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Trial Title:
The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer Treatment
NCT ID:
NCT06096623
Condition:
Cancer
Breast Cancer
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
patient-reported outcome
electronic
health equity
electronic survey
treatment delay
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Weekly Survey
Description:
Subjects will respond to Electronic patient-reported outcome (ePRO) every week for 8
weeks.
Arm group label:
electronic patient-reported outcome (ePRO) questionnaires.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Laurie-Zehr, MA
Phone:
919-445-6199
Email:
erin_laurie@med.unc.edu
Investigator:
Last name:
Katie Reeder-Hayes, MD
Email:
Principal Investigator
Start date:
November 6, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096623
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
