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Communicating Objective Risk for Personalized Decision Making About Mammography

20. juli 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1560

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania

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

35 år til 49 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group 1: pre/post-test
Group receives pre and post test questions only.
Eksperimentel: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information. (Behavioral: Decision Aid)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: Gail score in a percentage format
Group receives Gail score in a percentage format. (Behavioral: Decision Aid)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: Gail score in a frequency format
Group receives Gail score in a frequency format. (Behavioral: Decision Aid)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: 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)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)
Adfærdsmæssigt: Beslutningsstøtte
Eksperimentel: 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)
Adfærdsmæssigt: Beslutningsstøtte

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Joseph N Cappella, PhD, University of Pennsylvania

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. september 2012

Primær færdiggørelse (Faktiske)

18. december 2012

Studieafslutning (Faktiske)

18. december 2012

Datoer for studieregistrering

Først indsendt

28. august 2012

Først indsendt, der opfyldte QC-kriterier

17. september 2012

Først opslået (Skøn)

18. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 816186

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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