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CompletedNCT02417948Updated Dec 3, 2015

Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans

An interventional study of Written Educational Brochure and Online educational video in Skin Carcinoma and Skin Melanoma, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized clinical trial uses an educational brochure and online tutorial program to assess sun-protective behavior and skin self-examination among African Americans. Skin cancer is very common among African Americans, with a disproportionately high mortality rate. Providing a brochure and an online educational program about sun-protective behaviors may encourage African Americans to take preventative measures against skin cancer, help improve early skin cancer detection, determine how far the disease has spread, and plan the best treatment.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess whether an educational brochure and online program will increase sun-protective behaviors among African-American patients who present at the general dermatology clinic.

SECONDARY OBJECTIVES:

I. To assess whether the educational brochure and online program will improve skills for skin self-examinations among African-American patients who present at the general dermatology clinic.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

ARM II: Participants receive an educational brochure as in Arm I.

After completion of study, participants are followed up at 30 days.

02

Conditions studied

  • Skin Carcinoma
  • Skin Melanoma
03

In context

Melanoma, Cutaneous Malignant

134 studies on the registry are indexed under Melanoma, Cutaneous Malignant; 18 are open to participants now.

This study's enrollment of 143 is above the median of 30 across 98 interventional studies indexed under Melanoma, Cutaneous Malignant.

Browse Melanoma, Cutaneous Malignant studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Self-identified African-Americans who are literate and fluent in English

Exclusion criteria

Exclusion Criteria:

  • Non-African-Americans
  • English illiteracy
  • non-fluency in English
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
143 participants (actual)

Study arms

  • Experimental
    Arm I (educational brochure, online educational tutorial)

    Participants receive a skin cancer educational and preventive brochure distributed by the National Cancer Institute and watch a 30-minute online tutorial video called X-Plain about skin cancer, preventative behaviors, and skin self-examinations.

    Other: Written Educational Brochure · Other: Online educational video

  • Active comparator
    Arm II (educational brochure)

    Participants receive an educational brochure as in Arm I.

    Other: Written Educational Brochure

Interventions

  • OtherWritten Educational Brochure

    Receive brochure with skin cancer education and preventative information

    Also known as: Education for Intervention, Intervention, Educational

  • OtherOnline educational video

    Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations

    Also known as: video intervention, X-Plain

06

What researchers measure

Primary outcomes

  1. Change in sunscreen use among African-American patients

    Change in sun-protective behaviors among African-American patients. Measured by sunscreen use. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

    Time frame: Baseline to day 30

  2. Change in apparel use when exposed to sun among African-American patients

    Change in sun-protective behaviors among African-American patients. Measured by apparel use when exposed to sun. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

    Time frame: Baseline to day 30

  3. Change in frequency of tanning among African-American patients

    Change in sun-protective behaviors among African-American patients. Measured by frequency of tanning. All responses for questions about sun-protective behaviors are on a 5-point Likert scale. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. Treatment scores individuals on the intervention group will be compared. T-tests will be used to compare mean scores for sun-protective behaviors between control and treatment groups.

    Time frame: Baseline to day 30

Secondary outcomes

  1. Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety

    Analyzed by looking at increase or decrease in skin self-examinations the patients report from pre-intervention to post-intervention. Performance of skin self-examination is measured by knowledge, behavior, and anxiety. Most responses for questions about skin self-examinations are on a 5-point Likert scale, while some are yes/no or true/false. Summary scores will be created at baseline and short-term (1 month) follow-up for both control and treatment groups. The outcome variable is a continuous variable. T-tests will be used to compare mean scores for skin self-examinations between groups.

    Time frame: Baseline to day 30

07

Study locations

1 site
  • Case Comprehensive Cancer Center
    Cleveland, Ohio 44106-5065, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02417948
Lead sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 16, 2015
Start date
Apr 2015
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Dec 3, 2015

Study contacts

Jeremy Bordeaux
principal investigator · Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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