N/A
Completed N=88
MEND 2: Making Treatment Decisions Using Genomic Testing
Breast Cancer Female
Source: ClinicalTrials.gov NCT03183050 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Knowledge Related to Testing and Treatment — 12.36 units on a scale
Summary
Clinical guidelines for women with early stage breast cancer integrate genomic tumor profiling tests such as the Oncotype DX Recurrence Score to refine recurrence estimates and systemic therapy selection when combined with existing markers. Guidelines suggest that the 25% with a high Score benefit from chemotherapy and the 50% with a low Score can safely avoid chemotherapy. Many challenges remain to maximize the benefits of testing prior to release of trial results in the next year. Strong clinical communication can impact proximal outcomes of patient comprehension, treatment preferences and satisfaction, involvement in care decisions as well as longer-term outcomes of treatment adherence and QOL. These proximal outcomes can be influenced by patient activation interventions utilizing a question prompt list (QPL). In the context of patients receiving Oncotype DX testing, the QPL could allow them to better understand the rationale for their oncologist's treatment recommendation, what it means for managing their disease, and encourage alignment of treatment preferences and selection with the Recurrence Score. Research is conducted in two phases to test the feasibility and impact of the QPL. In Phase 1, the draft QPL will be revised based on in-depth interviews with patients (N=20) and medical oncologists (N=10). Phase 2 will be a single-arm trial (N=75) to demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge Related to Testing and Treatment |
12.36 | — |
Eligibility Criteria
Inclusion Criteria
- Women aged 40-75 who receive Oncotype DX testing are eligible.
Exclusion Criteria
- Cognitive impairment that precludes informed consent and inability to converse in English given the focus on communication in this study. Clinical communication between providers and patients with limited English proficiency is beyond the scope of this work.
Data sourced from ClinicalTrials.gov (NCT03183050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.