The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer Treatment

February 2, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparities in Cancer Treatment Delay

This study assesses the feasibility and acceptability of a brief electronic patient-reported outcome (ePRO) tool that allows patients to self-identify impending delays. The risk of treatment delays according to tumor type and race will be measured by both ePRO and electronic health record (EHR) tools. Data from this study and the association of social determinants of health could be useful to flag patients at risk of delay and due timely intervention for modifiable treatment barriers. The prediction of the risk of treatment delay will be helpful to design another study using electronic tracking systems to prevent cancer treatment delays. The long-term goal of this research is to alert care teams when patients may be at risk of treatment days and to help patients get treatment faster. It was planned to enroll a total of 240 subjects with newly diagnosed cancer. Sixty colorectal and 180 breast cancer patients will be included.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Katie Reeder-Hayes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

  1. Male and female patients of age >18 years.
  2. Pathologic diagnosis of breasts or colorectal cancer within 6 weeks (42 days) prior to the enrollment date.
  3. Have not yet initiated cancer treatment on the date of enrollment.
  4. Indicate intent to receive cancer treatment at the University of North Carolina.

Exclusion Criteria:

  1. Patient unwilling or unable to receive electronic survey links via email or text link on a mobile device, tablet, laptop, or desktop computer.
  2. Patient unwilling or unable to provide verbal or signed consent to participate.
  3. Patient cannot read and speak English.
  4. Patients who do not have email access or a smartphone are able to receive Short Message/Messaging Service (SMS) text messages.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electronic patient-reported outcome (ePRO) questionnaires.
Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.
Behavioral: Weekly Survey
Subjects will respond to Electronic patient-reported outcome (ePRO) every week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Electronic patient-reported outcome (ePRO)
Time Frame: Baseline to 56 days post-enrollment
Feasibility of Electronic patient-reported outcome (ePRO) will be assessed as the proportion of subjects who responded to at least 4 out of offered 8 weekly ePRO.
Baseline to 56 days post-enrollment
Electronic patient-reported outcome (ePRO) confirming treatment initiation
Time Frame: Baseline to 56 days post-enrollment
Electronic patient-reported outcome (ePRO) confirming treatment initiation will be measured as the proportion of subjects who responded to at least one of the offered weekly ePRO) surveys.
Baseline to 56 days post-enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed Treatment
Time Frame: Baseline to 56 days post-enrollment

Treatment Delay will be measured as the proportion of subjects not receiving ePRO-reported treatment.

If a subject reports on any weekly survey that they have started a treatment for their cancer, selected from a defined list of cancer treatment types this will be considered receiving treatment. Diagnostic procedures, imaging tests, and other medical interventions will not be considered receiving treatment. Patients who respond to surveys indicating no treatment throughout the 56 days of study participation, those who report treatment at a timepoint >56 days from pathologic-confirmed diagnosis, as well as those who do not respond to surveys, will be considered as not receiving treatment for this endpoint.
Baseline to 56 days post-enrollment
Time to ePRO-reported treatment
Time Frame: Baseline to 56 days post-enrollment

Time to ePRO-reported treatment will be assessed as the time from the first documented pathologic confirmation of malignancy (or imaging evidence if biopsy was not obtained) to the first day of the week in which the patient reports receiving treatment as per.

Surveys are completed weekly; thus, the date of treatment is assumed to be the first day of the week in which the patient completes the survey and reports treatment initiation. For instance, if a patient completes a survey on day 32, reporting that they received treatment in the previous week, their date of treatment initiation is assumed to be day 26.
Baseline to 56 days post-enrollment
Proportion of treatment delay
Time Frame: Baseline to 56 days post-enrollment
The proportion of treatment delay will be defined as days between the first documented pathologic confirmation of malignancy to the first therapeutic intervention longer than 56 days divided by the total number of consented patients. Dates will be identified by the study team using a structured abstraction form from either outside medical records captured in the EPIC or UNC EPIC records.
Baseline to 56 days post-enrollment
Time to treatment in days
Time Frame: Baseline to 180 days post-enrollment
Time to treatment in days will be assessed as days between the first documented pathologic confirmation of malignancy to the first therapeutic intervention. Dates will be identified by the study team, using a structured abstraction form from either outside medical records captured in the EPIC or other medical records.
Baseline to 180 days post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Katie Reeder-Hayes, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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