A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy

Study Overview
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Brief Summary
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This research study is being done in order to better understand and identify American Indian/Alaskan Native (AI/AN) cancer patients' attitudes and beliefs towards radiation therapy treatment plans and their willingness to pursue them.

Official Title
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A Randomized Clinical Trial to Study the Utility of Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy in American Indian and Alaska Native Individuals (VIEW Study)

Conditions
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Patient Education in Radiation Oncology

Intervention / Treatment
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* Behavioral: Culturally Oriented Educational Brochure
* Behavioral: Mayo Clinic Educational Booklet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at least 18 years of age with cancer diagnosis. Radiation therapy is recommended for their cancer treatment as a next step in their cancer care. Cognitive capacity to complete a paper-and-pencil survey. Ability to communicate and understand English with proficiency to provide informed consent and complete a paper-and-pencil survey. Exclusion Criteria: Patient < 18 years of age. Patient does not have a cancer diagnosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Mayo Clinic booklet<br>Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment | Behavioral: Mayo Clinic Educational Booklet<br>* An Introduction to Radiation Simulation and Treatment- Barbara Woodward Lips, Patient Education Center<br>|
| Experimental: Culturally Oriented Education<br>Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet | Behavioral: Culturally Oriented Educational Brochure<br>* Culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner<br>Behavioral: Mayo Clinic Educational Booklet<br>* An Introduction to Radiation Simulation and Treatment- Barbara Woodward Lips, Patient Education Center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient anxiety | Measured using self-reported Hospital Anxiety and Depression Scale (HADS) Survey to ascertain any anxiety and/or depression that they may be experiencing with respect to their diagnosis and treatment. Questionnaire total score reported on a scale of 0-7 = normal, 8-10 borderline abnormal (borderline case), 11-21 abnormal (case) | Baseline, day 14 | 
| Radiotherapy completion rates in the AI/AN community | Number of participates to complete radiation therapy as prescribed | 90 days | 
| Change in patient perception of information received | Measured by the EORTC QLQ - INFO25 survey, which is a validated instrument that will gauge their satisfaction with the information they received regarding their diagnosis and treatment plan. Questionnaire of 24 questions regarding information received during treatment using a scale of 1 (not at all) to 4 (very much). | Baseline, day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation therapy, Patient education, Radiation oncology, Native Americans