Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05250284

Conditions

Solid Tumor

Eligibility Criteria

Sex: Male

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

WellBQ

PROMIS

Study Details

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

Study ID

NCT05250284

Start date

Apr 4, 2022

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Carol Brown, PhD

562.587.9123carol.brown@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Carol Brown

carol.brown@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-13.