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The goal of this clinical trial is to learn if a clinical workflow that screens adult patients with cancer for challenges at work and refers them to supportive resources is feasible, appropriate, and acceptable to patients and staff members in 2 cancer care settings. The main questions it aims to answer are:
Is the clinical workflow feasible and acceptable to participants? Are study procedures feasible and acceptable to participants?
Patient participants will complete 2 surveys: 1 at the time of enrollment and 1 six months later.
Investigators will conduct a prospective single-arm study at 2 sites to pilot and iteratively adapt a clinical workflow intervention, implementation strategies, and associated study procedures. Investigators will implement the clinical workflow intervention across each study site, then recruit consecutive patients (n=50) to complete patient-reported measures at 2 time points (T1: enrollment; T2: 6-month follow-up. Investigators will recruit staff members (n=20) to complete survey measures at 2 time points (T1: beginning of pilot study period; T2: end of pilot study period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening and Referral Workflow | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening and Referral Workflow | Behavioral | The Screening and Referral Workflow intervention will include screening eligible patients for employment-related needs and referring those who require support to community-based employment resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | T1 survey enrollment rate among eligible patients and staff | Baseline |
| Follow-up Survey Completion Rate | Rate of study survey completion within 18 days of the 6-month follow-up timepoint | 6 months |
| Staff-reported Feasibility of Intervention | Proportion of staff disagreeing with one or more Feasibility of Intervention Measure items | Approximately 9 months |
| Acceptability of Intervention: Staff | Proportion of staff disagreeing with one or more Acceptability of Intervention Measure items | Approximately 9 months |
| Acceptability of Intervention: Patients | Proportion of patients providing negative ratings for one or more Theoretical Framework of Acceptability questionnaire items | Baseline; 6 months |
| Employment Concerns Screening | Proportion of eligible patients screened for employment concerns | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Employment status | Patient-reported employment status using the US Census Bureau's American Community Survey employment status items | Baseline; 6 months |
| Sick leave duration | Patient-reported sick leave duration reported in days |
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Eligible Patients:
Eligible Staff:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel C. Forcino, PhD, MSc | Contact | 913-588-4742 | rforcino@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel C. Forcino, PhD, MSc | University of Kansas Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| Baseline; 6 months |
| Health-related quality of life | Patient-reported quality of life using the EQ-5D-5L scale. Scores range 1-5, with higher scores indicating poorer quality of life (worse outcome). | Baseline; 6 months |
| Health insurance status | Patient-reported health insurance status using the US Census Bureau's American Community Survey health insurance status items | Baseline; 6 months |
| Self-efficacy | Patient-reported self-efficacy using the General Self-Efficacy Scale. Scores range 10-40, with higher scores indicating more self-efficacy (better outcome). | Baseline; 6 months |
| Financial toxicity | Patient-reported financial toxicity using the COST measure. Scores range 0-48, with higher scores indicating more financial toxicity (worse outcome). | Baseline; 6 months |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |