Colorectal Cancer Legal and Administrative Burden Support: A Pilot Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cancer Related Behavior Questionnaire
研究概览
简要总结
This is a single center single-arm, pilot study of proactive and early connection with free legal care services for persons with advanced colorectal cancer to assess the feasibility, acceptability, and preliminary efficacy of this intervention in improving financial and psychosocial outcomes. Participants will receive free, personalized legal care services from Cancer Legal Care (CLC), a nonprofit organization located in the Twin Cities of Minnesota. The duration of study participation is 6 months, however, participants may continue to access free personalized legal care services beyond this period. All participants continue to receive standard of care as prescribed by their treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Diagnosis of advanced stage colorectal cancer.
- •Estimated life expectancy of over 6 months in the opinion of the treating oncologist.
- •18 years of age or older at the time of consent.
- •Able to understand, speak, read, and write in English.
- •Able to provide voluntary written consent prior to the performance of any research related activity.
排除标准
- •Lacks capacity to consent/has diminished capacity to consent.
研究组 & 干预措施
Experimental group
adult patients with advanced colorectal cancel
干预措施: Personalized legal care services (Other)
结局指标
主要结局
Cancer Related Behavior Questionnaire
时间窗: baseline, 3 months, 6 months
A 31-item measure of comfort facing cancer related issues.
The Perceived Stress Scale 4 (PSS-4)
时间窗: baseline, 3 months, 6 months
A 4-item measure of perceived stress.
The Cancer Behavior Inventory-Brief Version (CBI-B)
时间窗: baseline, 3 months, 6 months
A 12-item measure of self-efficacy coping with cancer.
The Spitzer Uniscale (UNISCALE)
时间窗: baseline, 3 months, 6 months
A single-item measure of overall quality of life.
Rosenberg Self-Esteem (RSE) Scale
时间窗: baseline, 3 months, 6 months
A 10-item measure of self-esteem.
Cancer Legal Care Services Questionnaire
时间窗: baseline, 3 months, 6 months
A 13-item measure of CLC
The COmprehensive Score for financial Toxicity (COST)
时间窗: baseline, 3 months, 6 months
A 12-item measure of financial toxicity.
The National Comprehensive Cancer Network's (NCCN) Distress Thermometer
时间窗: baseline, 3 months, 6 months
A single-item measure of psychological distress.
Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)
时间窗: baseline, 3 months, 6 months
A 9-item measure of perceptions of interpersonal relationships with a patient navigator (i.e. CLC).
The Life Engagement Test (LET)
时间窗: baseline, 3 months, 6 months
A 6-item measure of purpose in life, defined as the extent to which a person engages in activities that are personally meaningful.
Pearlin Mastery Scale
时间窗: baseline, 3 months, 6 months
A 7-item measure of psychological coping (mastery).
次要结局
未报告次要终点