CancerNCT06096623
The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer Treatment
An observational study of Cancer and Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Weekly Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 5 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants intent to receive cancer treatment at the University of North Carolina.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparities in Cancer Treatment Delay
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.
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Weekly Survey
- Keywords
- patient-reported outcome, electronic, health equity, electronic survey, treatment delay
- Medical subject headings
- Neoplasms, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly SurveyBehavioural
Subjects will respond to Electronic patient-reported outcome (ePRO) every week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| electronic patient-reported outcome (ePRO) questionnaires. | Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires. Receives: Behavioral: Weekly Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 56 days post-enrollment
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 180 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start6 Nov 2023
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie Reeder-Hayes, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096623
- Sponsor's protocol ID
- LCCC2315
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparities in Cancer Treatment Delay
- ClinicalTrials.gov ID
- NCT06096623
- Acronym / sponsor ID
- LCCC2315
- Conditions
- Cancer, Breast Cancer, Colorectal Cancer
- Keywords
- patient-reported outcome, electronic, health equity, electronic survey, treatment delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electronic patient-reported outcome (ePRO) questionnaires. | – | Behavioral: Weekly SurveySubjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants intent to receive cancer treatment at the University of North Carolina.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly SurveySubjects will respond to Electronic patient-reported outcome (ePRO) every week for 8 weeks. | Behavioural | electronic patient-reported outcome (ePRO) questionnaires. |
Primary outcome
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.
4 secondary outcomes
Delayed Treatment
Time frame: Baseline to 56 days post-enrollment
Time to ePRO-reported treatment
Time frame: Baseline to 56 days post-enrollment
Proportion of treatment delay
Time frame: Baseline to 56 days post-enrollment
Time to treatment in days
Time frame: Baseline to 180 days post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Reeder-Hayes principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Electronic patient-reported outcome (ePRO) (time frame: Baseline to 56 days post-enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.