Connecting People With Cancer to Employment Support

NCT07027449 — Not applicable, Not yet recruiting, 70 participants, University of Kansas Medical Center

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Implementing Pathways to Identify and Address Employment Concerns Among People With Cancer Across Diverse Clinical Settings

RegistryNCT07027449
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, health services research
Enrollment70 (Estimated)
SponsorUniversity of Kansas Medical Center (Other)
ConditionsCancer
InterventionsScreening and Referral Workflow (Behavioral)
Datesstart 2028-01-01 (estimated), primary completion 2029-06-01 (estimated), completion 2029-06-01 (estimated), first posted 2025-06-18, last updated 2025-06-18

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Screening and Referral WorkflowExperimentalBehavioral: Screening and Referral Workflow
  • 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Investigators