An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention (RADSII)

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Quality of Life

Study type: Observational

Funder types: Other

Identifiers

NCT02261311

20130232-01H

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Previous neo-adjuvant therapy
• Patients with recurrent disease

Trial design

200 participants in 1 patient group

Quality of Life, tissue collection

Description:

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.

Treatment:

Other: Quality of Life