NCT01619306

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:
  • BRCA1/2 germline testing,
  • CYP2D6 genotyping and
  • Oncotype DX® testing. Secondary objectives: To explore factors which might influence their decisions on genetic testing, including:
  • Acceptability of the tests and anti-cancer management based on the test results
  • Reliability and affordability of the test
  • Ability of the test to influence treatment decisions
  • 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:
  • Patients- National University Health System Cancer Centre Level 3 amp; 4 waiting areas
  • Medical students - before or after lectures, or at personal contact
  • Cancer researchers - before or after lectures, or at personal contact
  • 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.9 years

First QC Date

April 2, 2012

Last Update Submit

December 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To explore factors which might influence their decisions on genetic testing

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with early stage breast cancer
  • Healthcare professionals caring for breast cancer patients
  • Medical students /cancer researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationa University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2012

First Posted

June 14, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations