跳至主要内容
临床试验/NCT05250284
NCT05250284招募中不适用

The Intersection of Oncology Care and Worker Well-Being

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
2
主要终点
Worker Well-being

研究概览

简要总结

The goals of this study will be a greater understanding of cancer patients' well-being experience through the care/treatment continuum. An important aspect of the study is an understanding of work- and treatment-related challenges experienced by low-income men, many of whom will be Latino. At the 12-month observation period, the investigators will learn whether these men work long-term and how work status relates to well-being.

详细描述

Labor supply and well-being outcomes will be evaluated at 3 timepoints (baseline, start of treatment, 12 months). The likelihood of remaining employed will be estimated with linear probability models as is the convention in labor economics. The study team also estimate employment using analogous logistic models, reporting marginal effects. Weekly hours worked will be estimated using ordinary least squares regression. In addition to measuring raw hours, the team estimate change and percent change in hours worked from baseline. These models can be expanded to accommodate control variables for worksite and job characteristics as well as accommodations, satisfaction, and other covariates predictive employment and hours worked.

Well-being will be assessed as specified by the Worker Well-Being Questionnaire (WellBQ) Manual23 and Patient Reported Outcomes Measurement Information Systems (PROMIS) domains. For PROMIS, subjects respond to a 4-item questionnaire for each domain. Responses are summed and standardized to t-scores, with higher t-scores representing higher levels of the domain measured. For example, an individual with a PROMIS depression t-score of 50 is the average observed in the general U.S. population, while a t-score of 60 indicates one standard deviation above the average score in the general population and represents moderate depressive symptoms. Guided by previous health literature, the team consider a half standard deviation (5-point) increase from initial scores a meaningful improvement for all PROMIS domains. The literature also suggests that meaningful change ranges from 2 to 6 points. Secondary to Aim 1, the team will assess the correlation between PROMIS measures and WellBQ. The WellBQ is at an earlier stage of adoption, warranting side-by-side comparison with established instruments like PROMIS. The InCharge instrument will be evaluated as suggested by the developers.

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
21 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Ages 21 to 70
  • •Newly diagnosed with a first primary solid tumor
  • •colorectal, lung, and head and neck
  • •Currently employed (defined as working 10+ hours per week) with the intention to continue working or return to work
  • •Within 2 months of initiating infusion chemotherapy, oral agent, or radiation therapy

排除标准

  • 未提供

结局指标

主要结局

Worker Well-being

时间窗: 2 years

Worker well-being will be measured by the NIOSH WellBQ

Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains

时间窗: 2 years

Psychosocial outcomes will be measured using the validated PROMIS domains. Subjects respond to a 4-item questionnaire for each domain. Responses are summed and standardized to t-scores, with higher t-scores representing higher levels of the domain measured. For example, an individual with a PROMIS depression t-score of 50 is the average observed in the general U.S. population, while a t-score of 60 indicates one standard deviation above the average score in the general population and represents moderate depressive symptoms.

Financial Burden of Employed Males with Cancer

时间窗: 2 yearas

A systematic review of methods for measuring financial burden following cancer treatment identified 6 subdomains that represent perceptions of and reactions to financial distress: (i) financial spending, (ii) use of passive financial resources, (iii) psychosocial responses, (iv) support seeking, (v) coping with care or (vi) coping with ones' lifestyle.64 We chose the InCharge Financial Well-being/Financial Distress Scale (8 items) that covers most domains and is widely used in cancer patients.

Employment Hours Worked

时间窗: 2 years

Employment and weekly hours worked will be assessed using questions from the Current Population Survey (CPS)

Psychosocial Outcomes of Employed Males with Cancer using the validated Stress Thermometer.

时间窗: 2 years

Depression and anxiety will be measured using the well-validated Stress Thermometer, a single item tool using a 0 (no distress) to 10 (extreme distress) - point Likert scale resembling a thermometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验