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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: Completed NA study, sponsored by Georgetown University.
NCT03183050 is a NA study that has completed, run by Georgetown University. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Knowledge was measured for testing, treatment and overall. Responses included true/false/don't know with a point per correct answer. Testing knowledge was assessed with a 12-item scale from Richman et al. (2011), with an overall score from 0-12. Treatment knowledge was assessed with 5 items from the Breast Cancer Systemic Therapy Decision Quality Instrument (Lee et al., 2014; overall score of 0-5). Knowledge was scored separately for testing and treatment, as well as summed for a total knowledge
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 |
What the finished NCT03183050 record still lists
NCT03183050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Question Prompt List is the first listed.
NCT03183050 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03183050's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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