Patient Education in Radiation OncologyNCT04839679
A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy
A study testing Culturally Oriented Educational Brochure and Mayo Clinic Educational Booklet in people with Patient Education in Radiation Oncology, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Education in Radiation Oncology
- What is being tested?
- Culturally Oriented Educational Brochure and Mayo Clinic Educational Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient < 18 years of age.
- Patient does not have a cancer diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Patient Education in Radiation Oncology
- Being tested
- Culturally Oriented Educational Brochure, Mayo Clinic Educational Booklet
- Keywords
- Radiation therapy, Patient education, Radiation oncology, Native Americans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Oriented Educational BrochureBehavioural
Culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner
Mayo Clinic Educational BookletBehavioural
"An Introduction to Radiation Simulation and Treatment"- Barbara Woodward Lips, Patient Education Center
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Mayo Clinic booklet | Active comparator | Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment Receives: Behavioral: Mayo Clinic Educational Booklet |
| Culturally Oriented Education | Experimental | Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet Receives: Behavioral: Culturally Oriented Educational Brochure; Behavioral: Mayo Clinic Educational Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, day 14
Radiotherapy completion rates in the AI/AN community
Number of participates to complete radiation therapy as prescribed
Measured: 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).
Measured: Baseline, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start30 Mar 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Education in Radiation OncologyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir Patel, Mayo Clinic
- Investigators
- Samir H. Patel, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839679
- Sponsor's protocol ID
- 20-005385
- Other IDs
- NCI-2021-13435
- Status last verified
- May 2025
- First submitted
- 7 Apr 2021
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04839679
- Acronym / sponsor ID
- 20-005385
- Conditions
- Patient Education in Radiation Oncology
- Keywords
- Radiation therapy, Patient education, Radiation oncology, Native Americans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Mayo Clinic booklet | Active comparator | Behavioral: Mayo Clinic Educational BookletSubjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment |
| Culturally Oriented Education | Experimental | Behavioral: Culturally Oriented Educational Brochure, Behavioral: Mayo Clinic Educational BookletSubjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient < 18 years of age.
- Patient does not have a cancer diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Oriented Educational BrochureCulturally appropriate educational brochure summarizing pertinent treatment information in a visual manner | Behavioural | Culturally Oriented Education |
| Mayo Clinic Educational Booklet"An Introduction to Radiation Simulation and Treatment"- Barbara Woodward Lips, Patient Education Center | Behavioural | Culturally Oriented Education, Standard of Care Mayo Clinic booklet |
Primary outcome
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)
Radiotherapy completion rates in the AI/AN community
Time frame: 90 days
Number of participates to complete radiation therapy as prescribed
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).
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir H. Patel, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Oriented Educational Brochure and Mayo Clinic Educational Booklet in people with Patient Education in Radiation Oncology, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient anxiety (time frame: Baseline, day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.