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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Stage I (CAB)

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

Group Type EXPERIMENTAL

Discussion

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Health Promotion and Care

Intervention Type BEHAVIORAL

Receive the TRACT program

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stage II Group II (usual care, video, pamphlet)

Patients receive usual care with PAF pamphlet for 3 months.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Educational Intervention

Intervention Type OTHER

Receive PAF pamphlet

Media Intervention

Intervention Type OTHER

Receive transportation awareness brief video

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Discussion

Participate in a CAB

Intervention Type OTHER

Educational Intervention

Receive PAF pamphlet

Intervention Type OTHER

Health Promotion and Care

Receive the TRACT program

Intervention Type BEHAVIORAL

Media Intervention

Receive transportation awareness brief video

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Discuss Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Jinbing Bai

Jinbing Bai, PhD, RN

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status NOT_YET_RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Jinbing Bai, PhD, RN

Role: primary

404-727-2466

Maria Norman

Role: backup

404-727-2466

Jinbing Bai, PhD, RN

Role: primary

404-727-2466

Maria Norman

Role: backup

Jinbing Bai, PhD, RN

Role: primary

404-727-2466

Maria Norman

Role: backup

404-727-2466

Jinbing Bai, PhD, RN

Role: primary

404-727-2466

Maria Norman

Role: backup

404-727-2466

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

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007528

Identifier Type: -

Identifier Source: org_study_id

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