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

NCT ID: NCT06096623

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Breast Cancer Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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electronic patient-reported outcome (ePRO) questionnaires.

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

Group Type EXPERIMENTAL

Weekly Survey

Intervention Type BEHAVIORAL

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

Interventions

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Weekly Survey

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Reeder-Hayes

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Laurie-Zehr, MA

Role: CONTACT

919-445-6199

Facility Contacts

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Erin Laurie-Zehr, MA

Role: primary

919-445-6199

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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LCCC2315

Identifier Type: -

Identifier Source: org_study_id

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