The Intersection of Oncology Care and Worker Well-Being

NCT ID: NCT05250284

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2027-08-31

Brief Summary

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.

Conditions

Solid Tumor

Keywords

Newly Diagnosed Primary Solid Tumor; Men; Employed; Chemotherapy; Oral Agent; Radiation Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

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

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathy Bradley

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carol Brown, PhD

Role: CONTACT

Phone: 562.587.9123

Email: carol.brown@cuanschutz.edu

Facility Contacts

Carol Brown

Role: primary

Other Identifiers

U19OH011227

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-4139.cc

Identifier Type: -

Identifier Source: org_study_id