Communicating Objective Risk for Personalized Decision Making About Mammography
20 juli 2017 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
1560
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 49 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Control group 1: pre/post-test
Group receives pre and post test questions only.
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Experimentell: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information.
(Behavioral: Decision Aid)
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Experimentell: Gail score in a percentage format
Group receives Gail score in a percentage format.
(Behavioral: Decision Aid)
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Experimentell: Gail score in a frequency format
Group receives Gail score in a frequency format.
(Behavioral: Decision Aid)
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Experimentell: 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)
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Experimentell: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography.
(Behavioral: Decision Aid)
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Experimentell: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography.
(Behavioral:Decision Aid)
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Experimentell: 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)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Behavioral intentions to get a mammogram
Tidsram: immediately following intervention (time 0)
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All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
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immediately following intervention (time 0)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Attitude about mammography
Tidsram: immediately following intervention (time 0)
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Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
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immediately following intervention (time 0)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Injunctive and descriptive norms about mammography
Tidsram: immediately following intervention (time 0)
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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.
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immediately following intervention (time 0)
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Decisional satisfaction
Tidsram: immediately following intervention (time 0)
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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."
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immediately following intervention (time 0)
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Risk perception
Tidsram: immediately before and after intervention (time 0)
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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)."
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immediately before and after intervention (time 0)
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Clarity of the information being presented
Tidsram: immediately following intervention (time 0)
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These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
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immediately following intervention (time 0)
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Credibility of the information
Tidsram: immediately following intervention (time 0)
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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?"
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immediately following intervention (time 0)
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Emotional reactions
Tidsram: immediately following intervention (time 0)
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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?"
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immediately following intervention (time 0)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Joseph N Cappella, PhD, University of Pennsylvania
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2012
Primärt slutförande (Faktisk)
18 december 2012
Avslutad studie (Faktisk)
18 december 2012
Studieregistreringsdatum
Först inskickad
28 augusti 2012
Först inskickad som uppfyllde QC-kriterierna
17 september 2012
Första postat (Uppskatta)
18 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2017
Senast verifierad
1 juli 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 816186
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .