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Cigarette Smoking BehaviorNCT05499520

Project RESIST: Evaluating the Effects of Anti-smoking Inoculation Messages Among Young Adult Sexual Minority Women

A study testing Culturally Tailored Anti-Smoking Messages in people with Cigarette Smoking Behavior, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking Behavior
What is being tested?
Culturally Tailored Anti-Smoking Messages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,591 participants
Where
1 siteUnited States
Study dates
21 Sep 2022to 15 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Under 18 or older than 30
  • Men
  • Heterosexual
  • Lives outside the United States
  • Unable to take the survey in English

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the detailed description

This study will recruit 3000 young adult sexual minority women (SMW), ages 18-30 years, current smokers (n = 1500) and not current smokers (n = 1500). The study will determine the effects of varying the dose (single vs. multiple), and latency (immediate vs. delayed) of showing participants inoculation anti-smoking messages on smoking and quitting intentions. The study team hypothesize that the multiple exposures (vs. single), and delayed exposure (vs. immediate) will be associated with increased resistance to marketing, reduced smoking intention, and increased quitting intention. The study team will further explore the mechanisms of inoculation effects through emotions, beliefs, and attitudes towards tobacco companies. Participants will be asked to complete a baseline survey and then will receive an anti-smoking message in varying dosages based on the condition they are assigned with a control group receiving no message. Participants will then see a pro-smoking or threat message immediately, one week, or one month late, depending on the condition they were assigned.

Being tested
Culturally Tailored Anti-Smoking Messages
Medical subject headings
Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally Tailored Anti-Smoking MessagesOther

    Anti-smoking messages will be administered online via a Qualtrics survey.

Study groups in NCT05499520
Study groupRoleWhat they receive
Currently Smoking, No Message ConditionNo interventionParticipants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month.
Currently Smoking, Single Message ImmediateExperimentalParticipants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Single Message 1 Week DelayExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Single Message 1 Month DelayExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Single Message 1 Month Delay, Repeated ExposureExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Three Messages ImmediateExperimentalParticipants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Three Messages 1 Week DelayExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Three Messages 1 Month DelayExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Currently Smoking, Three Messages 1 Month Delay Repeat ExposureExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, No Message ConditionNo interventionParticipants will receive no anti-smoking messages. They will receive the threat message during the baseline survey. Outcomes will be measured before and immediately after seeing the threat message, and at 1 month.
Not Currently Smoking, Single Message ImmediateExperimentalParticipants will receive a single anti-smoking message followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking message and threat message, immediately after seeing the threat message, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Single Message 1 Week DelayExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Single Message 1 Month DelayExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking message at baseline, and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Single Message 1 Month Delay, Repeated ExposureExperimentalParticipants will receive a single anti-smoking message during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of a single anti-smoking message at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking message at baseline and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Three Messages ImmediateExperimentalParticipants will receive three anti-smoking messages, followed by the threat message during the baseline survey. Outcomes will be measured before seeing the anti-smoking messages and threat message, immediately after seeing the threat message, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Three Messages 1 Week DelayExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one week later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, immediately after seeing the threat message at 1 week, and at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Three Messages 1 Month DelayExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later in a separate survey. Outcomes will be measured before seeing the anti-smoking messages at baseline, and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages
Not Currently Smoking, Three Messages 1 Month Delay Repeat ExposureExperimentalParticipants will receive three anti-smoking messages during the baseline survey, followed by the threat message one month later. Participants will also receive repeated exposures of three anti-smoking messages at 1, 2, and 3 weeks in separate surveys. Outcomes will be measured before seeing the anti-smoking messages at baseline and immediately after seeing the threat message at 1 month.
Receives: Other: Culturally Tailored Anti-Smoking Messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intention to Quit Smoking at Follow-up

    We used a 4-item scale on intention to quit smoking at baseline and at follow-up (immediate, one-week and one-month) among current smokers only:

    1. I will make an effort to quit smoking in the next 30 days;
    2. I intend to quit smoking in the next 30 days;
    3. I expect to quit smoking in the next 30 days;
    4. How likely is it that you will quit smoking in the next 30 days. Responses ranged on 7-point Likert-like scales. Responses were summed to create a scale for intention to quit (range from 4-28), higher scores indicate higher intention to quit.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

  2. 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.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

  3. Susceptibility to Smoke Cigarettes

    Susceptibility to smoke cigarettes were measured using four-items:

    1. Have you ever been curious about smoking a cigarette?
    2. Do you think you will smoke a cigarette in the next year?
    3. Do you think that you will try a cigarette soon?
    4. If one of your best friends were to offer you a cigarette, would you smoke it? Responses ranged on 4-point Likert-like scales.

    Responses were summed to create a scale for susceptibility to smoke cigarettes (range from 0-12). This was only measured among participants who did not currently smoke.

    Higher scores indicate increased susceptibility to smoke cigarettes.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Secondary outcomes (3)
  1. Receptivity to Marketing

    Receptivity to marketing was measured using 2 items:

    1. Tobacco companies should have the same rights to advertise as other companies.
    2. Are you open to using or wearing something with a tobacco company logo or picture on it? Response options range from 1 (strongly agree) to 5 (strongly disagree)

    The scale is a sum of the responses to these items, the scale ranges from 2 to 10, with lower scores indicating greater receptivity to marketing.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

  2. Tobacco Industry Attitudes

    Tobacco industry attitudes were measured using 3 items:

    1. I would like to see cigarette companies go out of business.
    2. I would not work for a cigarette company.
    3. How much do you like cigarette companies.

    Response options for items 1 and 2 were from 1 (Strongly agree) to 5 (Strongly disagree). Response options for item 3 were from 1 (Dislike strongly) to 5 (Like strongly). Response options were summed across these 3 items to create the tobacco industry attitudes scale.

    Values range from 3 to 15, with lower scores indicating stronger anti-industry sentiment.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

  3. Tobacco Industry Beliefs

    Industry beliefs were measured using 4 items:

    Cigarette companies lie. Cigarette companies target teens to replace smokers who die. Cigarette companies deny that cigarettes cause cancer and other harmful diseases.

    Cigarette companies deny that cigarettes are addictive.

    Response options were from 1 (Strongly agree) to 5 (Strongly disagree).

    Responses were summed across these 4 items to create the tobacco industry beliefs scale. Values ranges from 4 to 20, with lower scores indicating stronger anti-industry sentiment.

    Measured: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start21 Sep 2022
  3. Primary completion5 Jul 2023
  4. Study completion15 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
2,591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499520
Sponsor's protocol ID
11022
Other IDs
R01CA237670
Status last verified
Jul 2024
First submitted
4 Aug 2022
Last updated
31 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Culturally Tailored Anti-Smoking Messages in people with Cigarette Smoking Behavior, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intention to Quit Smoking at Follow-up (time frame: Day [0] reported for No-message, single-message immediate, & 3-messages immediate conditions; Week [1] reported for Single-message & 3-messages 1-week delay conditions; Month [1] reported for Single-message & 3-messages 1-month delay conditions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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