Knowledge and Attitudes of Patients and Healthcare Professionals on a Spectrum of Genetic Tests Relevant to Breast Cancer Patients
| Tracking Information | |||||
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| First Received Date ICMJE | April 2, 2012 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Conduct a questionnaire survey in a South-East Asian tertiary institution The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary institution, to assess whether breast cancer patients and their physicians would consider the use of three different kinds of genetic tests currently available to breast cancer patients: BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01619306 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To explore factors which might influence their decisions on genetic testing To explore factors which might influence their decisions on genetic testing, including:
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Knowledge and Attitudes of Patients and Healthcare Professionals on a Spectrum of Genetic Tests Relevant to Breast Cancer Patients | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Objectives: Primary objectives: • The investigators aim to conduct a questionnaire survey in a South-East Asian tertiary institution, to assess whether breast cancer patients and their physicians would consider the use of three different kinds of genetic tests currently available to breast cancer patients:
Secondary objectives: To explore factors which might influence their decisions on genetic testing, including:
The questionnaire for healthcare professionals contains a brief section on demographics and past experience with genetic testing. Three hypothetical situations are described to determine if healthcare professionals will recommend their patients for BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 12 categorical questions explore the reasons for their decision, and physicians are required to rank these in order of importance. Distribution of questionnaires: Questionnaires will be handed out to agreeable participants on the following occasions:
No subject identity will be collected for these questionnaires. Rationale and Hypothesis: BRCA1/2 germline testing, CYP2D6 genotyping and Oncotype DX® testing have all been approved for use in clinical practice, but controversy still exists surrounding their utility, and apart from BRCA1/2 mutation testing in high-risk individuals, genetic tests are not routinely performed in Singapore. BRCA1/2 germline mutation testing is performed in individuals at high risk for hereditary cancer. CYP2D6 genotype testing predicts the benefit of adjuvant tamoxifen therapy; poor and intermediate metabolisers of tamoxifen may have a higher risk of breast cancer recurrence due to lower efficacy of tamoxifen because of less efficient conversion of tamoxifen to endoxifen, the active metabolite of tamoxifen. Oncotype DX® testing is a gene-expression profiling test performed on a formalin-fixed paraffin embedded tumour specimen, to predict the risk of breast cancer recurrence and guide decisions on adjuvant chemotherapy. Understanding the attitudes of patients and medical professionals toward these genetic tests may help to guide medical oncologists in their clinical recommendations and utilization of these tests in breast cancer patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Questionnaires will be handed out to agreeable participants on the following occasions. 1. Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas 2. Medical students - before or after lectures, or at personal contact 3. Cancer researchers - before or after lectures, or at personal contact 4. Healthcare professionals - before or after NUHS breast tumour board, or at personal contact Due caution will be exercised to ensure that the questionnaire is only handed out to subjects who are aged 21 years and above. |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 850 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01619306 | ||||
| Other Study ID Numbers ICMJE | 2010/00752 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | National University Hospital, Singapore | ||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | National University Hospital, Singapore | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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