Recruiting

Radiotherapy

Sponsor:

University of Florida

Code:

NCT06246409

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Modernized patient instructions

Existing patient instructions

Study Details

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.

Conditions

Cancer

Study ID

NCT06246409

Start date

Dec 24, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

650 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Existing patient instructions

experimental: Arm 2: Modernized patient instructions

Interventions

Modernized patient instructions

Patients will be given modernized patient instructions prior to radiotherapy treatment.

Existing patient instructions

Patients will be given the patient instructions currently in use prior to radiotherapy treatment.

Primary outcome measure

  • Unintentional missed treatment days [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Amy Carrao-Tackett

352-265-8826amy.carrao-tackett@ufhealth.org

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Amy Carrao-Tackett

352-265-8826amy.carrao-tackett@ufhealth.org

Principal Investigator:

Alexandra De Leo, MD

More Information

Sponsor

University of Florida

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • patient comfort
  • patient participation
  • external beam radiotherapy
  • radiation oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-04.