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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04812795
Other study ID # 843579
Secondary ID R01CA237670
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2021
Est. completion date June 20, 2022

Study information

Verified date November 2023
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Project RESIST is an R01 study funded by NCI focused on determining the effects of using culturally tailored inoculation approaches to increase resilience to tobacco marketing influences among young adult sexual minority women ages 18-30 and incorporates critical stakeholder inputs that support later adoption and implementation. The study team is utilizing formative research to design and pre-test anti-smoking messages and two national longitudinal online survey experiments.


Description:

This study will recruit 2000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1000) and not current smokers (n=1000). The study team will randomly assign participants to a condition in which they will be exposed to either culturally tailored anti-smoking messages or non-tailored. Participants will receive these messages at baseline and 1, 2, and 3 weeks post baseline. They will be asked to complete a follow-up survey one month post baseline. Intentions to quit smoking as well as intention (among current smokers) and intention to purchase cigarettes (among current nonsmokers) will be measured at baseline and one-month post baseline.


Recruitment information / eligibility

Status Completed
Enrollment 2214
Est. completion date June 20, 2022
Est. primary completion date May 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Ages 18-30 - Woman - Identifies as a sexual minority (any sexual orientation other than heterosexual) - Lives in the United States - Able to take surveys in English Exclusion Criteria: - Under 18 or older than 30 - Men - Heterosexual - Lives outside the United States - Unable to take survey in English

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Culturally tailored anti-smoking messages
Anti-smoking messages that are culturally tailored for sexual minority women.
Non-culturally tailored interventions
Anti-smoking messages that are not culturally tailored for sexual minority women.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania
United States Stanford University Stanford California

Sponsors (7)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine Dana-Farber Cancer Institute, Fenway Community Health, Harvard School of Public Health (HSPH), Michigan State University, National Cancer Institute (NCI), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intention to Quit Smoking Intention to quit smoking will be measured using the Burkhalter intention to quit smoking four item scale that measures readiness to cut down or quit smoking in the next 30 days at baseline and 1 month follow-up.
Participants were asked to rate 4 statements: I will make an effort to quit smoking in the next 30 days (Unlikely to Likely); I intend to quit smoking in the next 30 days (Strongly disagree to Strongly Agree); I expect to quit smoking in the next 30 days (Definitely false to Definitely true); How likely is it that you will quit smoking in the next 30 days (Unlikely to Likely). Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28).
This will only be measured among current smokers. Lowest score is 4 and highest mean score is 28. Higher scores indicate increased intention to quit smoking within the next 30 days.
Day 30
Primary Change in Intention to Purchase Cigarettes The Juster scale was used to measure intention to purchase cigarettes at baseline and at one-month follow-up.
Participants were asked, "How likely are you to purchase cigarettes in the next 6 months?" Responses ranged from 0=No chance, almost no chance (1 in 100) to 10=Certain, practically certain (99 in 100).
Higher values reflect higher intention to purchase.
Day 30
See also
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