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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Transportation for Cancer Care Navigation Tool (TRACT)?

Research on patient navigation programs, which help guide cancer patients through treatment, shows they can improve therapy management, adherence to treatment, and quality of life. These programs often address barriers like transportation, suggesting that TRACT could be effective in helping patients access cancer care. ^{1 2 3 4 5}

Is the Transportation Assistance for Cancer Care program safe for humans?

The AMAFRICA study found that a similar patient navigation program improved safety for cancer patients by helping them adhere to their treatment. This suggests that programs like Transportation Assistance for Cancer Care are generally safe for humans. ^{1 2 4 6 7}

How does the transportation assistance treatment for cancer care differ from other treatments?

The transportation assistance treatment for cancer care is unique because it focuses on providing logistical support, such as transportation, to help patients access their cancer treatments. This approach is different from traditional medical treatments as it addresses practical barriers to care, improving adherence and reducing stress for patients. ^{1 2 5 8 9}

Research Team

Jinbing Bai

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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

I am mentally capable of understanding and agreeing to participate.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

2. England pubmed.ncbi.nlm.nih.gov

AMAFRICA, a patient-navigator program for accompanying lymphoma patients during chemotherapy in Ivory Coast: a prospective randomized study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021]

4. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Theory-based, Non-clinical Patient Navigator Program to Address Barriers in an Urban Cancer Center Setting. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Patient navigators improve care of cancer patients. [2008]

9. United States pubmed.ncbi.nlm.nih.gov

Negotiating Lay and Clinical Issues: Implementing a Lay Navigation Program in Cancer Care. [2021]