Testing the Feasibility of a Transportation for Cancer Care Navigation Tool (TRACT) in Solid Tumors Patients Receiving Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Acceptability of the Transportation for Cancer Care Navigation Tool
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Stage II Group II (usual care, video, pamphlet)
Patients receive usual care with PAF pamphlet for 3 months.
干预措施: Questionnaire Administration (Other)
Stage II Group II (usual care, video, pamphlet)
Patients receive usual care with PAF pamphlet for 3 months.
干预措施: Best Practice (Other)
Stage I (CAB)
Participants meet with the study research team to develop and refine the TRACT program.
干预措施: Discussion (Other)
Stage II Group I (TRACT program)
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.
干预措施: Health Promotion and Care (Behavioral)
Stage II Group I (TRACT program)
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.
干预措施: Questionnaire Administration (Other)
Stage II Group II (usual care, video, pamphlet)
Patients receive usual care with PAF pamphlet for 3 months.
干预措施: Educational Intervention (Other)
Stage II Group II (usual care, video, pamphlet)
Patients receive usual care with PAF pamphlet for 3 months.
干预措施: Media Intervention (Other)
结局指标
主要结局
Acceptability of the Transportation for Cancer Care Navigation Tool
时间窗: At 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.
Distress
时间窗: At 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.
Quality of life (QOL)
时间窗: 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.
Financial toxicity
时间窗: At 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.
Recruitment to the TRACT program (Feasibility)
时间窗: 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.
Travel barriers
时间窗: At 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.
Feasibility of screening patients for the Transportation for Cancer Care Navigation Tool (TRACT) program
时间窗: At 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.
Retention and adherence rate (Feasibility)
时间窗: 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.
Treatment adherence
时间窗: At 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.
次要结局
未报告次要终点
研究者
Jinbing Bai
Jinbing Bai, PhD, RN
Emory University