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

Breast Cancer Clinical Trial

— RADSII  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02261311
• Other study ID #: 20130232-01H
• Status: Not yet recruiting
• Phase: N/A
• First received: September 25, 2014
• Last updated: September 15, 2016
• Start date: March 2017
• Est. completion date: October 2017

Study information

• Verified date: September 2016
• Source: Ottawa Hospital Research Institute
• Contact: Angel Arnaout, Surgeon
• Phone: 613-737-7700
• Email: aarnaout[@]toh.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Quality of Life
All participants recruited will complete a questionnaire prior to their breast biopsy and then again approximately one week before their surgery. The questionnaire is focused on the level of anxiety patients experience during the wait time between diagnosis and surgery. Additional tissue will be collected at the time of the diagnostic biopsy.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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.	up to 6 weeks	No