MEND 2: Making Treatment Decisions Using Genomic Testing
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 2/17/2019 |
| Start Date: | June 2, 2017 |
| End Date: | January 14, 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- Women aged 40-75 who receive Oncotype DX testing are eligible.
Exclusion Criteria:
- Cognitive impairment that precludes informed consent and inability to converse in
English given the focus on communication in this study. Clinical communication between
providers and patients with limited English proficiency is beyond the scope of this
work.
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