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Communicating Objective Risk for Personalized Decision Making About Mammography

20 juli 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

1560

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar tot 49 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control group 1: pre/post-test
Group receives pre and post test questions only.
Experimenteel: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information. (Behavioral: Decision Aid)
Gedragsmatig: Beslissingshulp
Experimenteel: Gail score in a percentage format
Group receives Gail score in a percentage format. (Behavioral: Decision Aid)
Gedragsmatig: Beslissingshulp
Experimenteel: Gail score in a frequency format
Group receives Gail score in a frequency format. (Behavioral: Decision Aid)
Gedragsmatig: Beslissingshulp
Experimenteel: 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)
Gedragsmatig: Beslissingshulp
Experimenteel: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)
Gedragsmatig: Beslissingshulp
Experimenteel: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)
Gedragsmatig: Beslissingshulp
Experimenteel: 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)
Gedragsmatig: Beslissingshulp

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Behavioral intentions to get a mammogram
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Attitude about mammography
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Injunctive and descriptive norms about mammography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

18 december 2012

Studie voltooiing (Werkelijk)

18 december 2012

Studieregistratiedata

Eerst ingediend

28 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2012

Eerst geplaatst (Schatting)

18 september 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2017

Laatst geverifieerd

1 juli 2017

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 816186

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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