Clinical trial · Interventional
Living Well After Breast Surgery
- 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)
Decision making about whether to have breast reconstruction after mastectomy can be difficult, and previous studies have found that many women are not well informed about their options. Patient decision aids can improve decision quality for a variety of health conditions. This pilot randomized study seeks to determine how a patient decision aid about breast reconstruction affects the quality of decisions about reconstruction including patient knowledge, concordance between preferences and treatment, and decisional regret.
Conditions
Conditions (7)
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 Female | — | UNRESOLVED | — |
| Ductal Breast Carcinoma | Breast Ductal Carcinoma | ALIAS | 0.90 |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Lobular Breast Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction decision aid | Other | — | UNRESOLVED |
| Educational website | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants randomized to the intervention group will receive a breast reconstruction decision aid. Participants will be provided instructions on how to access and navigate the decision aid. Participants will access the decision aid through a website link that is emailed to them or on a tablet at the study site.
- interventionNames
- Other: Breast reconstruction decision aid
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Participants randomized to the control group will receive two website pages on healthy living with breast cancer from an educational website. Participants will be provided instructions on how to access and navigate the website pages. Participants will access the website pages through a link that is emailed to them or on a tablet at the study site.
- interventionNames
- Other: Educational website
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Adult (18 years or older) * New diagnosis of incident or recurrent Stage I-III ductal or lobular carcinoma, or Ductal Carcinoma in Situ (DCIS) * Not yet had mastectomy * Considering or planning to have mastectomy * Able to read and speak English * Competent to make health care decisions Exclusion Criteria: * Male * Age less than 18 years * Diagnosis of stage IV breast cancer, inflammatory breast cancer, phyllodes, or sarcoma * Already had mastectomy for this diagnosis * Planning to have breast conservation therapy * Not being treated by a Texas Oncology surgeon or oncologist * Not able to read and speak English * Not competent to make health care decisions
References
Publications (0)
Data not yet available