Transportation for Cancer Care Navigation Tool (TRACT) for Radiation Therapy Patients
This study is looking at whether a program called the Transportation for Cancer Care Navigation Tool (TRACT) can help patients with solid tumors who are receiving radiation therapy (RT) overcome travel challenges. Many cancer patients face difficulties getting to their appointments, especially those needing frequent radiation treatments. The TRACT program aims to reduce these travel barriers, which can negatively impact treatment success and quality of life. You might be able to join if you are at least 18 years old, have a solid tumor, are undergoing radiation therapy, speak English, and have travel difficulties. The study will measure how practical it is to screen patients for TRACT, how many people join, and how well they stick with the program. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 76 participants. It involves two stages: first, working with a Community Advisory Board, then participants are randomized into two groups.
- What's involved
- Participants in Stage I will meet with the research team. Participants in Stage II will receive either the TRACT program or usual care with a pamphlet for 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at the start of the study and 3 months after the intervention begins.
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Transportation for Cancer Care Navigation Tool for Reducing Travel Barriers Among Patients With Solid Tumors Receiving Radiation Therapy
At a glance
Conditions
NCT06541158
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Emory Proton Therapy Center
Atlanta, Georgiastudy coordinator listed
Not yet recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital Midtown
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jinbing Bai · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute
Who to contact
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Inclusion
Exclusion
What this trial measures
- Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) programAt T0 (pre-intervention) and T1 (3 months post-intervention)
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.
- Recruitment to the TRACT program (Feasibility)At T0 (pre-intervention) and T1 (3 months post-intervention)
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.
- Retention and adherence rate (Feasibility)At T0 (pre-intervention) and T1 (3 months post-intervention)
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.
- Acceptability of the Transportation for Cancer Care Navigation ToolAt T0 (pre-intervention) and T1 (3 months post-intervention)
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.
- Travel barriersAt T0 (3 months) and T1 (3 months post-intervention)
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.
- Treatment adherenceAt T1 (3 months post-intervention)
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.
- DistressAt T0 (3 months) and T1 (3 months post-intervention)
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.
- Financial toxicityAt T0 (3 months) and T1 (3 months post-intervention)
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.
- Quality of life (QOL)At T0 (3 months) and T1 (3 months post-intervention)
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.