Clinical trial NCT05250284: The Intersection of Oncology Care and Worker Well-Being
Official title: The Intersection of Oncology Care and Worker Well-Being
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Keywords: Newly Diagnosed Primary Solid Tumor
Men
Employed
Chemotherapy
Oral Agent
Radiation Therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2022-02-22
Enrollment: 400
Sex: MALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Employment Hours Worked
timeFrame: 2 years
measure: Worker Well-being
timeFrame: 2 years
measure: Psychosocial Outcomes of Employed Males with Cancer using the validated Stress Thermometer.
timeFrame: 2 years
measure: Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains
timeFrame: 2 years
measure: Financial Burden of Employed Males with Cancer
timeFrame: 2 yearas
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cathy Bradley
role: PRINCIPAL_INVESTIGATOR
References: