Transportation Assistance for Cancer Care

(TRACT Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Palliative care, Non-English, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called TRACT, designed to assist cancer patients who struggle to attend their radiation therapy appointments. The goal is to determine if this program can ease travel to treatments, potentially improving overall health outcomes. The trial includes different groups: one receives usual care with some educational materials, while the other uses the TRACT program, which provides personalized transportation assistance. It seeks patients with solid tumors who are currently undergoing radiation therapy and have difficulty reaching their treatment appointments. As an unphased trial, this study offers a unique opportunity for patients to contribute to research that could improve access to essential cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on addressing travel barriers for cancer care.

What prior data suggests that the Transportation for Cancer Care Navigation Tool (TRACT) is safe for patients with solid tumors receiving radiation therapy?

Research has shown that the Transportation for Cancer Care Navigation Tool (TRACT) aids cancer patients by simplifying travel to appointments. Since this trial focuses on a tool rather than a drug or medical treatment, safety concerns are minimal. No reports of problems have emerged from using the TRACT tool. By facilitating easier access to appointments, it can enhance treatment outcomes. Overall, TRACT has been well-received, and previous studies or uses have identified no safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transportation for Cancer Care Navigation Tool (TRACT) because it tackles a major barrier for cancer patients: getting to treatment appointments. Unlike standard options that might provide generic information or rely on patients to find their own way, TRACT actively screens for travel barriers and provides tailored assistance. The program uses videos to raise awareness about transportation resources and employs a trained travel navigator to align community resources for personalized support. This hands-on, individualized approach could significantly improve access to cancer care, making a real difference in treatment adherence and outcomes.

What evidence suggests that the Transportation for Cancer Care Navigation Tool (TRACT) is effective in reducing travel barriers for cancer patients?

Research has shown that many cancer patients struggle to travel to treatment centers, particularly for radiation therapy, which often requires daily visits over several weeks. This trial evaluates the Transportation for Cancer Care Navigation Tool (TRACT) to address these travel challenges. Participants in the Stage II Group I arm will receive the TRACT program, which includes screening for travel barriers, raising awareness of transportation obstacles and resources, assisting with transportation resource application and utilization, and aligning community resources. Early results suggest that programs like TRACT can slightly reduce emergency room visits and unexpected hospital stays for patients who use them. By helping patients find and use transportation options, TRACT could improve adherence to treatment plans and overall health. Addressing these travel problems is crucial because they can negatively affect the success of cancer treatment and the quality of life for patients. ^{2 3 4 5 6}

Who Is on the Research Team?

Jinbing Bai

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with solid tumors who are undergoing radiation therapy and face travel barriers to receive their treatment. It aims to help those who struggle with getting to their appointments due to transportation issues.

Inclusion Criteria

I have been diagnosed with a solid tumor.

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

Non-English-speaking (excluded due to pilot data without fund to support translation services)

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage I (CAB)

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

4 weeks

1 visit (in-person)

Stage II (Treatment)

Patients receive either the TRACT program or usual care with PAF pamphlet for 3 months

12 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Transportation for Cancer Care Navigation Tool (TRACT)

Trial Overview The study tests the Transportation for Cancer Care Navigation Tool (TRACT), designed to ease travel difficulties for cancer patients receiving radiation therapy. The goal is to see if TRACT can improve adherence to treatment schedules and overall health outcomes.

How Is the Trial Designed?

Group I: Stage II Group I (TRACT program) Experimental Treatment 2 Interventions

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: Stage I (CAB) Experimental Treatment 1 Intervention

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

Group III: Stage II Group II (usual care, video, pamphlet) Active Control 4 Interventions

Patients receive usual care with PAF pamphlet for 3 months.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Rochester Patient Navigation Research Program is a randomized clinical trial involving 344 newly-diagnosed breast and colorectal cancer patients, aiming to reduce health disparities by combining patient navigation and communication coaching.

The intervention provides tailored support from trained navigators to improve patients' access to care, adherence, and overall satisfaction, potentially leading to better health outcomes and self-efficacy in managing their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities. Hendren, S., Griggs, JJ., Epstein, RM., et al.[2022]

Cancer patient navigators, trained by the American Cancer Society, help newly diagnosed patients understand their treatment options and reduce confusion.

The program assesses patient distress levels to make tailored referrals, ensuring that patients receive the most appropriate support for their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigators improve care of cancer patients. [2008]

The implementation of the Ambulatory Medical Assistance (AMA) program for malignant lymphoma patients in Ivory Coast significantly reduced treatment refusal and abandonment compared to a control group, indicating its feasibility and potential benefits in low-middle income countries.

Despite the positive impact on adherence, only one third of patients completed their chemotherapy, and there were no significant differences in treatment outcomes like complete response rate or overall survival, primarily due to financial limitations affecting access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study. Koffi, KG., Silué, DA., Laurent, C., et al.[2020]

Oncology nurse navigation programs significantly reduced the time from the first provider visit to the start of therapy for patients with hematologic malignancies, improving access to care.

Patient and provider satisfaction scores were high regarding the navigation program, although it did not lead to an increase in clinical trial enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . Gordils-Perez, J., Schneider, SM., Gabel, M., et al.[2018]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., et al.[2021]

Lay navigation programs in cancer care face significant implementation challenges, including supportive care concerns and scheduling issues, as identified through a mixed methods study at a comprehensive cancer center involving 12 tumor-specific clinics.

Effective navigation requires extensive, ongoing effort to build knowledge and relationships within clinical teams, highlighting the need for better integration of lay navigators with clinical staff to enhance patient care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negotiating Lay and Clinical Issues: Implementing a Lay Navigation Program in Cancer Care. Holdsworth, LM., Zionts, D., Wang, S., et al.[2021]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

The Pennsylvania Patient Navigator Demonstration Project (PaPND) involved 44 cancer patients and showed that a culturally and linguistically appropriate navigation program effectively helped patients overcome barriers like transportation and insurance, which were the most common issues faced.

Participants reported improvements in stress-related thoughts, understanding of their disease, and self-efficacy in managing cancer-related issues after receiving navigation services, highlighting the importance of integrating non-clinical support with clinical care for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Theory-based, Non-clinical Patient Navigator Program to Address Barriers in an Urban Cancer Center Setting. Fleisher, L., Miller, SM., Crookes, D., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06541158

Transportation for Cancer Care Navigation Tool ... This clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors ...

2. trialx.com trialx.com/clinical-trials/listings/296509/transportation-for-cancer-care-navigation-tool-for-reducing-travel-barriers-among-patients-with-solid-tumors-receiving-radiation-therapy/

Transportation for Cancer Care Navigation Tool ... It is estimated that 20-30% patients with cancer experience travel-related barriers for cancer care. This is a particular problem for patients ...

3. withpower.com withpower.com/trial/phase-malignant-solid-neoplasms-7-2024-e7205

Transportation Assistance for Cancer Care (TRACT Trial) The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9745432/

Addressing Transportation Insecurity Among Patients With ... As a result of transportation insecurity, patients with cancer may forego, miss, delay, alter, and/or prematurely terminate necessary care.

5. clinconnect.io clinconnect.io/trials/NCT06541158

Transportation for Cancer Care Navigation Tool for This clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06541158

Transportation for Cancer Care Navigation Tool ... This clinical trial evaluates whether the Transportation for Cancer Care Navigation Tool (TRACT) can reduce travel barriers among patients with solid tumors ...