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

Not Applicable

Recruiting

• Conditions: Patient Education in Radiation Oncology
• Interventions: Behavioral: Culturally Oriented Educational Brochure; Behavioral: Mayo Clinic Educational Booklet

• Registration Number: NCT04839679
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally Oriented Education	Culturally Oriented Educational Brochure	Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet
Standard of Care Mayo Clinic booklet	Mayo Clinic Educational Booklet	Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment
Culturally Oriented Education	Mayo Clinic Educational Booklet	Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet

Primary Outcome Measures

Name	Time	Method
Change in patient anxiety	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)
Radiotherapy completion rates in the AI/AN community	90 days	Number of participates to complete radiation therapy as prescribed
Change in patient perception of information received	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).

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States