About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males
Ages 21 to 70
Newly diagnosed with a first primary solid tumor
colorectal, lung, and head and neck
Disqualifiers
None
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
WellBQ
BehavioralNational 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
BehavioralPatient-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.
Treatment groups
Trial outcomes
Primary outcomes
Employment Hours Worked
Employment and weekly hours worked will be assessed using questions from the Current Population Survey (CPS)
Worker Well-being
Worker well-being will be measured by the NIOSH WellBQ
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.
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.
Sponsors and contacts
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University of Colorado, Denver
Lead sponsor
National Institute for Occupational Safety and Health (NIOSH/CDC)
Collaborator