Trial Outcomes & Findings for MEND 2: Making Treatment Decisions Using Genomic Testing (NCT NCT03183050)

NCT ID: NCT03183050

Last Updated: 2025-04-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: One month
• Results posted on: 2025-04-30

Participant Flow

Participant milestones

Measure	Received QPL Each participant of this single-arm trial received the QPL
Overall Study STARTED	88
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Received QPL Each participant of this single-arm trial received the QPL
Overall Study Lost to Follow-up	23

Baseline Characteristics

MEND 2: Making Treatment Decisions Using Genomic Testing

Baseline characteristics by cohort

Measure	Received QPL n=65 Participants Each participant of this single-arm trial received the QPL
Age, Continuous	60.2 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Knowledge Related to Testing and Treatment	10.95 units on a scale STANDARD_DEVIATION 2.98 • n=5 Participants

PRIMARY outcome

Timeframe: One month

Population: All consented participants who completed both time points

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.

Outcome measures

Measure	Received QPL n=65 Participants Each participant of this single-arm trial received the QPL
Knowledge Related to Testing and Treatment	12.36 units on a scale Standard Deviation 13.0

Adverse Events

Received QPL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne O'Neill

Georgetown University

Phone: 202-687-0869

Email: sco4@georgetown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place