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Clinical Trials/NCT06246409
NCT06246409
Recruiting
Not Applicable

Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy

University of Florida2 sites in 1 country650 target enrollmentDecember 24, 2024

Overview

Phase
Not Applicable
Intervention
Existing patient instructions
Conditions
Cancer
Sponsor
University of Florida
Enrollment
650
Locations
2
Primary Endpoint
Unintentional missed treatment days
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort.

Registry
clinicaltrials.gov
Start Date
December 24, 2024
End Date
December 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients ≥ 18 years old planning their first external beam radiotherapy
  • Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion Criteria

  • Have received external beam radiotherapy in the past
  • External beam radiotherapy is initiated as inpatient.
  • External beam radiotherapy consists of less than 3 fractions.
  • Planned radiotherapy that does not employ an external beam
  • Planned participation in a clinical study that prohibits participation in a second, concurrent treatment trial
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Arms & Interventions

Arm 1: Existing patient instructions

Intervention: Existing patient instructions

Arm 2: Modernized patient instructions

Intervention: Modernized patient instructions

Outcomes

Primary Outcomes

Unintentional missed treatment days

Time Frame: 8 weeks

Determine the number of unintentional missed days of treatment during a course of radiotherapy

Secondary Outcomes

  • Unplanned clinic visits(8 weeks)
  • Emergency department visits(8 weeks)
  • Hospitalizations(8 weeks)
  • Patient-reported comfort(8 weeks)
  • Patient participation in treatment(8 weeks)
  • Rate of treatment completion(8 weeks)

Study Sites (2)

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