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

Cancer Clinical Trial

— PEERs  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06246409
• Other study ID #: UF-HN-005
• Status: Withdrawn
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unintentional missed treatment days	Determine the number of unintentional missed days of treatment during a course of radiotherapy	8 weeks
Secondary	Patient-reported comfort	Evaluate patient-reported comfort with participation in radiotherapy.	8 weeks
Secondary	Unplanned clinic visits	Determine the average number of unplanned clinic visits during radiotherapy.	8 weeks
Secondary	Emergency department visits	Determine the average number of emergency department visits during radiotherapy.	8 weeks
Secondary	Hospitalizations	Determine the average number of hospitalizations during radiotherapy.	8 weeks
Secondary	Rate of treatment completion	Determine the rate of completion of the prescribed number of radiotherapy treatments.	8 weeks
Secondary	Patient participation in treatment	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