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

NCT02417948 | Completed DMC

• 3 other identifiers: CASE1615NCI-2015-00481P30CA043703
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Carcinoma; Skin Melanoma

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline to day 30

• 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.

  Baseline to day 30

• 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.

  Baseline to day 30

Secondary Outcomes (1)

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

  Baseline to day 30

Study Arms (2)

Arm I (educational brochure, online educational tutorial)

EXPERIMENTAL

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

Arm II (educational brochure)

ACTIVE COMPARATOR

Participants receive an educational brochure as in Arm I.

Other: Written Educational Brochure

Interventions

Written Educational Brochure OTHER

Receive brochure with skin cancer education and preventative information

Also known as: Education for Intervention, Intervention, Educational

Arm I (educational brochure, online educational tutorial); Arm II (educational brochure)

Online educational video OTHER

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

Also known as: video intervention, X-Plain

Arm I (educational brochure, online educational tutorial)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Educational Status; Methods

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Jeremy Bordeaux

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)