search
Back to results

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

Primary Purpose

Cancer, Breast Cancer, Colorectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Survey
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer focused on measuring patient-reported outcome, electronic, health equity, electronic survey, treatment delay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

electronic patient-reported outcome (ePRO) questionnaires.

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06096623
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast Cancer, Colorectal Cancer
Keywords
patient-reported outcome, electronic, health equity, electronic survey, treatment delay

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electronic patient-reported outcome (ePRO) questionnaires.
Arm Type
Experimental
Arm Description
Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Weekly Survey
Intervention Description
Subjects will respond to Electronic patient-reported outcome (ePRO) every week for 8 weeks.
Primary Outcome Measure Information:
Title
Feasibility of Electronic patient-reported outcome (ePRO)
Description
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.
Time Frame
Baseline to 56 days post-enrollment
Title
Electronic patient-reported outcome (ePRO) confirming treatment initiation
Description
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.
Time Frame
Baseline to 56 days post-enrollment
Secondary Outcome Measure Information:
Title
Delayed Treatment
Description
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.
Time Frame
Baseline to 56 days post-enrollment
Title
Time to ePRO-reported treatment
Description
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.
Time Frame
Baseline to 56 days post-enrollment
Title
Proportion of treatment delay
Description
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.
Time Frame
Baseline to 56 days post-enrollment
Title
Time to treatment in days
Description
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.
Time Frame
Baseline to 180 days post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Laurie-Zehr, MA
Phone
919-445-6199
Email
erin_laurie@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Reeder-Hayes
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs