search
Back to results

Education for Prevention of Melanoma in Hispanic Populations

Primary Purpose

Melanoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mayo Clinic patients who self-identify as Hispanic or Latino
  • Age 18 and older
  • Have an email on file with Mayo Clinic

Exclusion Criteria:

  • All patients who do not meet inclusion criteria

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (Educational training)

Arm Description

Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 19, 2022
Last Updated
June 16, 2023
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05388851
Brief Title
Education for Prevention of Melanoma in Hispanic Populations
Official Title
Education for Prevention of Melanoma in Hispanic Populations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 reduce risk of and incidence of melanoma and improve cancer survival.
Detailed Description
PRIMARY OBJECTIVES: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (Educational training)
Arm Type
Experimental
Arm Description
Participants complete an educational training module and complete questionnaire at baseline (before educational training module) and 3 months after completing educational training.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Complete educational training module
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Primary Outcome Measure Information:
Title
Knowledge score after completing the educational module
Description
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).
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Knowledge score three months after completing the educational module
Description
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.
Time Frame
3 months after completing education module

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mayo Clinic patients who self-identify as Hispanic or Latino Age 18 and older Have an email on file with Mayo Clinic Exclusion Criteria: All patients who do not meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron R Mangold
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Education for Prevention of Melanoma in Hispanic Populations

We'll reach out to this number within 24 hrs