Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy (TRACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Discussion; Behavioral: Health Promotion and Care; Other: Educational Intervention; Other: Media Intervention

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Contact: Jinbing Bai, PhD, RN; Phone Number: 404-727-2466; Email: jinbing.bai@emory.edu
      • Principal Investigator: Jinbing Bai
      • Contact: Maria Norman; Phone Number: 404-727-2466; Email: maria.norman@emory.edu
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
      • Contact: Maria Norman; Email: maria.norman@emory.edu
      • Contact: Jinbing Bai, PhD, RN; Phone Number: 404-727-2466; Email: jinbing.bai@emory.edu
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Emory Saint Joseph's Hospital
      • Contact: Jinbing Bai, PhD, RN; Phone Number: 404-727-2466; Email: jinbing.bai@emory.edu
      • Contact: Maria Norman; Phone Number: 404-727-2466; Email: maria.norman@emory.edu
    • Atlanta, Georgia, United States, 30308
      • Not yet recruiting
      • Emory Proton Therapy Center
      • Contact: Jinbing Bai, PhD, RN; Phone Number: 404-727-2466; Email: jinbing.bai@emory.edu
      • Contact: Maria Norman; Phone Number: 404-727-2466; Email: maria.norman@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage I (CAB); Participants meet with the study research team to develop and refine the TRACT program.	Other: Discussion; Participate in a CAB; Other Names: Discuss
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Health Promotion and Care; Receive the TRACT program
Active Comparator: Stage II Group II (usual care, video, pamphlet); Patients receive usual care with PAF pamphlet for 3 months.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive PAF pamphlet; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Media Intervention; Receive transportation awareness brief video

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At T0 (pre-intervention) and 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.	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.	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.	At T0 (3 months) 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.	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.	At T1 (3 months post-intervention)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jinbing Bai, Emory University Hospital/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Quality of Health Care; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Health Education; Methods; Standard of Care; Early Intervention, Educational; Educational Status; Practice Guidelines as Topic; Health Promotion
• Other Study ID Numbers: STUDY00007528; P30CA138292 (U.S. NIH Grant/Contract); NCI-2024-05756 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); WINSHIP6207-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No