Trial Title:
Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy
NCT ID:
NCT06541158
Condition:
Malignant Solid Neoplasm
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Stage II Group II (usual care, video, pamphlet)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Discussion
Description:
Participate in a CAB
Arm group label:
Stage I (CAB)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive PAF pamphlet
Arm group label:
Stage II Group II (usual care, video, pamphlet)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Behavioral
Intervention name:
Health Promotion and Care
Description:
Receive the TRACT program
Arm group label:
Stage II Group I (TRACT program)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
Receive transportation awareness brief video
Arm group label:
Stage II Group II (usual care, video, pamphlet)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Stage II Group I (TRACT program)
Arm group label:
Stage II Group II (usual care, video, pamphlet)
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory Proton Therapy Center
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jinbing Bai, PhD, RN
Phone:
404-727-2466
Email:
jinbing.bai@emory.edu
Contact backup:
Last name:
Maria Norman
Phone:
404-727-2466
Email:
maria.norman@emory.edu
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jinbing Bai, PhD, RN
Phone:
404-727-2466
Email:
jinbing.bai@emory.edu
Contact backup:
Last name:
Maria Norman
Email:
maria.norman@emory.edu
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jinbing Bai, PhD, RN
Phone:
404-727-2466
Email:
jinbing.bai@emory.edu
Contact backup:
Last name:
Maria Norman
Phone:
404-727-2466
Email:
maria.norman@emory.edu
Investigator:
Last name:
Jinbing Bai
Email:
Principal Investigator
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jinbing Bai, PhD, RN
Phone:
404-727-2466
Email:
jinbing.bai@emory.edu
Contact backup:
Last name:
Maria Norman
Phone:
404-727-2466
Email:
maria.norman@emory.edu
Start date:
November 6, 2024
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541158
