- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07802054
Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women (MEMO)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Comprehensive Cancer Center
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Ledende efterforsker:
- Darren Mays, MPH, PhD
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Kontakt:
- Darren Mays, MPH, PhD
- Telefonnummer: 614-366-2953
- E-mail: Darren.Mays@osumc.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Assigned female at birth
- Age 18-25
- Report drinking alcohol at least once in the past 30 days
- Registered in the United States as a member of the Prolific consumer research platform
- Willing and able to complete procedures in English
Exclusion Criteria:
- Assigned male at birth
- Ages <18 or >25
- Do not report drinking alcohol at least once in the past 30 days
- Not registered in the U.S. as a member of the Prolific consumer research platform
- Not willing or not able to complete procedures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Arm 1: Risk Only + Industry Deception
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Risk message content
Messages with information about alcohol industry deception
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Eksperimentel: Arm 2: Risk Only + YAW Susceptibility
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Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
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Eksperimentel: Arm 3: Risk Only + Mechanisms
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Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
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Eksperimentel: Arm 4: Efficacy Only + Industry Deception
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Messages with information about alcohol industry deception
Efficacy Message Content
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Eksperimentel: Arm 5: Efficacy Only + YAW Susceptibility
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Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
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Eksperimentel: Arm 6: Efficacy Only + Mechanisms
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Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
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Eksperimentel: Arm 7: Risk and Efficacy + Industry Deception
|
Risk message content
Messages with information about alcohol industry deception
Efficacy Message Content
|
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Eksperimentel: Arm 8: Risk and Efficacy + YAW Susceptibility
|
Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
|
|
Eksperimentel: Arm 9: Risk and Efficacy + Mechanisms
|
Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Message Perceptions
Tidsramme: This assessment is administered immediately after participants view study messages on Day 1
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We will assess message perceptions using a valid, reliable measure with six questions about whether participants thought the messages were worth remembering, grabbed their attention, and were informative, powerful, convincing, and meaningful. Responses are on a five-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean. Higher values are considered a better outcome. |
This assessment is administered immediately after participants view study messages on Day 1
|
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Effect Perceptions
Tidsramme: This assessment is administered immediately after participants view study messages on Day 1
|
We will capture message effects perceptions using the abbreviated effects perceptions scale.
Items include questions about how much the messages made them feel discouraged to drink alcohol, concerned about drinking alcohol, and made them feel that drinking alcohol is unpleasant on a scale from 1 (Strongly disagree) to 5 (Strongly agree).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
|
Emotional Response
Tidsramme: This assessment is administered immediately after participants view study messages on Day 1
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We will capture emotional responses to the messages using a valid, four item scale.
Items are "This message made me angry; irritated; aggravated; and annoyed" with responses on a 5-point Likert scale from 1 (Not likely at all) to 5 (Extremely likely).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
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Counter-arguing
Tidsramme: This assessment is administered immediately after participants view study messages on Day 1
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We will capture counter-arguing, a measure of whether participants cognitively refute messages, with a valid, three item scale that captures whether participants criticize messages, think of points that go against messages, and are skeptical of the messages.
Responses are on a 5-point Likert scale ranging from 1 (Not at all) to 7 (Very much).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Lower values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
|
Behavioral Intentions
Tidsramme: This assessment is administered immediately after participants view study messages on Day 1
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Intentions to reduce alcohol consumption in the future will also be assessed with a valid, multi-item scale capturing whether participants will avoid drinking alcohol completely, reduce the number of occasions when they drink alcohol, and reduce the amount of alcohol they consume on drinking occasions with a 1 (Definitely Will Not) to 4 (Definitely Will) response scale.
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Darren Mays, MPH, PhD, The Ohio State University Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OSU-26048
- R01CA311193-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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