Cancer
Conditions
Keywords
employment, social needs, screening
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALScreening and Referral Workflow
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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible Patients: * visiting a participating medical or radiation oncology clinic for new diagnosis, treatment, or follow-up of any type of cancer; * employed at the time of cancer diagnosis; * age 18 or older; * able to give full informed consent; * able to communicate in English or Spanish. Eligible Staff: * age 18 or older; * employed at one of the participating clinical sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Employment Concerns Screening | Baseline | Proportion of eligible patients screened for employment concerns |
| Enrollment Rate | Baseline | T1 survey enrollment rate among eligible patients and staff |
| Follow-up Survey Completion Rate | 6 months | Rate of study survey completion within 18 days of the 6-month follow-up timepoint |
| Staff-reported Feasibility of Intervention | Approximately 9 months | Proportion of staff disagreeing with one or more Feasibility of Intervention Measure items |
| Acceptability of Intervention: Staff | Approximately 9 months | Proportion of staff disagreeing with one or more Acceptability of Intervention Measure items |
| Acceptability of Intervention: Patients | Baseline; 6 months | Proportion of patients providing negative ratings for one or more Theoretical Framework of Acceptability questionnaire items |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Employment status | Baseline; 6 months | Patient-reported employment status using the US Census Bureau's American Community Survey employment status items |
| Sick leave duration | Baseline; 6 months | Patient-reported sick leave duration reported in days |
| Health-related quality of life | Baseline; 6 months | 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). |
| Health insurance status | Baseline; 6 months | Patient-reported health insurance status using the US Census Bureau's American Community Survey health insurance status items |
| Self-efficacy | Baseline; 6 months | Patient-reported self-efficacy using the General Self-Efficacy Scale. Scores range 10-40, with higher scores indicating more self-efficacy (better outcome). |
| Financial toxicity | Baseline; 6 months | Patient-reported financial toxicity using the COST measure. Scores range 0-48, with higher scores indicating more financial toxicity (worse outcome). |
Contacts
Primary ContactRachel C. Forcino, PhD, MSc
Outcome results
None listed