Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Existing patient instructions
- Conditions
- Cancer
- Sponsor
- University of Florida
- Enrollment
- 650
- Locations
- 2
- Primary Endpoint
- Unintentional missed treatment days
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Arm 1: Existing patient instructions
Intervention: Existing patient instructions
Arm 2: Modernized patient instructions
Intervention: Modernized patient instructions
Outcomes
Primary Outcomes
Unintentional missed treatment days
Time Frame: 8 weeks
Determine the number of unintentional missed days of treatment during a course of radiotherapy
Secondary Outcomes
- Unplanned clinic visits(8 weeks)
- Emergency department visits(8 weeks)
- Hospitalizations(8 weeks)
- Patient-reported comfort(8 weeks)
- Patient participation in treatment(8 weeks)
- Rate of treatment completion(8 weeks)