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

NCT06541158 | Recruiting

• 4 other identifiers: STUDY00007528NCI-2024-05756WINSHIP6207-24P30CA138292
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

Study Arms (3)

Stage I (CAB)

EXPERIMENTAL

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

Other: Discussion

Stage II Group I (TRACT program)

EXPERIMENTAL

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.

Behavioral: Health Promotion and Care; Other: Questionnaire Administration

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

ACTIVE COMPARATOR

Patients receive usual care with PAF pamphlet for 3 months.

Other: Best Practice; Other: Educational Intervention; Other: Media Intervention; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

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

Discussion OTHER

Participate in a CAB

Also known as: Discuss

Stage I (CAB)

Educational Intervention OTHER

Receive PAF pamphlet

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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

Health Promotion and Care BEHAVIORAL

Receive the TRACT program

Stage II Group I (TRACT program)

Media Intervention OTHER

Receive transportation awareness brief video

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

Questionnaire Administration OTHER

Ancillary studies

Stage II Group I (TRACT program); Stage II Group II (usual care, video, pamphlet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

NOT YET RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Health Promotion

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Health Education

Study Officials

• Jinbing Bai

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jinbing Bai, PhD, RN

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (4)