Patient Education in Radiation Oncology Clinical Trial
Official title:
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)
| Verified date | April 2024 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | April 1, 2025 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic in Arizona | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Radiotherapy completion rates in the AI/AN community | Number of participates to complete radiation therapy as prescribed | 90 days | |
| Primary | 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 |