CClinicalTrials.gg
TerminatedNCT04839679Updated May 8, 2025

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

An interventional study of Culturally Oriented Educational Brochure and Mayo Clinic Educational Booklet in Patient Education in Radiation Oncology, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Why this study was terminated
Slow accrual
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Patient Education in Radiation Oncology

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Keywords

  • Radiation therapy
  • Patient education
  • Radiation oncology
  • Native Americans
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 51 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient \< 18 years of age.
  • Patient does not have a cancer diagnosis.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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

  • 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: Culturally Oriented Educational Brochure · Behavioral: Mayo Clinic Educational Booklet

Interventions

  • BehavioralCulturally Oriented Educational Brochure

    Culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner

  • BehavioralMayo Clinic Educational Booklet

    "An Introduction to Radiation Simulation and Treatment"- Barbara Woodward Lips, Patient Education Center

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline, day 14

  2. Radiotherapy completion rates in the AI/AN community

    Number of participates to complete radiation therapy as prescribed

    Time frame: 90 days

  3. 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).

    Time frame: Baseline, day 14

07

Study locations

1 site
  • Mayo Clinic in Arizona
    Phoenix, Arizona 85054, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04839679
Lead sponsor
Mayo Clinic
Responsible party
Samir Patel (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 9, 2021
Start date
Mar 30, 2021
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025
Last update
May 8, 2025

Study contacts

Samir H. Patel, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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