] 279694 0
Nichola Forster
Address [2] 279694 0
Hollywood Private Hospital Suite 5, Hollywood Specialist Centre 95 Monash Avenue Nedlands, WA 6009
Country [2] 279694 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298472 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 298472 0
Ethics committee country [1] 298472 0
Australia
Date submitted for ethics approval [1] 298472 0
20/03/2017
Approval date [1] 298472 0
16/08/2017
Ethics approval number [1] 298472 0

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

Contacts
Principal investigator
Name 77186 0
Prof Arlene Chan
Address 77186 0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Country 77186 0
Australia
Phone 77186 0
+61 8 94814522
Fax 77186 0
Email 77186 0
[email protected]
Contact person for public queries
Name 77187 0
Karen Shakespeare
Address 77187 0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Country 77187 0
Australia
Phone 77187 0
+61 8 65005555
Fax 77187 0
Email 77187 0
[email protected]
Contact person for scientific queries
Name 77188 0
Arlene Chan
Address 77188 0
Suite 407, Hollywood Consulting Centre, 91 Monash Avenue, Nedlands WA 6009.
Country 77188 0
Australia
Phone 77188 0
+61 8 94814522
Fax 77188 0
Email 77188 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Participating investigators

Conditions for requesting access:
• -

What individual participant data might be shared?
• Data will only be shared amongst participating investigators as pertains to the study endpoints and specified analyses

What types of analyses could be done with individual participant data?
• Analyses as planned per protocol, or as exploratory analyses based on study’s findings which may serve as rationale for further clinical research evaluation

When can requests for individual participant data be made (start and end dates)?
From:
At time of data clean and first data analysis and up until time of final publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data fields from primary study database will be shared as deidentified records in Excel spreadsheet

Are there extra considerations when requesting access to individual participant data?
No


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.