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

March 3, 2026 updated by: University of Florida
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Alexandra De Leo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Existing patient instructions
Behavioral: Existing patient instructions
Patients will be given the patient instructions currently in use prior to radiotherapy treatment.
Experimental: Arm 2: Modernized patient instructions
Behavioral: Modernized patient instructions
Patients will be given modernized patient instructions prior to radiotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unintentional missed treatment days
Time Frame: 8 weeks
Determine the number of unintentional missed days of treatment during a course of radiotherapy
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported comfort
Time Frame: 8 weeks
Evaluate patient-reported comfort with participation in radiotherapy.
8 weeks
Unplanned clinic visits
Time Frame: 8 weeks
Determine the average number of unplanned clinic visits during radiotherapy.
8 weeks
Emergency department visits
Time Frame: 8 weeks
Determine the average number of emergency department visits during radiotherapy.
8 weeks
Hospitalizations
Time Frame: 8 weeks
Determine the average number of hospitalizations during radiotherapy.
8 weeks
Rate of treatment completion
Time Frame: 8 weeks
Determine the rate of completion of the prescribed number of radiotherapy treatments.
8 weeks
Patient participation in treatment
Time Frame: 8 weeks
Determine the percentage of patients fully participating in their radiotherapy treatment, as assessed by Likert scale ratings given by the therapist. Patients will be rated by the therapist on factors such as correct patient-initiated alignment of body, holding still, and following breath-hold directions.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Alexandra De Leo, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF-CCPS-038
  • IRB202401379 (Other Identifier: University of Florida)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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