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NCT Number: NCT05250284

The Intersection of Oncology Care and Worker Well-Being

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.

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Key information

Conditions

Solid Tumor Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

21 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WellBQ

Behavioral

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.

PROMIS

Behavioral

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 outcomes

  1. Employment Hours Worked

    Time frame: 2 years

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

  2. Worker Well-being

    Time frame: 2 years

    Worker well-being will be measured by the NIOSH WellBQ

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

    Time frame: 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.

  4. Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains

    Time frame: 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.

  5. Financial Burden of Employed Males with Cancer

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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