Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000502033
Ethics application status
Approved
Date submitted
12/05/2010
Date registered
17/06/2010
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Too much, too soon? The impact of treatment-focused genetic testing in patients newly diagnosed with breast cancer.
Scientific title
In patients newly diagnosed with breast cancer, will those who receive educational materials about treatment-focused genetic testing experience outcomes (including anxiety, depression, decisional conflict, knowledge of treatment-focused genetic testing, uptake of genetic testing and/or surgery choice) that are no worse than in patients who undergo standard familial cancer centre consultation only.
Secondary ID [1] 251750 0
N/A
Universal Trial Number (UTN)
Trial acronym
Treatment focused And Responsive Genetic Testing (TARGET) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early or locally advanced breast cancer 256912 0
Women at increased risk for carrying a faulty gene for breast and/or ovarian cancer 256913 0
Condition category
Condition code
Cancer 257060 257060 0 0
Breast
Human Genetics and Inherited Disorders 257061 257061 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A brief pamphlet about treatment-focused genetic testing (TFGT) for breast cancer will be posted to women allocated to the intervention group once the baseline questionnaire is complete (about one week after diagnosis). Information covered includes:
- what is TFGT
- why do TFGT
- how the test is done
- implications of test results
Intervention code [1] 256109 0
Other interventions
Comparator / control treatment
Standard familial cancer centre consultation. This normally occurs about two weeks after diagnosis and takes about one hour. Topics that may be discussed include breast and ovarian cancer risk, genetic testing, the implications for self and family.
Control group
Active

Outcomes
Primary outcome [1] 257951 0
Through a non-inferiority trial we will test the hypothesis that patient outcomes (anxiety, depression, decisional conflict, knowledge of treatment-focused genetic testing, uptake of genetic testing and/or surgery choice) will be no worse in the intervention group compared to the control group. Anxiety and depression will be assessed using the validated Hospital Anxiety and Depression scale, decisional conflict will be assessed using the validated Decisional Conflict Scale, knowledge will be assessed using a purposely developed 10 item questionnaire that has been piloted, and uptake will be acertained from medical records.
Timepoint [1] 257951 0
At diagnosis, 1 week, 2 weeks, 6 weeks and 58 weeks.
Secondary outcome [1] 263479 0
Women who opt for treatment-focused genetic testing will have a higher uptake of bilateral mastectomy compared to data from the Royal Australasian College of Surgeons Breast Cancer Audit on over 12,000 women with early breast cancer diagnosed annually. Medical records will be accessed retrospectively to obtain data.
Timepoint [1] 263479 0
12 months after diagnosis

Eligibility
Key inclusion criteria
Women aged between 18 and <50 years with early or locally advanced breast cancer will be eligible if they exhibit at least one of the following risk features:
1. A strong family history of breast and/or ovarian cancer, that is There are now (with the new diagnosis) three or more close relatives on one side of the family with breast or ovarian cancer OR There are now (with the new diagnosis) at least two close relatives on one side of the family with breast or ovarian cancer PLUS a high-risk feature (breast cancer diagnosed before the
age of 40, bilateral breast cancer, breast and ovarian cancer in the same woman, Ashkenazi Jewish ancestry, breast cancer in a male relative)

OR

2. No or minimal family history of breast and/or ovarian cancer AND presence of Bilateral breast cancer AND/OR Ashkenazi Jewish ancestry AND/OR Triple negative breast cancer (oestrogen and progesterone receptor and Human Epidermal growth factor Receptor 2 (HER2) negative tumour)
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have already had genetic counselling at a Familial Cancer Clinic (FCC) and/or testing will
be excluded. Women with metastatic breast cancer (Stage IV) will also be excluded, as their surgical options will be determined largely by disease characteristics rather than choice.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women will be invited to the study by their treating breast surgeon (if possible) at their post-operative consultation when results and treatment plan are discussed. Women will be told that the study is comparing different methods of patient education about treatment-focused genetic testing (TFGT), in which they will also be offered the opportunity to undergo TFGT.Women will be made aware that a decision about whether or not to have TFGT is not urgent, but may be most useful if undertaken before a decision is made to have radiotherapy. Preliminary verbal consent to participate in the study and to be contacted by telephone by the Research Co-Ordinator (RO) will be sought by the surgeon.Women will be offered a choice of completing web-based or mailed hard copy questionnaires. Women who agree to participate in the study will be asked to complete the 1st questionnaire. On receipt of the completed baseline questionnaire, women will be randomised to either the intervention (EM) or the control (standard FCC consultation) group using a standard randomisation program, thereby ensuring allocation concealment. Blinding of staff to the allocation status of each patient is not possible; however, procedures will be put in place to minimise, and monitor for, potential bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A sequence will be generated from a random number generator (such as randomizer.org or random.org)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
11/08/2010
Date of last participant enrolment
Anticipated
Actual
5/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,NSW,WA

Funding & Sponsors
Funding source category [1] 256604 0
Charities/Societies/Foundations
Name [1] 256604 0
Cancer Council Australia
Country [1] 256604 0
Australia
Funding source category [2] 257128 0
Charities/Societies/Foundations
Name [2] 257128 0
Cancer Australia
Country [2] 257128 0
Australia
Funding source category [3] 257129 0
Charities/Societies/Foundations
Name [3] 257129 0
National Breast Cancer Foundation
Country [3] 257129 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 255896 0
University
Name [1] 255896 0
University of NSW
Address [1] 255896 0
High St
Randwick NSW 2031
Country [1] 255896 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259020 0
Sydney West Area Health Service (SWAHS) Human Research Ethics Committee (Westmead Campus)
Ethics committee address [1] 259020 0
Ethics committee country [1] 259020 0
Australia
Date submitted for ethics approval [1] 259020 0
27/04/2010
Approval date [1] 259020 0
04/05/2010
Ethics approval number [1] 259020 0
HREC2010/4/4.20(3152)

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

Contacts
Principal investigator
Name 30900 0
A/Prof Bettina Meiser
Address 30900 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 30900 0
Australia
Phone 30900 0
+61 2 93850025
Fax 30900 0
Email 30900 0
[email protected]
Contact person for public queries
Name 14147 0
Bettina Meiser
Address 14147 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 14147 0
Australia
Phone 14147 0
+61 2 9385 0025
Fax 14147 0
+61 2 9385 0033
Email 14147 0
[email protected]
Contact person for scientific queries
Name 5075 0
Bettina Meiser
Address 5075 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Rm 410, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 5075 0
Australia
Phone 5075 0
+61 2 9385 0025
Fax 5075 0
+61 2 9385 0033
Email 5075 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIHow should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer2012https://doi.org/10.1186/1471-2407-12-320
N.B. These documents automatically identified may not have been verified by the study sponsor.