Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modernized patient instructions, Existing patient instructions.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Behavioral Modernized patient instructions
Patients will be given modernized patient instructions prior to radiotherapy treatment. - Behavioral Existing patient instructions
Patients will be given the patient instructions currently in use prior to radiotherapy treatment.
Primary outcome measures
- Unintentional missed treatment days [Time frame: 8 weeks]
Secondary outcome measures (6)
- Patient-reported comfort [Time frame: 8 weeks]
- Unplanned clinic visits [Time frame: 8 weeks]
- Emergency department visits [Time frame: 8 weeks]
- Hospitalizations [Time frame: 8 weeks]
- Rate of treatment completion [Time frame: 8 weeks]
- Patient participation in treatment [Time frame: 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT06246409 · UF-CCPS-038 · IRB202401379