Clinical trial · Observational
An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention
NCT02261311CI-TRIAL-00023900RADSIIunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of Life | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Quality of Life, tissue collection
- description
- 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.
- interventionNames
- Other: Quality of Life
Primary outcomes (1)
- measure
- Quality of life
- timeFrame
- up to 6 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.