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Recruiting NCT05250284

The Intersection of Oncology Care and Worker Well-Being

Observational Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WellBQ, PROMIS.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 21 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral WellBQ
    National Institue for Occupational Safety and Health Worker Well-Being Questionnaire is comprised of 21 scales (multiple items assessing a single construct) and 31 single items that cover worker well-being. Domains include (i) work evaluation and experience, (ii) workplace policies and culture, (iii) workplace physical environment and safety climate, (iv) health status, and (v) home, community, and society.
  • Behavioral PROMIS
    Patient-Reported Outcomes Measurement Information System is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.

Primary outcome measures

  • Employment Hours Worked [Time frame: 2 years]
  • Worker Well-being [Time frame: 2 years]
  • Psychosocial Outcomes of Employed Males with Cancer using the validated Stress Thermometer. [Time frame: 2 years]
  • Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains [Time frame: 2 years]
  • Financial Burden of Employed Males with Cancer [Time frame: 2 yearas]

Eligibility criteria

Inclusion criteria

  • Males
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT05250284 · 21-4139.cc · U19OH011227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗