MEND 2: Making Treatment Decisions Using Genomic Testing


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Primary Outcome Measures:
Secondary Outcome Measures:

Breast cancer is the most common cancer among US women, with more than 230,000 new diagnoses and 40,000 deaths each year, along with decrements in quality of life. Half of all newly-diagnosed patients are affected with estrogen-receptor positive, early-stage disease. Clinical guidelines for these women 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. Thousands of women receive testing each year. While these women should all receive hormonal therapy, guidelines suggest that the 25% with a high Score benefit from additional chemotherapy and the 50% with a low Score can safely avoid chemotherapy. Appropriate treatment for the 25% of women with intermediate Recurrence Scores remains unclear until clinical trial (TAILORx) results are released in the next year.

Despite continuing dissemination, many challenges remain to maximize the benefits offered by testing and refined treatment selection. TAILORx results will continue to strengthen the evidence for clinical utility and increase testing rates. An effective intervention should be ready to respond to this increasing need. Communication can influence more proximal outcomes, including patient comprehension of their disease and its treatments, treatment preferences and satisfaction, involvement in care decisions as well as longer-term outcomes of treatment adherence and quality of life. This trial will test the feasibility and impact of a patient activation intervention to support effective integration of the Recurrence Score into clinical encounters and treatment decisions. Patient activation interventions utilizing a question prompt list (QPL) can impact proximal outcomes of preferences, comprehension, satisfaction and involvement. In Phase 1, investigators will further refine a draft QPL based on in-depth interviews with patients (N = 20) and medical oncologists (N = 10). In Phase 2, women with newly-diagnosed breast cancer will be recruited to a single-arm trial (N = 75) to demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes. Aims are to:

Aim 1. Examine intervention feasibility. Feasibility will be examined in 3 areas: 1) patient and oncologist acceptability, 2) participant recruitment and retention, and 3) intervention dosage and fidelity.

Aim 2. Evaluate intervention effects on comprehension and treatment preferences. 2a: Participants will demonstrate significant increases in comprehension about their disease and its treatments from pre- to post-QPL. 2b: Participants will be more likely to report Score-concordant preferences from pre to post-QPL.

Aim 3. Assess potential intervention mechanisms on comprehension, preferences and satisfaction. 3a: Patient comprehension and satisfaction will be higher following encounters with greater shared decision making, greater perceived communication quality, and more frequent discussion of risks/benefits of treatments. 3b: Patient preferences will likely be more Score-concordant following encounters with greater shared decision making, greater perceived communication quality, and more frequent discussion of risks/benefits of treatments.

Variation in outcomes will be explored across Aims 1-3 based on patient and provider sociodemographics, patient-provider concordance (gender, race), and patient’s language preference.