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

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Behavioral: Existing patient instructions; Behavioral: Modernized patient instructions

• Registration Number: NCT06246409
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-12-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1: Existing patient instructions	Existing patient instructions	-
Arm 2: Modernized patient instructions	Modernized patient instructions	-

Primary Outcome Measures

Name	Time	Method
Unintentional missed treatment days	8 weeks	Determine the number of unintentional missed days of treatment during a course of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Unplanned clinic visits	8 weeks	Determine the average number of unplanned clinic visits during radiotherapy.
Emergency department visits	8 weeks	Determine the average number of emergency department visits during radiotherapy.
Hospitalizations	8 weeks	Determine the average number of hospitalizations during radiotherapy.
Patient-reported comfort	8 weeks	Evaluate patient-reported comfort with participation in radiotherapy.
Patient participation in treatment	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.
Rate of treatment completion	8 weeks	Determine the rate of completion of the prescribed number of radiotherapy treatments.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States