MEND 2: Making Treatment Decisions Using Genomic Testing

NCT03183050 | Completed Results

• 1 other identifier: 2016-1117
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Question Prompt List

EXPERIMENTAL

Paper booklet including question prompt list.

Behavioral: Question Prompt List

Interventions

Question Prompt List BEHAVIORAL

Patients receive a booklet that contains questions regarding their diagnosis, testing and treatment.

Question Prompt List

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 40-75 who receive Oncotype DX testing are eligible.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• Barbara Ann Karmanos Cancer Institute: collaborator

Study Sites (2)

Medstar Cancer Network

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• 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.

  PMID: 32900604 RESULT

• 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.

  PMID: 32463763 RESULT

Results Point of Contact

• Title: Suzanne O'Neill
• Organization: Georgetown University

sco4@georgetown.edu

202-687-0869

Study Officials

• Suzanne C O'Neill, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: June 2, 2017
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Clean, de-identified dataset can be made available once analyses associated with study aims are complete.
• Access Criteria: Investigator must be willing to follow all procedures requested by IRB of record.

Locations

US (2)