Clinical trial NCT03183050: MEND 2: Making Treatment Decisions Using Genomic Testing
Official title: MEND 2: Making Treatment Decisions Using Genomic Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: Barbara Ann Karmanos Cancer Institute
First posted: 2017-06-09
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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. Women with newly-diagnosed breast cancer will be recruited to a single-arm trial 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge Related to Testing and Treatment
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Cancer Network
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Georgetown University
name: Suzanne C O'Neill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Neill SC, Vadaparampil ST, Street RL Jr, Moore TF, Isaacs C, Han HS, Augusto B, Garcia J, Lopez K, Brilleman M, Jayasekera J, Eggly S. Characterizing patient-oncologist communication in genomic tumor testing: The 21-gene recurrence score as an exemplar. Patient Educ Couns. 2021 Feb;104(2):250-256. doi: 10.1016/j.pec.2020.08.037. Epub 2020 Sep 3.
citation: Jayasekera J, Vadaparampil ST, Eggly S, Street RL Jr, Foster Moore T, Isaacs C, Han HS, Augusto B, Garcia J, Lopez K, O'Neill SC. Question Prompt List to Support Patient-Provider Communication in the Use of the 21-Gene Recurrence Test: Feasibility, Acceptability, and Outcomes. JCO Oncol Pract. 2020 Oct;16(10):e1085-e1097. doi: 10.1200/JOP.19.00661. Epub 2020 May 28.