Clinical trial · Interventional
Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
NCT05140252CI-TRIAL-00072440completedN/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)
The aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.
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 |
|---|---|---|---|
| Breast cancer decision aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer decision aid
- description
- Participants receive a breast cancer decision aid.
- interventionNames
- Behavioral: Breast cancer decision aid
Primary outcomes (3)
- measure
- Acceptability of Intervention (AIM) Survey
- timeFrame
- 1 week after receiving decision aid
- description
- AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree \[1\] - Completely Agree \[5\]), scored as a mean. The median score across all participants will be reported.
- measure
- Intervention Appropriateness Measure (IAM)
- timeFrame
- 1 week after receiving decision aid
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria * Early stage breast cancer that is hormone receptor positive (HR+) and human epidermal growth factor negative (HER2-) * Meet criteria for omission of sentinel lymph node biopsy (SLNB) * Receiving care at Michigan Medicine Exclusion Criteria * Non-English speaking * Male patients (current data does not support omission of SLNB in men)
References
Publications (1)
- BACKGROUNDSchonberg MA, Freedman RA, Recht AR, Jacobson AR, Aliberti GM, Karamourtopoulos M, Nakhlis F, McCarthy EP, Pories SE, Sharma R, Dominici LS. Developing a patient decision aid for women aged 70 and older with early stage, estrogen receptor positive, HER2 negative, breast cancer. J Geriatr Oncol. 2019 Nov;10(6):980-986. doi: 10.1016/j.jgo.2019.05.004. Epub 2019 May 24. PMID 31130442