Cancer
Conditions
Keywords
patient comfort, patient participation, external beam radiotherapy, radiation oncology
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.
Interventions
BEHAVIORALModernized patient instructions
Patients will be given modernized patient instructions prior to radiotherapy treatment.
BEHAVIORALExisting patient instructions
Patients will be given the patient instructions currently in use prior to radiotherapy treatment.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unintentional missed treatment days | 8 weeks | Determine the number of unintentional missed days of treatment during a course of radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported comfort | 8 weeks | Evaluate patient-reported comfort with participation in radiotherapy. |
| 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. |
| Rate of treatment completion | 8 weeks | Determine the rate of completion of the prescribed number of radiotherapy treatments. |
| 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. |
Countries
United States
Contacts
CONTACTAmy Carrao-Tackett
PRINCIPAL_INVESTIGATORAlexandra De Leo, MD
University of Florida
Outcome results
None listed