Connecting People With Cancer to Employment Support

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT07027449
• Lead Sponsor: University of Kansas Medical Center

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).

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2028-01
• Primary Completion: 2029-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
Employment Concerns Screening	Baseline	Proportion of eligible patients screened for employment concerns

Secondary Outcome Measures

Name	Time	Method
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).