The Intersection of Oncology Care and Worker Well-Being

NCT05250284 | Recruiting DMC

• 2 other identifiers: 21-4139.ccU19OH011227
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Employment Hours Worked

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

  2 years

• Worker Well-being

  Worker well-being will be measured by the NIOSH WellBQ

  2 years

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

  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.

  2 years

• Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains

  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.

  2 years

• Financial Burden of Employed Males with Cancer

  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.

  2 yearas

Interventions

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.

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

sample consists of employed men newly diagnosed with a first primary solid tumor. define employed as working 10+ hours per week at diagnosis with the intention to continue working or return to work. Patients must be aged 21 to 70 years and within 2 months of initiating infusion chemotherapy, oral agent, or radiation therapy.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Cathy Bradley

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Brown, PhD

CONTACT

562.587.9123; carol.brown@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 22, 2022
• Study Start: April 4, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (1)