Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT06541158

Conditions

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Discussion

Educational Intervention

Health Promotion and Care

Media Intervention

Study Details

Brief 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. 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.

Conditions

Malignant Solid Neoplasm

Study ID

NCT06541158

Start date

Nov 6, 2024

Status verified date

May, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Stage I (CAB)

Participants meet with the study research team to develop and refine the TRACT program.

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.

active comparator: Stage II Group II (usual care, video, pamphlet)

Patients receive usual care with PAF pamphlet for 3 months.

Interventions

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

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) ]
  • Recruitment to the TRACT program (Feasibility) [ Time Frame: At T0 (pre-intervention) and T1 (3 months post-intervention) ]
  • Retention and adherence rate (Feasibility) [ Time Frame: At T0 (pre-intervention) and T1 (3 months post-intervention) ]
  • Acceptability of the Transportation for Cancer Care Navigation Tool [ Time Frame: At T0 (pre-intervention) and T1 (3 months post-intervention) ]
  • Travel barriers [ Time Frame: At T0 (3 months) and T1 (3 months post-intervention) ]
  • Treatment adherence [ Time Frame: At T1 (3 months post-intervention) ]
  • Distress [ Time Frame: At T0 (3 months) and T1 (3 months post-intervention) ]
  • Financial toxicity [ Time Frame: At T0 (3 months) and T1 (3 months post-intervention) ]
  • Quality of life (QOL) [ Time Frame: At T0 (3 months) and T1 (3 months post-intervention) ]

Central Contacts and Locations

Locations

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Jinbing Bai

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

More Information

Sponsor

Emory University

Last update posted

May 28, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-28.