An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention
- Conditions
- Breast Cancer
- Interventions
- Other: Quality of Life
- Registration Number
- NCT02261311
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
The investigators will compare the differences in the scores between the baseline questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II patients that enrolled in pre-treatment trials versus those that don't.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- >18 years of age
- Diagnosis of BI-RADS 4 and 5 (highly suspicious for carcinoma) on an initial imaging
- >2cm area of disease
- Provide informed consent
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Exclusion Criteria
- Previous neo-adjuvant therapy
- Patients with recurrent disease
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Quality of Life, tissue collection Quality of Life All participants will complete the GAD-7 and Cancer Locus of Control Scale - Course of Illness Subscale questionnaires and additional tissue will be collected at the time of the diagnostic biopsy.
- Primary Outcome Measures
Name Time Method Quality of life up to 6 weeks To determine if there are improvements in the measurements of anxiety through quality of life questionnaires completed at 2 different time points when participating in a window of opportunity trial verses not participating in a window of opportunity trial.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada