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

2. december 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

143

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Case Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Written Educational Brochure
Receive brochure with skin cancer education and preventative information
Andre navne:
  • Uddannelse til intervention
  • Intervention, pædagogisk
Andet: Online educational video
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Andre navne:
  • video intervention
  • X-Plain
Aktiv komparator: Arm II (educational brochure)
Participants receive an educational brochure as in Arm I.
Andet: Written Educational Brochure
Receive brochure with skin cancer education and preventative information
Andre navne:
  • Uddannelse til intervention
  • Intervention, pædagogisk

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in sunscreen use among African-American patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety
Tidsramme: Baseline to day 30
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Case Comprehensive Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Jeremy Bordeaux, Case Comprehensive Cancer Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

13. april 2015

Først indsendt, der opfyldte QC-kriterier

15. april 2015

Først opslået (Skøn)

16. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CASE1615 (Anden identifikator: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH-bevilling/kontrakt)
  • NCI-2015-00481 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner