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

NCT ID: NCT06246409

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1: Existing patient instructions

Group Type ACTIVE_COMPARATOR

Existing patient instructions

Intervention Type BEHAVIORAL

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

Arm 2: Modernized patient instructions

Group Type EXPERIMENTAL

Modernized patient instructions

Intervention Type BEHAVIORAL

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

Interventions

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Modernized patient instructions

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

Intervention Type BEHAVIORAL

Existing patient instructions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Hitchcock, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Carrao-Tackett

Role: CONTACT

352-265-8826

Facility Contacts

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Amy Carrao-Tackett

Role: primary

352-265-8826

Other Identifiers

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IRB202401379

Identifier Type: OTHER

Identifier Source: secondary_id

UF-CCPS-038

Identifier Type: -

Identifier Source: org_study_id

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