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

NCT06246409 | Recruiting

• 2 other identifiers: UF-CCPS-038IRB202401379
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Unintentional missed treatment days

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

  8 weeks

Secondary Outcomes (6)

• Patient-reported comfort

  8 weeks

• Unplanned clinic visits

  8 weeks

• Emergency department visits

  8 weeks

• Hospitalizations

  8 weeks

• Rate of treatment completion

  8 weeks

Study Arms (2)

Arm 1: Existing patient instructions

ACTIVE COMPARATOR

Behavioral: Existing patient instructions

Arm 2: Modernized patient instructions

EXPERIMENTAL

Behavioral: Modernized patient instructions

Interventions

Modernized patient instructions BEHAVIORAL

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

Arm 2: Modernized patient instructions

Existing patient instructions BEHAVIORAL

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

Arm 1: Existing patient instructions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Alexandra De Leo, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Carrao-Tackett

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)