Trial Outcomes & Findings for Evaluating the Implementation and Impact of Navigator-delivered ePRO System (NCT NCT04809740)

Results Overview

% of eligible patients enrolled

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

3090 participants

Primary outcome timeframe

up to 3 months of starting a treatment for cancer

Results posted on

2026-06-16

Participant Flow

The primary outcome is service penetrance which is the proportion of patients who are eligible who are approached and enroll..

Participant milestones

Participant milestones
Measure	Patients Enrolled in ePROs Patients who are enrolled for ePROs at UAB/MCI
Overall Study STARTED	3090
Overall Study COMPLETED	3090
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Implementation and Impact of Navigator-delivered ePRO System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Group n=3090 Participants Patients from UAB/MCI who are enrolled in remote symptom monitoring (Home ePRO)
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	1669 Participants n=20 Participants
Age, Categorical >=65 years	1421 Participants n=20 Participants
Age, Continuous	61 years STANDARD_DEVIATION 13 • n=20 Participants
Sex: Female, Male Female	1990 Participants n=20 Participants
Sex: Female, Male Male	1100 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=20 Participants
Race (NIH/OMB) Asian	45 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	803 Participants n=20 Participants
Race (NIH/OMB) White	2097 Participants n=20 Participants
Race (NIH/OMB) More than one race	30 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	112 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2239 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	795 Participants n=20 Participants
Region of Enrollment United States	3090 Participants n=20 Participants

PRIMARY outcome

Timeframe: up to 3 months of starting a treatment for cancer

% of eligible patients enrolled

Outcome measures

Outcome measures
Measure	Patient Group n=4145 Participants The population is the patients eligible for enrollment in remote symptom monitoring
Service Penetration	3090 Participants

SECONDARY outcome

Timeframe: up to 48 hours

alerts are measured by abstracting alert data from the ePRO database

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

ePRO surveys are abstracted from the electronic patient-reported outcome system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

ePRO surveys are abstracter from the database; the surveys completed are compared to those sent

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

ePRO surveys are abstracted from the ePRO database including surveys completed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months; up to 6 months

abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months, up to 6 months

Proportion with patients with an ED visit (abstracted from the electronic medical record)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months, up to 6 months

Proportion of patients hospitalized (abstracted from the EMR)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months, up to 6 months

Proportion admitted to the ICU

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 months, up to 6 months

total costs sent by UAB to payers (abstracted from billing records)

Outcome measures

Outcome data not reported

Adverse Events

Patient Group

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

Gabrielle Rocque

University of Alabama at Birmingham

Phone: 2059752914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place