Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
2 december 2015 bijgewerkt door: Case Comprehensive Cancer Center
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
143
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106-5065
- Case Comprehensive Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Self-identified African-Americans who are literate and fluent in English
Exclusion Criteria:
- Non-African-Americans
- English illiteracy
- non-fluency in English
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
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Receive brochure with skin cancer education and preventative information
Andere namen:
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Andere namen:
|
|
Actieve vergelijker: Arm II (educational brochure)
Participants receive an educational brochure as in Arm I.
|
Receive brochure with skin cancer education and preventative information
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in sunscreen use among African-American patients
Tijdsspanne: Baseline to day 30
|
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
Tijdsspanne: Baseline to day 30
|
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
Tijdsspanne: Baseline to day 30
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety
Tijdsspanne: Baseline to day 30
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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.
|
Baseline to day 30
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jeremy Bordeaux, Case Comprehensive Cancer Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2015
Primaire voltooiing (Werkelijk)
1 september 2015
Studie voltooiing (Werkelijk)
1 september 2015
Studieregistratiedata
Eerst ingediend
13 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
15 april 2015
Eerst geplaatst (Schatting)
16 april 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
3 december 2015
Laatste update ingediend die voldeed aan QC-criteria
2 december 2015
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CASE1615 (Andere identificatie: Case Comprehensive Cancer Center)
- P30CA043703 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2015-00481 (Register-ID: CTRP (Clinical Trial Reporting Program))
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