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MEND 2: Making Treatment Decisions Using Genomic Testing

NCT03183050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-04-30

Study results available
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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.

Conditions

  • Breast Cancer Female

Interventions

BEHAVIORAL

Question Prompt List

Patients receive a booklet that contains questions regarding their diagnosis, testing and treatment.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Barbara Ann Karmanos Cancer Institute

    collaborator OTHER

  • Georgetown University

    lead OTHER

Principal Investigators

  • Suzanne C O'Neill, PhD · Georgetown University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2019-01-14
Completion
2019-01-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183050 on ClinicalTrials.gov