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

Official title

Testing the Feasibility of a Transportation for Cancer Care Navigation Tool (TRACT) in Solid Tumors Patients Receiving Radiotherapy

Overview

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:

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.

Interventions

• Other Best Practice
  Receive usual care
• Other Discussion
  Participate in a CAB
• Other Educational Intervention
  Receive PAF pamphlet
• Behavioral Health Promotion and Care
  Receive the TRACT program
• Other Media Intervention
  Receive transportation awareness brief video
• Other Questionnaire Administration
  Ancillary studies

Primary outcome measures

• 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Emory Proton Therapy Center — Atlanta
• Emory University Hospital Midtown — Atlanta
• Emory University Hospital/Winship Cancer Institute — Atlanta
• Emory Saint Joseph's Hospital — Atlanta

Identifiers

NCT: NCT06541158 · STUDY00007528 · NCI-2024-05756 · STUDY00007528 · WINSHIP6207-24 · P30CA138292

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗