NCT07027449

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
17mo left

Started Jan 2028

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

May 27, 2025

Last Update Submit

June 16, 2025

Conditions

Keywords

employmentsocial needsscreening

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (6)

  • Employment status

    Baseline; 6 months

  • Sick leave duration

    Baseline; 6 months

  • Health-related quality of life

    Baseline; 6 months

  • Health insurance status

    Baseline; 6 months

  • Self-efficacy

    Baseline; 6 months

  • +1 more secondary outcomes

Study Arms (1)

Screening and Referral Workflow

EXPERIMENTAL
Behavioral: Screening and Referral Workflow

Interventions

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.

Screening and Referral Workflow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Rachel C. Forcino, PhD, MSc

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel C. Forcino, PhD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 18, 2025

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share