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Communicating Objective Risk for Personalized Decision Making About Mammography

20. juli 2017 oppdatert av: University of Pennsylvania
The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.

After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.

After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.

In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.

Studietype

Intervensjonell

Registrering (Faktiske)

1560

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

35 år til 49 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Adult women between the ages of 35 and 49 will be invited to participate in this study.

Exclusion Criteria:

  • Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control group 1: pre/post-test
Group receives pre and post test questions only.
Eksperimentell: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Gail score in a percentage format
Group receives Gail score in a percentage format. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Gail score in a frequency format
Group receives Gail score in a frequency format. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Frequency + Average 50 year old
Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)
Atferdsmessig: Beslutningshjelp
Eksperimentell: Frequency + Avg 50 year old + Mamm Data + Mortality Data
Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography. (Behavioral: Decision Aid)
Atferdsmessig: Beslutningshjelp

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Behavioral intentions to get a mammogram
Tidsramme: immediately following intervention (time 0)
All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
immediately following intervention (time 0)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Attitude about mammography
Tidsramme: immediately following intervention (time 0)
Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
immediately following intervention (time 0)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Injunctive and descriptive norms about mammography
Tidsramme: immediately following intervention (time 0)
Participants will be asked to report their perceived norms about mammography, what they think important others would expect them to do and what they think other women their age or older are doing.
immediately following intervention (time 0)
Decisional satisfaction
Tidsramme: immediately following intervention (time 0)
This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided. Items include, "The information in the decision aid made me feel the choice to get a mammogram is being taken away from me by the groups that make screening recommendations."
immediately following intervention (time 0)
Risk perception
Tidsramme: immediately before and after intervention (time 0)
This variable includes perceived severity and perceived susceptibility of breast cancer. Items include, "What is the chance that an average 40-49 year old woman will develop breast cancer in the next 10 years? Please choose a number between 0 (no chance of breast cancer) and 100 (definitely will get breast cancer)."
immediately before and after intervention (time 0)
Clarity of the information being presented
Tidsramme: immediately following intervention (time 0)
These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
immediately following intervention (time 0)
Credibility of the information
Tidsramme: immediately following intervention (time 0)
These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid. Items include, "How credible did you find the information presented in the decision aid?"
immediately following intervention (time 0)
Emotional reactions
Tidsramme: immediately following intervention (time 0)
The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid. Items include, "How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?"
immediately following intervention (time 0)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Etterforskere

  • Hovedetterforsker: Joseph N Cappella, PhD, University of Pennsylvania

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2012

Primær fullføring (Faktiske)

18. desember 2012

Studiet fullført (Faktiske)

18. desember 2012

Datoer for studieregistrering

Først innsendt

28. august 2012

Først innsendt som oppfylte QC-kriteriene

17. september 2012

Først lagt ut (Anslag)

18. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 816186

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. .

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