CancerPEERsNCT06246409
Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy
A study testing Modernized patient instructions and Existing patient instructions in people with Cancer, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer
- What is being tested?
- Modernized patient instructions and Existing patient instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Amy Carrao-Tackett, 352-265-8826, amy.carrao-tackett@ufhealth.org
Alexandra De Leo, MD
About this study
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.
- Conditions
- Cancer
- Being tested
- Modernized patient instructions, Existing patient instructions
- Keywords
- patient comfort, patient participation, external beam radiotherapy, radiation oncology
- Medical subject headings
- Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modernized patient instructionsBehavioural
Patients will be given modernized patient instructions prior to radiotherapy treatment.
Existing patient instructionsBehavioural
Patients will be given the patient instructions currently in use prior to radiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Existing patient instructions | Active comparator | Not described Receives: Behavioral: Existing patient instructions |
| Arm 2: Modernized patient instructions | Experimental | Not described Receives: Behavioral: Modernized patient instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintentional missed treatment days
Determine the number of unintentional missed days of treatment during a course of radiotherapy
Measured: 8 weeks
Secondary outcomes (6)
Patient-reported comfort
Evaluate patient-reported comfort with participation in radiotherapy.
Measured: 8 weeks
Unplanned clinic visits
Determine the average number of unplanned clinic visits during radiotherapy.
Measured: 8 weeks
Emergency department visits
Determine the average number of emergency department visits during radiotherapy.
Measured: 8 weeks
Hospitalizations
Determine the average number of hospitalizations during radiotherapy.
Measured: 8 weeks
Rate of treatment completion
Determine the rate of completion of the prescribed number of radiotherapy treatments.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start24 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra De Leo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246409
- Sponsor's protocol ID
- UF-CCPS-038
- Other IDs
- IRB202401379
- Acronym
- PEERs
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy
- ClinicalTrials.gov ID
- NCT06246409
- Acronym / sponsor ID
- PEERs / UF-CCPS-038
- Conditions
- Cancer
- Keywords
- patient comfort, patient participation, external beam radiotherapy, radiation oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Existing patient instructions | Active comparator | Behavioral: Existing patient instructions |
| Arm 2: Modernized patient instructions | Experimental | Behavioral: Modernized patient instructions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modernized patient instructionsPatients will be given modernized patient instructions prior to radiotherapy treatment. | Behavioural | Arm 2: Modernized patient instructions |
| Existing patient instructionsPatients will be given the patient instructions currently in use prior to radiotherapy treatment. | Behavioural | Arm 1: Existing patient instructions |
Primary outcome
Unintentional missed treatment days
Time frame: 8 weeks
Determine the number of unintentional missed days of treatment during a course of radiotherapy
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra De Leo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modernized patient instructions and Existing patient instructions in people with Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Carrao-Tackett (352-265-8826, amy.carrao-tackett@ufhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unintentional missed treatment days (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.