Clinical trial · Interventional
Increasing Patients' Engagement in Breast Cancer Surgery Decision-Making
Increasing Socioeconomically Disadvantaged Patients' Engagement in Breast Cancer Surgery Decision Making Through a Shared Decision Making Intervention
NCT03766009CI-TRIAL-00103036active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
Conditions
Conditions (4)
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 Stage 0 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Usual Care | Other | — | UNRESOLVED |
| Web-based decision aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (surgical consultation)
- description
- Prior to institutional crossover, participants receive care as per usual care.
- interventionNames
- Other: Usual Care
- type
- EXPERIMENTAL
- label
- Arm II (web-based breast cancer surgery decision aid)
- description
- Following a 10 week implementation period, at the time of institutional crossover, participants will receive a web-based decision aid prior to the surgical consultation..
- interventionNames
- Other: Usual Care
- Other: Web-based decision aid
Primary outcomes (2)
- measure
- Patient Power: Self-efficacy in Patient Physician Interactions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed with stage 0-III breast cancer * Eligible patients must be planning breast surgery as a component of their definitive treatment * Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * Patients with hearing impairment requiring the use of an interpreter are not eligible for this study * Patients must be able to speak English with the fluency required to have a direct discussion around treatment decision-making (i.e. without interpreter) * CLINIC STAKEHOLDER (SURGEONS AND CLINIC STAFF): Breast surgeon(s) and nursing staff, medical assistant, or mid-level provider at each participating clinic who participates in the care of patients newly diagnosed with breast cancer * INSTITUTIONAL: 10 clinics that annually provide surgical care for 120-300 patients newly diagnosed with breast cancer will be selected to participate in this study * INSTITUTIONAL: Surgeons at eligible clinics must consent to the study as a requirement for site participation
References
Publications (5)
- DERIVEDSaucke MC, Jacobson N, Chow S, McKinney G, Neuman HB. Providing information to prepare breast cancer patients for their surgical consultation: barriers and recommendations (an analysis from Alliance A231701CD). Support Care Cancer. 2026 May 14;34(6):537. doi: 10.1007/s00520-026-10726-7. PMID 42128956
- DERIVEDSchumacher JR, Hanlon BM, Zahrieh D, Rathouz PJ, Tucholka JL, McKinney G, Tan AD, Breuer CR, Bailey L, Higham AM, Wecsler JS, Arnold AH, Froix AJ, Dull S, Abbott AM, Fine SG, McGuire KP, Seydel AS, McNamara P, Chow S, Neuman HB. Impact of a Web-Based Decision Aid on Socioeconomically Disadvantaged Patients' Engagement in Breast Surgery Decision-Making: Stepped-Wedge Clinical Trial (Alliance-A231701CD). Ann Surg Oncol. 2025 Aug;32(8):5540-5550. doi: 10.1245/s10434-025-17452-0. Epub 2025 May 17. PMID 40382452
- DERIVEDSaucke MC, Jacobson N, McKinney G, Neuman HB. Role of the Surgeon in De-Escalating Emotion During a Breast Cancer Surgery Consultation: A Qualitative Study of Patients' Experiences in Alliance A231701CD. Ann Surg Oncol. 2024 Dec;31(13):8873-8881. doi: 10.1245/s10434-024-16156-1. Epub 2024 Sep 25. PMID 39320397
- DERIVEDZahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019. PMID 37923529
- DERIVEDSchumacher JR, Zahrieh D, Chow S, Taylor J, Wills R, Hanlon BM, Rathouz PJ, Tucholka JL, Neuman HB. Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial. BMJ Open. 2022 Nov 17;12(11):e063895. doi: 10.1136/bmjopen-2022-063895. PMID 36396308