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

University of Florida650 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

650

Conditions

Cancer

Interventions

Modernized patient instructionsBEHAVIORAL

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

Existing patient instructionsBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida

Gainesville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Unintentional missed treatment days

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

Time frame: 8 weeks

Secondary Outcomes

Patient-reported comfort

Evaluate patient-reported comfort with participation in radiotherapy.

Time frame: 8 weeks

Unplanned clinic visits

Determine the average number of unplanned clinic visits during radiotherapy.

Time frame: 8 weeks

Emergency department visits

Determine the average number of emergency department visits during radiotherapy.

Time frame: 8 weeks

Hospitalizations

Determine the average number of hospitalizations during radiotherapy.

Time frame: 8 weeks

Rate of treatment completion

Determine the rate of completion of the prescribed number of radiotherapy treatments.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Central Contacts

Amy Carrao-Tackett

CONTACT

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

Data from ClinicalTrials.gov

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