Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy
NCT ID: NCT06541158
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2024-11-06
2027-02-28
Brief Summary
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Detailed Description
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I. 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Stage I (CAB)
Participants meet with the study research team to develop and refine the TRACT program.
Discussion
Participate in a CAB
Stage II Group I (TRACT program)
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.
Health Promotion and Care
Receive the TRACT program
Questionnaire Administration
Ancillary studies
Stage II Group II (usual care, video, pamphlet)
Patients receive usual care with PAF pamphlet for 3 months.
Best Practice
Receive usual care
Educational Intervention
Receive PAF pamphlet
Media Intervention
Receive transportation awareness brief video
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Discussion
Participate in a CAB
Educational Intervention
Receive PAF pamphlet
Health Promotion and Care
Receive the TRACT program
Media Intervention
Receive transportation awareness brief video
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Jinbing Bai
Jinbing Bai, PhD, RN
Principal Investigators
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Jinbing Bai
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory Proton Therapy Center
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2024-05756
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00007528
Identifier Type: -
Identifier Source: secondary_id
WINSHIP6207-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00007528
Identifier Type: -
Identifier Source: org_study_id
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