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

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University of Florida

Status

Not yet enrolling

Conditions

Cancer

Treatments

Behavioral: Existing patient instructions
Behavioral: Modernized patient instructions

Study type

Interventional

Funder types

Other

Identifiers

NCT06246409
IRB202401379 (Other Identifier)
UF-HN-005

Details and patient eligibility

About

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.

Enrollment

650 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

650 participants in 2 patient groups

Arm 1: Existing patient instructions
Active Comparator group
Treatment:
Behavioral: Existing patient instructions
Arm 2: Modernized patient instructions
Experimental group
Treatment:
Behavioral: Modernized patient instructions

Trial contacts and locations

1

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Central trial contact

Priya Gurjar

Data sourced from clinicaltrials.gov

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