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NCT03183050 · ClinicalTrials.gov registry record · NA
MEND 2: Making Treatment Decisions Using Genomic Testing
A NA study, sponsored by Georgetown University.
- Completed
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT03183050 is a NA study that has completed, run by Georgetown University. The registered enrollment target is 88 participants.
The verdict
NCT03183050, a NA study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Question Prompt List
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2017-06-02 |
| Est. Completion | 2019-01-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03183050
The ClinicalTrials.gov registry entry for NCT03183050 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Question Prompt List is the first listed.
NCT03183050 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03183050 about?
NCT03183050 is a clinical study titled "MEND 2: Making Treatment Decisions Using Genomic Testing". 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 f...
What is the current status of trial NCT03183050?
This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2017-06-02. Estimated completion is 2019-01-14.
What interventions are being tested in trial NCT03183050?
The interventions under investigation include: Question Prompt List (BEHAVIORAL).
Who is sponsoring clinical trial NCT03183050?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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