An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention (RADSII)
September 15, 2016 updated by: Ottawa Hospital Research Institute
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women with BIRADS 4/5 on initial mammogram.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Quality of Life, tissue collection
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of life
Time Frame: up to 6 weeks
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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.
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up to 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Angel Arnaout, Surgeon, The Ottawa Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2017
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
September 25, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (Estimate)
October 10, 2014
Study Record Updates
Last Update Posted (Estimate)
September 16, 2016
Last Update Submitted That Met QC Criteria
September 15, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20130232-01H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.