- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02417948
Improving Sun-Protective Behaviors and Skin Self-Examinations Among African Americans
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ohio
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Cleveland, Ohio, Stati Uniti, 44106-5065
- Case Comprehensive Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Self-identified African-Americans who are literate and fluent in English
Exclusion Criteria:
- Non-African-Americans
- English illiteracy
- non-fluency in English
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Receive brochure with skin cancer education and preventative information
Altri nomi:
Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
Altri nomi:
|
Comparatore attivo: Arm II (educational brochure)
Participants receive an educational brochure as in Arm I.
|
Receive brochure with skin cancer education and preventative information
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in sunscreen use among African-American patients
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in skin self-examinations among African-American patients as measured by knowledge, behavior and anxiety
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jeremy Bordeaux, Case Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CASE1615 (Altro identificatore: Case Comprehensive Cancer Center)
- P30CA043703 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2015-00481 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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