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临床试验/NCT07409662
NCT07409662已完成不适用

Coverage and Cost of Care Links- Telehealth

Jean Edward1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年3月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
试验地点
1
主要终点
Program Acceptability

研究概览

简要总结

The overall objective of this study is to develop and implement CC LinksTele (Coverage and Cost-of-Care Links- Telehealth)- a multilevel intervention designed to empower pediatric cancer patients, caregivers, and healthcare teams with the resources to reduce financial toxicity by addressing patient and caregiver financial health literacy (individual-level) and cancer care delivery pathways and workflows to address financial hardship (health system-level).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving or have received services at Danceblue clinic
  • adult patient with pediatric cancer diagnosis
  • caregiver of pediatric patient with cancer diagnosis

排除标准

  • - unable to provide consent

研究组 & 干预措施

CC LinksTele- Patient and Caregiver

Experimental

caregivers of children with any cancer diagnosis and young adults with childhood cancers

干预措施: CC LinksTele (Other)

结局指标

主要结局

Program Acceptability

时间窗: Approximately 8 months (baseline and following resolution of financial needs)

Acceptability will be measured as mean post-intervention ratings of greater than 7-10 on financial navigation program relevance, helpfulness, convenience, recommendation to others and value (0=not at all to 10=extremely). Higher scores indicate greater program acceptability.

Change in psychological response (financial toxicity)

时间窗: Approximately 8 months (baseline and following resolution of financial needs)

Psychological response (i.e. financial toxicity) was measured using the 11-item Comprehensive Score for Financial Toxicity (COST) that measures emotional aspects of financial hardship (financial toxicity) among cancer patients. Each item is scored on a 5-point ordinal scale ranging from 0='Not at all' to 4='Very much.' Sample items include 'My out-of-pocket expense are more than I thought they would be' and 'I am frustrated that I cannot work or contribute as much as I usually do.' Lower values indicate greater financial toxicity.

Change in health-related quality of life

时间窗: Approximately 8 months (baseline and following resolution of financial needs)

Health-related QOL was measured using four Patient-Reported Outcomes Measurement Information System (PROMIS) scales.xx Each of these were scored and standardized by submitting the raw values to the HealthMeasures scoring service. standardized values of the total scores were used throughout the analysis for this study. The four scales include the PROMIS physical health and emotional health subscales (from the 10-item PROMIS Scale v1.2 - Global Health),xx the 4-item PROMIS- Anxiety Short Form, and the 6-item PROMIS-Depression Short Form. The physical (physical health, function, pain, and fatigue items) and emotional health (QOL, mental health, social activities, and emotional problem items) subscales are each based on 4 items, with higher scores indicating a more positive health self-assessment. For the anxiety and depression scales, higher scores indicate a greater manifestation of symptoms.

Change in distress.

时间窗: Approximately 8 months (baseline and following resolution of financial needs)

Distress was measured using the National Comprehensive Cancer Network's (NCCN) Distress Thermometer and its accompanying 40-item problem list. A cutoff score of 4 indicated clinically elevated distress levels

Change in health insurance literacy

时间窗: Approximately 8 months (baseline and following resolution of financial needs)

single item, yes/no question "Did you ever have a problem understanding health insurance or medical bills related to your cancer, its treatment, or the lasting effects of that treatment?"

Program Feasibility

时间窗: 8 months

Feasibility will be measured using the entire sample of program participants and will be defined by number enrolled

Program Adherence

时间窗: 8 months

Adherence will be measured using the entire sample of program participants and will be defined by percentage of participants that maintain communication and provide required information to resolve financial issues

次要结局

  • Financial Savings(Approximately at 8 months (following resolution of financial needs))

研究者

发起方
Jean Edward
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Edward

Associate Professor

University of Kentucky

研究点 (1)

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