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Determinants of Multiple Health Risk Behaviors Among Latinos

15. maj 2019 opdateret af: M.D. Anderson Cancer Center
The goal of this research study is to learn how cultural, environmental, and interpersonal experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among Latino residents of Houston, Texas.

Studieoversigt

Detaljeret beskrivelse

Study Participation:

If you are eligible and choose to take part in this study, you can choose to visit the clinic 2 times or have research staff visit you in your home or a community setting (such as a church or community center) 2 times.

At the first visit (this is the same visit where you complete the in-person screening test):

  • You will have your height, weight, and waistline measured.
  • You will be given a smart phone to take home with you. You will answer questions on the smart phone up to 5 times a day for 7 days. The phone will beep at random times (4 times per day) and set times (in the evening) to prompt you to answer questions about what you are doing and your current thoughts and feelings. These questions should take about 5-7 minutes to complete each time.
  • You will be given an accelerometer (a movement meter). The accelerometer is a small device worn on your hip that measures the amount of physical activity you do. You will wear the accelerometer for 7 days in a row.
  • You will receive training on how to use the smart phone and the accelerometer.

At the second visit, you will return the smart phone and the accelerometer.

At both study visits, you will be asked to complete questionnaires that ask about your feelings, moods, and behaviors. You will complete 36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions). These questionnaires should take about 60 to 90 minutes to complete.

Throughout the study, you will be contacted by mail, email, or telephone for reminders of visits. You will be reminded before each visit. You will be asked to provide the names and contact information for family and/or friends should the study staff have trouble reaching you.

Confidentiality:

Each time you complete a survey on the smart phone, your answers will be saved on the phone. When you return the phone, all of your answers will be downloaded from the phone to a secure server, where they will be stored. Then, all of your information will be deleted from the phone. Your name or other personal information will not be stored on the phone.

Your name and other identifying information will not be stored together in the same files as other information you provide during your participation in the study. The link between your identifying information and other data will be kept in a separate file and securely protected. The link between you and the study data will be destroyed 5 years after the study ends.

Length of Study:

You will be considered off study when you complete the second visit.

This is an investigational study.

Up to 225 participants will take part in this study. All will be enrolled at MD Anderson.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

225

Kontakter og lokationer

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

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson 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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Bilingual Latinos in the Houston, Texas metropolitan area

Beskrivelse

Inclusion Criteria:

  1. Self-identify as Latino in ethnicity
  2. Are between the ages of 18-65, inclusive
  3. Possess a valid home address and functioning telephone number
  4. Possess marginal to adequate health literacy in English (as indicated by a score of at least 45 on the Rapid Estimate of Adult Literacy in Medicine) and Spanish (as indicated by a score of at least 38 on the Short Assessment of Health Literacy for Spanish Adults).

Exclusion Criteria:

  1. Used an illicit substance in the past 30 days
  2. Another household member enrolled in the study
  3. Pregnant or breastfeeding
  4. Participated in a smoking cessation program in the last 90 days
  5. Uses nicotine replacement products
  6. Uses other tobacco products besides cigarettes

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Bilingual Latinos
Bilingual Houston area Latinos surveyed for 7 continuous days with objective and subjective assessments using accelerometer and smart phone.
36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions), taking about 60 to 90 minutes to complete each visit.
Andre navne:
  • Undersøgelser
Small device worn on the hip for 7 consecutive days that measures physical activity.
Andre navne:
  • Movement meter
Questions on smart phone up to 5 times a day for 7 days taking about 5-7 minutes to complete each time.
Andre navne:
  • cell phone

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Determinants of Cancer Risk Behaviors in Latinos
Tidsramme: 7 days
Outcomes assessed through daily diary ecological momentary assessment (EMA) data and coded as yes (engaged in activity) or no (did not engage in activity). EMA assessments done over 7 contiguous days in a questionnaire computer-administered self-interview format.
7 days

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Larkin L. Strong, PHD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 (Faktiske)

1. januar 2012

Primær færdiggørelse (Forventet)

1. januar 2022

Studieafslutning (Forventet)

1. januar 2023

Datoer for studieregistrering

Først indsendt

22. november 2011

Først indsendt, der opfyldte QC-kriterier

23. november 2011

Først opslået (Skøn)

24. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2011-0696
  • 1K01CA157689 (U.S. NIH-bevilling/kontrakt)
  • R25T CA57730 (Registry Identifier: NCI)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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