Clinical trial NCT06541158: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Solid Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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)

Primary outcomes:
measure: Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) program
timeFrame: At T0 (pre-intervention) and T1 (3 months post-intervention)
measure: Recruitment to the TRACT program (Feasibility)
timeFrame: At T0 (pre-intervention) and T1 (3 months post-intervention)
measure: Retention and adherence rate (Feasibility)
timeFrame: At T0 (pre-intervention) and T1 (3 months post-intervention)
measure: Acceptability of the Transportation for Cancer Care Navigation Tool
timeFrame: At T0 (pre-intervention) and T1 (3 months post-intervention)
measure: Travel barriers
timeFrame: At T0 (3 months) and T1 (3 months post-intervention)
measure: Treatment adherence
timeFrame: At T1 (3 months post-intervention)
measure: Distress
timeFrame: At T0 (3 months) and T1 (3 months post-intervention)
measure: Financial toxicity
timeFrame: At T0 (3 months) and T1 (3 months post-intervention)
measure: Quality of life (QOL)
timeFrame: At T0 (3 months) and T1 (3 months post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Proton Therapy Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Jinbing Bai
role: PRINCIPAL_INVESTIGATOR
References: