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NCT Number: NCT06246409

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

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.

Recruiting

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Alexandra De Leo, MD

PRINCIPAL_INVESTIGATOR

Amy Carrao-Tackett

CONTACT

[email protected]

352-265-8826

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modernized patient instructions

Behavioral

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

Existing patient instructions

Behavioral

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

Primary outcomes

  1. Unintentional missed treatment days

    Time frame: 8 weeks

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

Secondary outcomes

  1. Patient-reported comfort

    Time frame: 8 weeks

    Evaluate patient-reported comfort with participation in radiotherapy.

  2. Unplanned clinic visits

    Time frame: 8 weeks

    Determine the average number of unplanned clinic visits during radiotherapy.

  3. Emergency department visits

    Time frame: 8 weeks

    Determine the average number of emergency department visits during radiotherapy.

  4. Hospitalizations

    Time frame: 8 weeks

    Determine the average number of hospitalizations during radiotherapy.

  5. Rate of treatment completion

    Time frame: 8 weeks

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

  6. Patient participation in treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Carrao-Tackett

CONTACT

[email protected]

352-265-8826

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: PEERs

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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