- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07802054
Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women (MEMO)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: The Ohio State University Comprehensive Cancer Center
- Puhelinnumero: 800-293-5066
- Sähköposti: OSUCCCClinicaltrials@osumc.edu
Opiskelupaikat
-
-
Ohio
-
Columbus, Ohio, Yhdysvallat, 43210
- The Ohio State University Comprehensive Cancer Center
-
Päätutkija:
- Darren Mays, MPH, PhD
-
Ottaa yhteyttä:
- Darren Mays, MPH, PhD
- Puhelinnumero: 614-366-2953
- Sähköposti: Darren.Mays@osumc.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Arm 1: Risk Only + Industry Deception
|
Risk message content
Messages with information about alcohol industry deception
|
|
Kokeellinen: Arm 2: Risk Only + YAW Susceptibility
|
Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
|
|
Kokeellinen: Arm 3: Risk Only + Mechanisms
|
Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
|
|
Kokeellinen: Arm 4: Efficacy Only + Industry Deception
|
Messages with information about alcohol industry deception
Efficacy Message Content
|
|
Kokeellinen: Arm 5: Efficacy Only + YAW Susceptibility
|
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
|
|
Kokeellinen: Arm 6: Efficacy Only + Mechanisms
|
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
|
Kokeellinen: Arm 7: Risk and Efficacy + Industry Deception
|
Risk message content
Messages with information about alcohol industry deception
Efficacy Message Content
|
|
Kokeellinen: 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
|
|
Kokeellinen: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Message Perceptions
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: This assessment is administered immediately after participants view study messages on Day 1
|
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
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Darren Mays, MPH, PhD, The Ohio State University Comprehensive Cancer Center
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- OSU-26048
- R01CA311193-01 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .