Longitudinal Assessment of Financial Burden in Patients With Colon or Rectal Cancer Treated With Curative Intent
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 565
- 试验地点
- 1,256
- 主要终点
- Comprehensive Score for Financial Toxicity (COST)
研究概览
简要总结
This research trial studies the financial burden in patients with stage I-III colon or rectal cancer who are undergoing treatment. Collecting data from patients about their cost and quality of life may help doctors to better understand the impact of cancer treatment on a patient?s employment and finances.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the change in level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months after diagnosis of colon or rectal cancer treated with curative-intent.
SECONDARY OBJECTVIES:
I. Evaluate reported access and utilization of financial services (i.e. financial counselor, navigator, social workers) and its association to financial burden in the first 12 months after diagnosis of colon or rectal cancer treated with curative-intent.
II. Evaluate the change in level of self-reported financial burden and employment limitations from baseline (within 60 days of diagnosis) to 3, 6, and 12 months after diagnosis of colon or rectal cancer treated with curative-intent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must have a life expectancy of >= 24 months
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- •Patients must have a newly diagnosed colon or rectal cancer (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have not yet received radiation or chemotherapy
- •Patients must have stage I, II, or III disease at the time of enrollment and will be treated with curative-intent; this can be defined either clinically or pathologically if they have already undergone surgery; for staging of both colon and rectal cancer, the definition of stage I-III is based on the seventh edition (2010) or an updated version of the tumor, node, metastasis (TNM) staging system
- •Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration; they can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period
- •Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate
- •Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible
- •Patients must be able to complete questionnaires in English
- •Patients must sign and give written informed consent in accordance with institutional and federal guidelines
排除标准
- 未提供
研究组 & 干预措施
Observational (questionnaire)
Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
干预措施: Quality-of-Life Assessment (Other)
Observational (questionnaire)
Patients complete questionnaires over 20-60 minutes at baseline and at 3, 6, 12, and 24 months after cancer diagnosis.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Comprehensive Score for Financial Toxicity (COST)
时间窗: Baseline and 12 months after cancer diagnosis
The Comprehensive Score for Financial Toxicity (COST) COST is an 11-item patient-reported outcome (PRO) of financial hardship that uses a 7-day time window and 5-point Likert response scale (ranging from 0, indicating not at all, to 4, very much). Higher COST scores (range, 0-44) represent better financial well-being. The primary objective is to evaluate the change in the level of self-reported financial burden from baseline (within 60 days of diagnosis) to 12 months from study registration. (12 mo - baseline)
次要结局
- Reported Access and Utilization of Financial Services(Up to 12 months)
- Change in Level of Self-reported Employment Limitations(Baseline, 6, 12, and 24 months after cancer diagnosis)
- Level of Self-reported Employment Limitations (Dichotomized)(Baseline, 6, 12, and 24 months after cancer diagnosis)
- Long Term Outcomes After Diagnosis for Adherence(At 24 months)
- Long Term Outcomes After Diagnosis for Financial Burden(At 24 months)
- Long Term Outcomes After Diagnosis for Employment Limitations(At 24 months)
- Change of Quality-of-life (QoL) Outcome(Baseline up to 12 months)
- Changes Self-reported Financial Burden Between Baseline and 12 Month [EORTC](Baseline and12 months)