Clinical trial · Interventional
Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument
NCT00471601CI-TRIAL-00072652completedN/AClinicalTrials.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)
RATIONALE: A questionnaire that evaluates a patient's expectations about breast reconstruction surgery may help doctors improve patient education before surgery and increase patient satisfaction after surgery. PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Behavioral | — | UNRESOLVED |
| psychosocial assessment and care | Behavioral | — | UNRESOLVED |
| quality-of-life assessment | Behavioral | — | UNRESOLVED |
| questionnaire administration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Interviews/Questionnaires
- description
- The primary intervention in part 1 includes the interview for item generation with 50 women and the pilot-testing with a separate group of n = 30 women. The primary intervention in part 2 and 3 is the administration of the questionnaire. In part 3, along with the questionnaire being developed, the Body Image Scale (BIS), the Life Orientation Test-Revised (LOT-R), and the upcoming MSKCC BREAST-Q will be given to determine convergent and discriminant construct validity. No other therapeutic or diagnostic agents will be administered.
- interventionNames
- Behavioral: counseling intervention
- Behavioral: questionnaire administration
- Behavioral: psychosocial assessment and care
- Behavioral: quality-of-life assessment
Primary outcomes (2)
- measure
- Item reduction
- timeFrame
- 2 years
- measure
- Psychometric evaluation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female. * Age \> or = to 18 to 75 years. * Patients who are presenting for consultation about breast reconstruction Exclusion Criteria: * Inability to speak or understanding English * Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability. * Prior breast reconstruction surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.