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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02261311
Acronym
RADSII
Enrollment
200
Registered
2014-10-10
Start date
2017-03-31
Completion date
2017-10-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast

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.

Interventions

OTHERQuality 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.

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of lifeup to 6 weeksTo 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.

Countries

Canada

Contacts

Primary ContactAngel Arnaout, Surgeon
aarnaout@toh.on.ca613-737-7700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026