MEND 2: Making Treatment Decisions Using Genomic Testing
Condition: Breast Cancer Female
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Question Prompt List
Intervention type(s): Behavioral
Intervention description(s): Patients receive a booklet that contains questions regarding their diagnosis, testing and treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care