Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541158
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing the Feasibility of a Transportation for Cancer Care Navigation Tool TRACT in Solid Tumors Patients Receiving Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACT
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
Detailed Description:
PRIMARY OBJECTIVES
I To work collaboratively with a Community Advisory Board CAB eg 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
I To work collaboratively with a Community Advisory Board CAB eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None