- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02151032
Using Multimedia Approaches to Communicate Probabilities in Patient Decision Aids for Low-Literacy Populations: Randomized Trial
Studieoversikt
Status
Forhold
Detaljert beskrivelse
If you agree to take part in this study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. Neither you nor the study staff will be able to choose which group you will be in:
- If you are in Group 1, you will read a booklet about colorectal cancer screening tests. While reading the booklet, you will also listen to an audio CD that will narrate the booklet.
- If you are in Group 2, you will watch a video with non-moving images about colorectal cancer screening tests on an iPad.
- If you are in Group 3, you will watch a video with animated images about colorectal cancer screening tests on an iPad.
You will complete questionnaires before and after viewing the program that will contain questions about:
- Your age and what language you speak
- Your math and reading comprehension
- Your knowledge of colorectal cancer and colorectal cancer screening
- Your thoughts about colorectal cancer screening
- Your opinions about this study, and
- How well you understand the booklet/video you view as part of this study
It will take about 1 hour to complete all the questionnaires. In total, the study will take about 1 ½ to 2 hours to complete. After you have completed the questionnaires, your participation in the study will be over.
This is an investigational study.
Up to 201 people will take part in this multicenter study. Up to 67 will be enrolled at MD Anderson.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- University of Texas MD Anderson Cancer Center
-
Houston, Texas, Forente stater, 77042
- Literacy Advance of Houston
-
Houston, Texas, Forente stater, 77035
- Bethel's Heavenly Hands
-
Houston, Texas, Forente stater, 77071
- Ephiphany Community Health Outreach Services
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Men and women 45 to 75 years of age.
- Participant must speak English.
Exclusion Criteria:
1) Self-reported diagnosis of colon cancer.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Colorectal Cancer Screening Booklet + Audio CD
Participants read the booklet about colorectal cancer screening tests, and listen to an audio CD that will narrate the booklet.
Questionnaire completion before and after viewing the program.
|
Participants read a booklet about colorectal cancer screening tests.
Andre navn:
Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.
Questionnaire completion before and after viewing the program.
Andre navn:
|
Video with Non-Moving Images on iPad
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
Questionnaire completion before and after viewing the program.
|
Questionnaire completion before and after viewing the program.
Andre navn:
Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
|
Video with Animated Images on iPad
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
Questionnaire completion before and after viewing the program.
|
Questionnaire completion before and after viewing the program.
Andre navn:
Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Gist and Verbatim Knowledge for a Colorectal Cancer Screening Program
Tidsramme: 1 day
|
The fixed effects analysis of variance (ANOVA) will utilize a factorial design with two factors: content presentation type (standard, animated, interactive) and numeracy status (high and low based on US population scores).
Main dependent measures are gist and verbatim knowledge.
Gist and verbatim knowledge scores (0-100) looked at separately as well as combined.
|
1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Robert Volk, PHD, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Housten AJ, Kamath GR, Bevers TB, Cantor SB, Dixon N, Hite A, Kallen MA, Leal VB, Li L, Volk RJ. Does Animation Improve Comprehension of Risk Information in Patients with Low Health Literacy? A Randomized Trial. Med Decis Making. 2020 Jan;40(1):17-28. doi: 10.1177/0272989X19890296. Epub 2019 Dec 3.
- Housten AJ, Lowenstein LM, Hoover DS, Leal VB, Kamath GR, Volk RJ. Limitations of the S-TOFHLA in measuring poor numeracy: a cross-sectional study. BMC Public Health. 2018 Mar 27;18(1):405. doi: 10.1186/s12889-018-5333-9.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2011-0632
- 0619-1 (Annet stipend/finansieringsnummer: Foundation for Informed Medical Decision Making)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Tykktarmskreft
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk kolorektalt karsinom | Trinn IV tykktarmskreft AJCC v8 | Stage IVA tykktarmskreft AJCC v8 | Stage IVB tykktarmskreft AJCC v8 | Stage IVC Colorectal Cancer AJCC v8Forente stater
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)FullførtTrinn IV tykktarmskreft AJCC v7 | Stage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Kolorektalt adenokarsinom | RAS Wild TypeForente stater
-
Ning JinAktiv, ikke rekrutterendeMetastatisk kolorektalt karsinom | Trinn IV tykktarmskreft AJCC v8 | Stage IVA tykktarmskreft AJCC v8 | Stage IVB tykktarmskreft AJCC v8 | Stage IVC Colorectal Cancer AJCC v8Forente stater
-
University of California, San FranciscoMerck Sharp & Dohme LLCFullførtTrinn IV tykktarmskreft AJCC v7 | Stage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Mikrosatellitt stabil | Trinn III tykktarmskreft AJCC v7 | Trinn IIIB tykktarmskreft AJCC v7 | Stage IIIC tykktarmskreft AJCC v7 | Mismatch Repair Protein dyktigForente stater
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)FullførtTrinn IV tykktarmskreft AJCC v7 | Stage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Tilbakevendende kolorektalt karsinom | Metastatisk karsinom i leverenForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)FullførtTrinn IV tykktarmskreft AJCC v7 | Stage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Metastatisk karsinom i leveren | Resektabel masseForente stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Genentech, Inc.Aktiv, ikke rekrutterendeTrinn IV tykktarmskreft AJCC v7 | Stage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Metastatisk malignt fast neoplasma | Ikke-opererbar fast neoplasma | BRAF NP_004324.2:p.V600X | KRAS wt AllelForente stater
-
M.D. Anderson Cancer CenterRekrutteringMetastatisk malign neoplasma i leveren | Metastatisk kolorektalt karsinom | Trinn IV tykktarmskreft AJCC v8 | Stage IVA tykktarmskreft AJCC v8 | Stage IVB tykktarmskreft AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Resektabelt kolorektalt karsinomForente stater
-
Chloe Atreya, MD, PhDMerck Sharp & Dohme LLC; MedPacto, Inc.RekrutteringMetastatisk malign neoplasma i leveren | Trinn IV tykktarmskreft AJCC v8 | Stage IVA tykktarmskreft AJCC v8 | Stage IVB tykktarmskreft AJCC v8 | Stage IVC Colorectal Cancer AJCC v8Forente stater
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage IVA kolorektal kreft AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Tilbakevendende kolorektalt karsinom | Trinn IIIA tykktarmskreft AJCC v7 | Trinn IIIB tykktarmskreft AJCC v7 | Stage IIIC tykktarmskreft AJCC v7 | Solid neoplasmaForente stater, Canada