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

NCT02261311 | Unknown

• 1 other identifier: 20130232-01H
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Quality of Life

Interventions

Quality of Life 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.

Quality of Life, tissue collection

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with BIRADS 4/5 on initial mammogram.

You may qualify if:

• \>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

You may not qualify if:

• Previous neo-adjuvant therapy
• Patients with recurrent disease

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Additional tissue samples will be collected at the time of initial biopsy. The samples will be stored for neoadjuvant studies that the patient may choose to participate in during the wait time between diaganosis and surgery.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Angel Arnaout, Surgeon

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Arnaout, Surgeon

CONTACT

613-737-7700; aarnaout@toh.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 10, 2014
• Study Start: March 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

CA (1)