MEND 2: Making Treatment Decisions Using Genomic Testing (MEND2)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Behavioral: Question Prompt List

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Medstar Cancer Network
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Question Prompt List; Paper booklet including question prompt list.	Behavioral: Question Prompt List; Patients receive a booklet that contains questions regarding their diagnosis, testing and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge Related to Testing and Treatment	Knowledge was measured for testing, treatment and overall. Responses included true/false/don't know with a point per correct answer. Testing knowledge was assessed with a 12-item scale from Richman et al. (2011), with an overall score from 0-12. Treatment knowledge was assessed with 5 items from the Breast Cancer Systemic Therapy Decision Quality Instrument (Lee et al., 2014; overall score of 0-5). Knowledge was scored separately for testing and treatment, as well as summed for a total knowledge score (0-17), which is used as the primary outcome. Higher scores correspond to more knowledge.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehension in chemotherapy preferences as assessed by a scale	Change in preferences for chemotherapy from baseline to post-intervention	One month

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: H. Lee Moffitt Cancer Center and Research Institute; Barbara Ann Karmanos Cancer Institute
• Investigators: Principal Investigator: Suzanne C O'Neill, PhD, Georgetown University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): January 14, 2019
• Study Completion (Actual): January 14, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2016-1117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will include self-reported survey data, data obtained from chart review and audio recorded encounters. We will make de-identified data available by request to investigators not associated with the study. Priority for sharing of data will be given to junior faculty and/or faculty interested in questions related to translational science. Any requests for data from non-study investigators will be reviewed by the investigative team to ensure that it does not conflict with planned analyses, is otherwise respectful of the study participants, and complies with all relevant IRB and HIPAA regulations.
• IPD Sharing Time Frame: Clean, de-identified dataset can be made available once analyses associated with study aims are complete.
• IPD Sharing Access Criteria: Investigator must be willing to follow all procedures requested by IRB of record.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No