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

Study 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.

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

Conditions
-----------------
Cancer, Breast Cancer, Colorectal Cancer

Intervention / Treatment
-----------------
* Behavioral: Weekly Survey


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed Treatment | 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 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 | 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient-reported outcome, electronic, health equity, electronic survey, treatment delay