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Clinical Trials/NCT06096623
NCT06096623
Recruiting
N/A

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

UNC Lineberger Comprehensive Cancer Center1 site in 1 country240 target enrollmentNovember 6, 2023

Overview

Phase
N/A
Intervention
Weekly Survey
Conditions
Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
240
Locations
1
Primary Endpoint
Feasibility of Electronic patient-reported outcome (ePRO)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2023
End Date
May 1, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

electronic patient-reported outcome (ePRO) questionnaires.

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

Intervention: Weekly Survey

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Proportion of treatment delay(Baseline to 56 days post-enrollment)
  • Delayed Treatment(Baseline to 56 days post-enrollment)
  • Time to ePRO-reported treatment(Baseline to 56 days post-enrollment)
  • Time to treatment in days(Baseline to 180 days post-enrollment)

Study Sites (1)

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