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Knowledge and Attitudes of Patients and Healthcare Professionals on a Spectrum of Genetic Tests Relevant to Breast Cancer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619306
First Posted: June 14, 2012
Last Update Posted: December 11, 2013
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National University Hospital, Singapore
  Purpose

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:

  • BRCA1/2 germline testing,
  • CYP2D6 genotyping and
  • Oncotype DX® testing.

Secondary objectives:

To explore factors which might influence their decisions on genetic testing, including:

  1. Acceptability of the tests and anti-cancer management based on the test results
  2. Reliability and affordability of the test
  3. Ability of the test to influence treatment decisions
  4. Broader implications of the test, e.g., psychosocial, financial impact Study design: Cross-sectional study, Survey Questionnaires were developed for 3 categories of individuals:

    • Patients with early stage breast cancer
    • Healthcare professionals caring for breast cancer patients
    • Medical students /cancer researchers The questionnaires for patients and medical students/cancer researchers are similar. The questionnaires contain a brief section on demographic information, interest in and past experience with genetic testing. Three hypothetical situations are described to determine if participants will agree to BRCA1/2 testing, CYP2D6 genotyping and Oncotype DX® testing, respectively. 18 categorical 'yes'/ 'no' questions explore reasons for their decisions. Each scenario requires a short, hand-written response.

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:

  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.

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • To explore factors which might influence their decisions on genetic testing

    To explore factors which might influence their decisions on genetic testing, including:

    1. Acceptability of the tests and anti-cancer management based on the test results
    2. Reliability and affordability of the test
    3. Ability of the test to influence treatment decisions
    4. Broader implications of the test, e.g., psychosocial, financial impact


Estimated Enrollment: 850
Study Start Date: January 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Patients with early stage breast cancer
  • Healthcare professionals caring for breast cancer patients
  • Medical students /cancer researchers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619306


Contacts
Contact: Andrea Wong, MRCP +65 6779 5555 andrea_la_wong@nuhs.edu.sg

Locations
Singapore
Nationa University Hospital Recruiting
Singapore, Singapore
Contact: Andrea Wong, MRCP    +65 6779 5555    andrea_la_wong@nuhs.edu.sg   
Principal Investigator: Andrea Wong, MRCP         
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01619306     History of Changes
Other Study ID Numbers: 2010/00752
First Submitted: April 2, 2012
First Posted: June 14, 2012
Last Update Posted: December 11, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases