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

NCT ID: NCT02261311

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Quality of Life

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angel Arnaout, Surgeon

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Angel Arnaout, Surgeon

Role: CONTACT

613-737-7700 ext. 79071

Facility Contacts

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Angel Arnaout, Surgeon

Role: primary

613-737-7700 ext. 79071

Other Identifiers

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20130232-01H

Identifier Type: -

Identifier Source: org_study_id

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