Clinical trial · Interventional
Enhancing Shared Decision-Making in Breast Cancer
- 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 objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our primary outcome will be the increase in percentage of patients reporting a perception of shared decision-making. Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making. Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the percentage of providers perceiving SDM with the patient, number of treatment options offered to patients, the proportion of times that clinical trials are offered to patients, the use of NCCN guideline-based treatment, and self-report of treatment plan use. Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether providers elicit: any patient preferences during treatment planning, preferences related to physical side effects or efficacy, or preferences related to other aspects of the patient experience. We will also assess whether providers use the TP in the decision-making discussion and whether providers discuss or offer clinical trials to the patient.
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 |
|---|---|---|---|
| Shared Decision Making | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention-specific Carevive questionnaire | Other | — | UNRESOLVED |
| Standard of Care questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shared Decision Making Questionnaire
- description
- * Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP. * One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap.
- interventionNames
- Other: Intervention-specific Carevive questionnaire
- type
- OTHER
- label
- Standard of Care Questionnaire
- description
- * Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made. * One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap.
- interventionNames
- Other: Standard of Care questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women age ≥ 18 * Presence of breast cancer * Receiving any line and type of therapy (including both standard of care and clinical trials) Exclusion Criteria: * Patients who are not able to read and/or speak English * Patients who are not being offered any medical therapy (hormone therapy, chemotherapy, targeted therapy) for their breast cancer * Patients with a life-expectancy of less than 3 months * Patients unable to provide informed consent * Men * Patients who do not plan to receive treatment at UAB or MCI
References
Publications (1)
- DERIVEDRocque GB, Eltoum N, Caston NE, Williams CP, Oliver MM, Moradi L, Ingram S, Azuero A, Pisu M, Bhatia S. A randomized controlled trial of shared decision-making treatment planning process to enhance shared decision-making in patients with MBC. Breast Cancer Res Treat. 2024 Aug;206(3):483-493. doi: 10.1007/s10549-024-07304-y. Epub 2024 Jun 10. PMID 38856885