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

May 5, 2025 updated by: Samir Patel, Mayo Clinic

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient anxiety
Time Frame: Baseline, day 14
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
Time Frame: 90 days
Number of participates to complete radiation therapy as prescribed
90 days
Change in patient perception of information received
Time Frame: Baseline, day 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Samir H. Patel, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-005385
  • NCI-2021-13435 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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