The Intersection of Oncology Care and Worker Well-Being

• ClinicalTrials.gov Identifier: NCT05250284
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2022
• Last Update Posted: May 8, 2024
• Sponsor: University of Colorado, Denver
• Collaborator: National Institute for Occupational Safety and Health (NIOSH/CDC)
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment
Solid Tumor	Behavioral: WellBQ; Behavioral: PROMIS

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 134 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Intersection of Oncology Care and Worker Well-Being
• Actual Study Start Date: April 4, 2022
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: August 2025

Groups and Cohorts

Intervention Details:

• Behavioral: 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.
• 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.

Outcome Measures

Primary Outcome Measures :

1. Employment Hours Worked [ Time Frame: 2 years ]
   Employment and weekly hours worked will be assessed using questions from the Current Population Survey (CPS)
2. Worker Well-being [ Time Frame: 2 years ]
   Worker well-being will be measured by the NIOSH WellBQ
3. Psychosocial Outcomes of Employed Males with Cancer using the validated Stress Thermometer. [ Time Frame: 2 years ]
   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.
4. Psychosocial Outcomes of Employed Males with Cancer using PROMIS domains [ Time Frame: 2 years ]
   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.
5. Financial Burden of Employed Males with Cancer [ Time Frame: 2 yearas ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

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

Investigators

• Principal Investigator: Cathy Bradley; University of Colorado - Anschutz Medical Campus

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT05250284
• Other Study ID Numbers: 21-4139.cc; U19OH011227 ( U.S. NIH Grant/Contract )
• First Posted: February 22, 2022
• Last Update Posted: May 8, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:

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