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

NCT06096623 | Recruiting DMC

• 1 other identifier: LCCC2315
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Breast Cancer; Colorectal Cancer

Keywords

patient-reported outcome; electronic; health equity; electronic survey; treatment delay

Outcome Measures

Primary Outcomes (2)

• Feasibility of Electronic patient-reported outcome (ePRO)

  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

  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 Outcomes (4)

• Delayed Treatment

  Baseline to 56 days post-enrollment

• Time to ePRO-reported treatment

  Baseline to 56 days post-enrollment

• Proportion of treatment delay

  Baseline to 56 days post-enrollment

• Time to treatment in days

  Baseline to 180 days post-enrollment

Study Arms (1)

electronic patient-reported outcome (ePRO) questionnaires.

EXPERIMENTAL

Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.

Behavioral: Weekly Survey

Interventions

Weekly Survey BEHAVIORAL

Subjects will respond to Electronic patient-reported outcome (ePRO) every week for 8 weeks.

electronic patient-reported outcome (ePRO) questionnaires.

Eligibility Criteria

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

You may qualify if:

• In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
• Male and female patients of age \>18 years.
• Pathologic diagnosis of breasts or colorectal cancer within 6 weeks (42 days) prior to the enrollment date.
• Have not yet initiated cancer treatment on the date of enrollment.
• Indicate intent to receive cancer treatment at the University of North Carolina.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Katie Reeder-Hayes

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Laurie-Zehr, MA

CONTACT

919-445-6199; erin_laurie@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: November 6, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)