MelanomaPhase 2NCT05388851
Education for Prevention of Melanoma in Hispanic Populations
A Phase 2 study testing Educational Intervention and Questionnaire Administration in people with Melanoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial is to develop an educational platform to educate and prevent melanoma in Hispanic populations. Melanoma is cancer arising in the skin. Educational platforms to increase the knowledge and practice of sun smart behaviors (sunscreen use, sun protective clothing use, self-skin examination) may help… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- Educational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2022to 13 Sep 2022
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mayo Clinic patients who self-identify as Hispanic or Latino
- Age 18 and older
- Have an email on file with Mayo Clinic
Who cannot join
- All patients who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial is to develop an educational platform to educate and prevent melanoma in Hispanic populations. Melanoma is cancer arising in the skin. Educational platforms to increase the knowledge and practice of sun smart behaviors (sunscreen use, sun protective clothing use, self-skin examination) may help reduce risk of and incidence of melanoma and improve cancer survival.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop online education platform to educate the Hispanic community. II. Demonstrate improvement in knowledge and practice of sun smart behaviors. III. Determine if the education platform leads to increase visits to their medical provider and increase diagnosis of skin cancers, particularly melanoma, in our population.
OUTLINE:
Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.
- Conditions
- Melanoma
- Being tested
- Educational Intervention, Questionnaire Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete educational training module
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Prevention (Educational training) | Experimental | Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge score after completing the educational module
For quantitative variables, descriptive statistics including number of observations, mean, median, standard deviation, and range will be given for the values. Qualitative variables will be summarized using counts and percentages. Associations between quantitative variables will be conducted using the Pearson linear correlation coefficient, and the Chi-squared or Fisher's exact test for categorical variables.The melanoma knowledge score will be a percent correct, between 0% and 100% (100% is the best score), on a participant questionnaire. The primary outcome is the change in participant melanoma knowledge score before and immediately after completing the melanoma education (the intervention in this study).
Measured: Up to 3 months
Secondary outcomes (1)
Knowledge score three months after completing the educational module
For quantitative variables, descriptive statistics including number of observations, mean, median, standard deviation, and range will be given for the values. Qualitative variables will be summarized using counts and percentages. Associations between quantitative variables will be conducted using the Pearson linear correlation coefficient, and the Chi-squared or Fisher's exact test for categorical variables.The secondary outcome is their melanoma knowledge score at the three-month follow-up.
Measured: 3 months after completing education module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start12 Jan 2022
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Why it stopped: Low/slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron R Mangold, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388851
- Sponsor's protocol ID
- 21-010065
- Other IDs
- NCI-2022-03769
- Status last verified
- Jun 2025
- First submitted
- 19 May 2022
- Last updated
- 22 Jun 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education for Prevention of Melanoma in Hispanic Populations
- ClinicalTrials.gov ID
- NCT05388851
- Acronym / sponsor ID
- 21-010065
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low/slow accrual
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 24 May 2022 (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 clinical trial is to develop an educational platform to educate and prevent melanoma in Hispanic populations. Melanoma is cancer arising in the skin. Educational platforms to increase the knowledge and practice of sun smart behaviors (sunscreen use, sun protective clothing use, self-skin examination) may help reduce risk of and incidence of melanoma and improve cancer survival.
Detailed description
PRIMARY OBJECTIVES:
- Develop online education platform to educate the Hispanic community. II. Demonstrate improvement in knowledge and practice of sun smart behaviors. III. Determine if the education platform leads to increase visits to their medical provider and increase diagnosis of skin cancers, particularly melanoma, in our population.
OUTLINE:
Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Educational training) | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationParticipants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mayo Clinic patients who self-identify as Hispanic or Latino
- Age 18 and older
- Have an email on file with Mayo Clinic
Key exclusion criteria (1 listed)
- All patients who do not meet inclusion criteria
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete educational training module | Other | Prevention (Educational training) |
| Questionnaire AdministrationComplete questionnaire | Other | Prevention (Educational training) |
Primary outcome
Knowledge score after completing the educational module
Time frame: Up to 3 months
For quantitative variables, descriptive statistics including number of observations, mean, median, standard deviation, and range will be given for the values. Qualitative variables will be summarized using counts and percentages. Associations between quantitative variables will be conducted using the Pearson linear correlation coefficient, and the Chi-squared or Fisher's exact test for categorical variables.The melanoma knowledge score will be a percent correct, between 0% and 100% (100% is the best score), on a participant questionnaire. The primary outcome is the change in participant melanoma knowledge score before and immediately after completing the melanoma education (the intervention in this study).
1 secondary outcome
Knowledge score three months after completing the educational module
Time frame: 3 months after completing education module
Results and safety
The study was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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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.
Aaron R Mangold 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 Phase 2 study testing Educational Intervention and Questionnaire Administration in people with Melanoma, 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 3 inclusion and 1 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 22 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low/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?
Knowledge score after completing the educational module (time frame: Up to 3 months). 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 22 Jun 2025.