Malignant Solid NeoplasmTRACTNCT06541158
Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy
A study testing Best Practice, Discussion and Educational Intervention in people with Malignant Solid Neoplasm, run by Emory University at 4 sites in United States.
Trial summary
This clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors receiving radiation therapy. It is estimated that 20-30% patients with cancer experience travel-related barriers for cancer care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm
- What is being tested?
- Best Practice, Discussion and Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Nov 2024to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years
- Diagnosed with solid tumors
- Undergoing RT (not excluded with chemotherapy)
- Competent to give consent
- English-speaking
- With travel barriers as screened by the reliable and validated 10-item Transportation Barriers Measure. In this study, item 2 ("how much trouble is it for you to get transportation to your doctor or treatment?") from the general barriers domain will be used to screen patients for travel barriers
Who cannot join
- Receive palliative care
- Are non-English-speaking (excluded due to pilot data without fund to support translation services)
- Are enrolled in lodging programs (e.g., the American Cancer Society [ACS] Hope Lodge®)
- Have major depression/anxiety disorders that interfere with their ability to participate (based on the electronic medical records report)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Jinbing Bai, PhD, RN, 404-727-2466, jinbing.bai@emory.edu
Maria Norman, 404-727-2466, maria.norman@emory.edu
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Jinbing Bai, PhD, RN, 404-727-2466, jinbing.bai@emory.edu
Maria Norman, maria.norman@emory.edu
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Jinbing Bai, PhD, RN, 404-727-2466, jinbing.bai@emory.edu
Maria Norman, 404-727-2466, maria.norman@emory.edu
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Jinbing Bai, PhD, RN, 404-727-2466, jinbing.bai@emory.edu
Maria Norman, 404-727-2466, maria.norman@emory.edu
About this study
Official title: Testing the Feasibility of a Transportation for Cancer Care Navigation Tool (TRACT) in Solid Tumors Patients Receiving Radiotherapy
This clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors receiving radiation therapy. It is estimated that 20-30% patients with cancer experience travel-related barriers for cancer care. This is a particular problem for patients with radiation therapy as these patients frequently receive multiple treatment cycles, which often require daily treatment for multiple weeks or months. Addressing travel barriers has been a prerequisite for cancer care as travel barriers negatively influence cancer treatment adherence and cancer care outcomes, such as survival and quality of life. The TRACT program may help reduce travel barriers and therefore promote health equity among patients with solid tumors receiving radiation therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- To work collaboratively with a Community Advisory Board (CAB, e.g., patients, caregivers, clinicians, and social workers) to refine a theory-driven TRACT program for solid tumor patients receiving radiation therapy (RT) with travel barriers.
II. To evaluate the feasibility of the TRACT program for patients with solid tumors receiving RT with travel barriers.
III. To explore the efficacy of the TRACT program on RT adherence (canceling, delaying, missing, or terminating essential care) and patient-reported outcomes (PROs) (distress, financial toxicity, and quality of life [QOL]) compared to enhanced usual care (EUC, usual care + transportation awareness brief video with Patient Advocate Foundation [PAF] pamphlet).
OUTLINE:
STAGE I (CAB): Participants meet with the study research team to develop and refine the TRACT program.
STAGE II: Patients are randomized to 2 groups.
GROUP I: Patients receive the TRACT program consisting: of 1) Screening of travel barriers; 2) Awareness of transportation obstacles and resources using videos, 3) Assistance with transportation resource application and utilization, and 4) Alignment of community resources to navigate individualized transportation support by the trained travel navigator for 3 months.
GROUP II: Patients receive usual care with PAF pamphlet for 3 months.
After completion of study intervention, patients are followed up at 3 months.
- Conditions
- Malignant Solid Neoplasm
- Being tested
- Best Practice, Discussion, Educational Intervention, Health Promotion and Care, Media Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
DiscussionOther
Also called Discuss
Participate in a CAB
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive PAF pamphlet
Health Promotion and CareBehavioural
Receive the TRACT program
Media InterventionOther
Receive transportation awareness brief video
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Stage I (CAB) | Experimental | Participants meet with the study research team to develop and refine the TRACT program. Receives: Other: Discussion |
| Stage II Group I (TRACT program) | Experimental | Patients receive the TRACT program consisting: of 1) Screening of travel barriers; 2) Awareness of transportation obstacles and resources using videos, 3) Assistance with transportation resource application and utilization, and 4) Alignment of community resources to navigate individualized transportation support by the trained travel navigator for 3 months. Receives: Behavioral: Health Promotion and Care; Other: Questionnaire Administration |
| Stage II Group II (usual care, video, pamphlet) | Active comparator | Patients receive usual care with PAF pamphlet for 3 months. Receives: Other: Best Practice; Other: Educational Intervention; Other: Media Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) program
Will be assessed by response rates, time burden (minutes to complete the measure), and percent of positive screenings. Will use descriptive statistics. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Measured: At T0 (pre-intervention) and T1 (3 months post-intervention)
Recruitment to the TRACT program (Feasibility)
Will be assessed by the number of patients screened and randomized. Will use descriptive statistics. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Measured: At T0 (pre-intervention) and T1 (3 months post-intervention)
Retention and adherence rate (Feasibility)
Will be assessed by the total number of meetings and time spent with the travel navigator for travel resources, percentage of patients using travel resources, percentage of patients with completed measures. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Measured: At T0 (pre-intervention) and T1 (3 months post-intervention)
Acceptability of the Transportation for Cancer Care Navigation Tool
Will be assessed by the 4-item Acceptability of Intervention Measure with Cronbach alpha=0.85-0.91. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Measured: At T0 (pre-intervention) and T1 (3 months post-intervention)
Travel barriers
Will be reported as transportation mode (e.g., public transportation, drive-myself, drive-someone else drives me), owning a car (yes/no), parking cost, and travel cost for each appointment. Travel distance and time to cancer treatment facilities will be estimated by ArcGIS 10.3. Categorical and continuous variables will be used to present this outcome variable.
Measured: At T0 (3 months) and T1 (3 months post-intervention)
Treatment adherence
Will be assessed by canceling, missing, delaying, or terminating essential care. Nonadherence rates will be calculated as the number of no-shows, same-day cancellations, delays, and early stoppage of treatment divided by the total number of treatment days based on data within the electronic health records (EMRs). A percentage of completion rate of treatment will be calculated to present the treatment adherence.
Measured: At T1 (3 months post-intervention)
Distress
Will be measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer. The one-item 11-point Likert scale represented on a visual graphic of a thermometer ranging from 0 (no distress) to 10 (extreme distress) will be used to assess patients' distress. Will be assessed using mixed-effect analysis of variance to model the correlations.
Measured: At T0 (3 months) and T1 (3 months post-intervention)
Financial toxicity
Will be measured by the Comprehensive Score for Financial Toxicity (COST). The COST is a 5-point Likert scale evaluating financial toxicity in the past week. Will be assessed using mixed-effect analysis of variance to model the correlations.
Measured: At T0 (3 months) and T1 (3 months post-intervention)
Quality of life (QOL)
Will be measured by the European QoL 5-Dimension questionnaire (EQ-5D), a widely used instrument to measure patients' QOL. The EQ-5D is a 2-part questionnaire. Will be calculated based on the technique of composite time trade-off preferences and scores of the 5 domains, indicating that -0.573 = worst health and 1 = best health. Will be assessed using mixed-effect analysis of variance to model the correlations.
Measured: At T0 (3 months) and T1 (3 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start6 Nov 2024
- Primary completion15 May 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jinbing Bai, Emory University
- Investigators
- Jinbing Bai, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541158
- Sponsor's protocol ID
- STUDY00007528
- Other IDs
- NCI-2024-05756, STUDY00007528, WINSHIP6207-24, P30CA138292
- Acronym
- TRACT
- Status last verified
- May 2026
- First submitted
- 2 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Transportation for Cancer Care Navigation Tool (TRACT) in Solid Tumors Patients Receiving Radiotherapy
- ClinicalTrials.gov ID
- NCT06541158
- Acronym / sponsor ID
- TRACT / STUDY00007528
- Conditions
- Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 7 Aug 2024 (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 clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors receiving radiation therapy. It is estimated that 20-30% patients with cancer experience travel-related barriers for cancer care. This is a particular problem for patients with radiation therapy as these patients frequently receive multiple treatment cycles, which often require daily treatment for multiple weeks or months. Addressing travel barriers has been a prerequisite for cancer care as travel barriers negatively influence cancer treatment adherence and cancer care outcomes, such as survival and quality of life. The TRACT program may help reduce travel barriers and therefore promote health equity among patients with solid tumors receiving radiation therapy.
Detailed description
PRIMARY OBJECTIVES:
- To work collaboratively with a Community Advisory Board (CAB, e.g., patients, caregivers, clinicians, and social workers) to refine a theory-driven TRACT program for solid tumor patients receiving radiation therapy (RT) with travel barriers.
II. To evaluate the feasibility of the TRACT program for patients with solid tumors receiving RT with travel barriers.
III. To explore the efficacy of the TRACT program on RT adherence (canceling, delaying, missing, or terminating essential care) and patient-reported outcomes (PROs) (distress, financial toxicity, and quality of life [QOL]) compared to enhanced usual care (EUC, usual care + transportation awareness brief video with Patient Advocate Foundation [PAF] pamphlet).
OUTLINE:
STAGE I (CAB): Participants meet with the study research team to develop and refine the TRACT program.
STAGE II: Patients are randomized to 2 groups.
GROUP I: Patients receive the TRACT program consisting: of 1) Screening of travel barriers; 2) Awareness of transportation obstacles and resources using videos, 3) Assistance with transportation resource application and utilization, and 4) Alignment of community resources to navigate individualized transportation support by the trained travel navigator for 3 months.
GROUP II: Patients receive usual care with PAF pamphlet for 3 months.
After completion of study intervention, patients are followed up at 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage I (CAB) | Experimental | Other: DiscussionParticipants meet with the study research team to develop and refine the TRACT program. |
| Stage II Group I (TRACT program) | Experimental | Behavioral: Health Promotion and Care, Other: Questionnaire AdministrationPatients receive the TRACT program consisting: of 1) Screening of travel barriers; 2) Awareness of transportation obstacles and resources using videos, 3) Assistance with transportation resource application and utilization, and 4) Alignment of community resources to navigate individualized transportation support by the trained travel navigator for 3 months. |
| Stage II Group II (usual care, video, pamphlet) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Media Intervention, Other: Questionnaire AdministrationPatients receive usual care with PAF pamphlet for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diagnosed with solid tumors
- Undergoing RT (not excluded with chemotherapy)
- Competent to give consent
- English-speaking
Key exclusion criteria (4 listed)
- Receive palliative care
- Are non-English-speaking (excluded due to pilot data without fund to support translation services)
- Are enrolled in lodging programs (e.g., the American Cancer Society [ACS] Hope Lodge®)
- Have major depression/anxiety disorders that interfere with their ability to participate (based on the electronic medical records report)
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Stage II Group II (usual care, video, pamphlet) |
| DiscussionAlso: DiscussParticipate in a CAB | Other | Stage I (CAB) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive PAF pamphlet | Other | Stage II Group II (usual care, video, pamphlet) |
| Health Promotion and CareReceive the TRACT program | Behavioural | Stage II Group I (TRACT program) |
| Media InterventionReceive transportation awareness brief video | Other | Stage II Group II (usual care, video, pamphlet) |
| Questionnaire AdministrationAncillary studies | Other | Stage II Group I (TRACT program), Stage II Group II (usual care, video, pamphlet) |
Primary outcome
Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) program
Time frame: At T0 (pre-intervention) and T1 (3 months post-intervention)
Will be assessed by response rates, time burden (minutes to complete the measure), and percent of positive screenings. Will use descriptive statistics. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Recruitment to the TRACT program (Feasibility)
Time frame: At T0 (pre-intervention) and T1 (3 months post-intervention)
Will be assessed by the number of patients screened and randomized. Will use descriptive statistics. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Retention and adherence rate (Feasibility)
Time frame: At T0 (pre-intervention) and T1 (3 months post-intervention)
Will be assessed by the total number of meetings and time spent with the travel navigator for travel resources, percentage of patients using travel resources, percentage of patients with completed measures. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Acceptability of the Transportation for Cancer Care Navigation Tool
Time frame: At T0 (pre-intervention) and T1 (3 months post-intervention)
Will be assessed by the 4-item Acceptability of Intervention Measure with Cronbach alpha=0.85-0.91. Differences between the two groups will be assessed by an independent two-sample t-test or Chi-squared test if applicable. A 95% level of statistical confidence will be assumed.
Travel barriers
Time frame: At T0 (3 months) and T1 (3 months post-intervention)
Will be reported as transportation mode (e.g., public transportation, drive-myself, drive-someone else drives me), owning a car (yes/no), parking cost, and travel cost for each appointment. Travel distance and time to cancer treatment facilities will be estimated by ArcGIS 10.3. Categorical and continuous variables will be used to present this outcome variable.
Treatment adherence
Time frame: At T1 (3 months post-intervention)
Will be assessed by canceling, missing, delaying, or terminating essential care. Nonadherence rates will be calculated as the number of no-shows, same-day cancellations, delays, and early stoppage of treatment divided by the total number of treatment days based on data within the electronic health records (EMRs). A percentage of completion rate of treatment will be calculated to present the treatment adherence.
Distress
Time frame: At T0 (3 months) and T1 (3 months post-intervention)
Will be measured by the National Comprehensive Cancer Network (NCCN) Distress Thermometer. The one-item 11-point Likert scale represented on a visual graphic of a thermometer ranging from 0 (no distress) to 10 (extreme distress) will be used to assess patients' distress. Will be assessed using mixed-effect analysis of variance to model the correlations.
Financial toxicity
Time frame: At T0 (3 months) and T1 (3 months post-intervention)
Will be measured by the Comprehensive Score for Financial Toxicity (COST). The COST is a 5-point Likert scale evaluating financial toxicity in the past week. Will be assessed using mixed-effect analysis of variance to model the correlations.
Quality of life (QOL)
Time frame: At T0 (3 months) and T1 (3 months post-intervention)
Will be measured by the European QoL 5-Dimension questionnaire (EQ-5D), a widely used instrument to measure patients' QOL. The EQ-5D is a 2-part questionnaire. Will be calculated based on the technique of composite time trade-off preferences and scores of the 5 domains, indicating that -0.573 = worst health and 1 = best health. Will be assessed using mixed-effect analysis of variance to model the correlations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Related trials for Malignant Solid Neoplasm
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Jinbing Bai principal investigator
Emory University Hospital/Winship Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Discussion and Educational Intervention in people with Malignant Solid Neoplasm, run by Emory University at 4 sites 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 6 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) program (time frame: At T0 (pre-intervention) and T1 (3 months post-intervention)). The study lists 9 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 28 May 2026.