Clinical trial NCT06096623: The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer Treatment
Official title: The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparities in Cancer Treatment Delay
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Breast Cancer
Colorectal Cancer
Keywords: patient-reported outcome
electronic
health equity
electronic survey
treatment delay
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Electronic patient-reported outcome (ePRO)
timeFrame: Baseline to 56 days post-enrollment
measure: Electronic patient-reported outcome (ePRO) confirming treatment initiation
timeFrame: Baseline to 56 days post-enrollment
Secondary outcomes:
measure: Delayed Treatment
timeFrame: Baseline to 56 days post-enrollment
measure: Time to ePRO-reported treatment
timeFrame: Baseline to 56 days post-enrollment
measure: Proportion of treatment delay
timeFrame: Baseline to 56 days post-enrollment
measure: Time to treatment in days
timeFrame: Baseline to 180 days post-enrollment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Katie Reeder-Hayes
role: PRINCIPAL_INVESTIGATOR
References: