Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Development of the Financial Compass intervention (Aim 1)
研究概览
简要总结
This clinical trial compares the effect a financial intervention, called Financial Compass, to usual care in identifying and addressing financial hardship in patients with head and neck cancer. Previous research has shown that head and neck cancer patients experiencing financial hardship have decreased overall and cancer specific survival. Using a financial intervention, Financial Compass, may be more effective than usual care in identifying and addressing financial hardship in patients with head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. Apply community-engaged intervention mapping to tailor the Financial Compass intervention to address the needs and experiences of head and neck cancer patients. (Aim 1) II. Conduct a pilot randomized control trial of Financial Compass to assess feasibility, acceptability and preliminary efficacy among head and neck cancer patients. (Aim 2)
OUTLINE:
AIM 1: Participants take part in a community advisory board and/or a health care delivery advisory board on study to discuss, develop and refine the Financial Compass intervention.
AIM 2: Screening questionnaire to identify financial concerns. Subjects will be randomized to :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •They have been diagnosed with head and neck cancer
- •Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure
- •Are able to participate in English or Spanish
排除标准
- •Adults unable to complete the process of informed consent
- •Adults whose primary language is not English or Spanish
- •Individuals who are not yet adults (i.e., infants, children, teenagers)
- •Unwilling or unable to follow protocol requirements
结局指标
主要结局
Development of the Financial Compass intervention (Aim 1)
时间窗: Up to 2 years
Will use stage 1A of the National Institutes of Health Stage Model to further develop the Financial Compass intervention. Will use data from in-depth interviews and collaborative engagement of advisory boards to refine the final Financial Compass intervention package. Will complete the Financial Compass intervention package. Will use the Person, Extended Family, Neighborhood (PEN)-3 model to guide integration of stakeholder feedback into the final Financial Compass intervention package. Will prepare summaries of key findings from the in-depth interviews to review with advisory board members. Themes in advisory board member feedback will be categorized using the main constructs of PEN-3 model in a 3 x 3 table, including (1) perceptions, (2) enablers, and (3) nurturers.
Feasibility of the Financial Compass intervention (Aim 2)
时间窗: Up to 12 weeks
Will assess feasibility of the Financial Compass intervention among head and neck cancer patients. Will examine feasibility through demand (study enrollment rates, reasons for refusal), practicality (retention rates, engagement with intervention sessions/materials, reasons for study drop out), and acceptability (participant satisfaction with intervention materials and content). To assess acceptability, will administer the Acceptability of Intervention Measure (4 items), Intervention Appropriateness Measure (4 items) and Feasibility of Intervention Measure (4 items). The measures use a 5-point Likert scale where 1 = completely disagree and 5 = completely agree and have demonstrated strong psychometric properties. In the Financial Compass group, the measures will be summarized using the appropriate descriptive statistics, with estimates of enrollment and retention rates obtained with 90% confidence intervals.
次要结局
未报告次要终点