- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07802054
Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women (MEMO)
Przegląd badań
Status
Szczegółowy opis
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: The Ohio State University Comprehensive Cancer Center
- Numer telefonu: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Lokalizacje studiów
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-
Ohio
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Columbus, Ohio, Stany Zjednoczone, 43210
- The Ohio State University Comprehensive Cancer Center
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Główny śledczy:
- Darren Mays, MPH, PhD
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Kontakt:
- Darren Mays, MPH, PhD
- Numer telefonu: 614-366-2953
- E-mail: Darren.Mays@osumc.edu
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Arm 1: Risk Only + Industry Deception
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Risk message content
Messages with information about alcohol industry deception
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: Arm 4: Efficacy Only + Industry Deception
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Messages with information about alcohol industry deception
Efficacy Message Content
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Eksperymentalny: 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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Eksperymentalny: Arm 6: Efficacy Only + Mechanisms
|
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
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Eksperymentalny: Arm 7: Risk and Efficacy + Industry Deception
|
Risk message content
Messages with information about alcohol industry deception
Efficacy Message Content
|
|
Eksperymentalny: 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
|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Message Perceptions
Ramy czasowe: This assessment is administered immediately after participants view study messages on Day 1
|
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
|
|
Effect Perceptions
Ramy czasowe: 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
Ramy czasowe: This assessment is administered immediately after participants view study messages on Day 1
|
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
|
|
Counter-arguing
Ramy czasowe: This assessment is administered immediately after participants view study messages on Day 1
|
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
Ramy czasowe: 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
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Darren Mays, MPH, PhD, The Ohio State University Comprehensive Cancer Center
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- OSU-26048
- R01CA311193-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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