Clinical trial · Observational
Development of a Patient Decision Aid for Women Considering Breast Reconstruction
Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing
- 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)
This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Intervention | Other | — | UNRESOLVED |
| Media Intervention | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm 1
- description
- Patients view a video and read a workbook over 30 minutes about breast reconstruction surgery before their appointment. Patients also complete a questionnaire over 5-10 minutes before and after the video and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any).
- interventionNames
- Other: Educational Intervention
- Other: Media Intervention
- Other: Medical Chart Review
- Other: Questionnaire Administration
- label
- Arm 2
- description
- Patents receive an educational booklet about breast reconstruction surgery during appointment. Patients also complete a questionnaire over 5-10 minutes before and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any).
- interventionNames
- Other: Usual Care
- Other: Medical Chart Review
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aims 1 and 2: Patients who are 6 months to 3 years post-mastectomy surgery * Aim 3: Patients who are scheduled for their first breast reconstruction consultation with plastic surgery * Able to speak, read, and write English Exclusion Criteria: * Women with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in their medical record) * Women for whom the video and workbook would not be appropriate due to clinical characteristics or contraindications (as determined by a provider)
References
Publications (0)
Data not yet available