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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA237670 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Michigan State University | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Stanford University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally tailored (Non-smokers) | Experimental | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
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| Non-culturally tailored (Non-smokers) | Active Comparator | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
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| Culturally Tailored (Smokers) | Experimental | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
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| Non-culturally Tailored (Smokers) | Active Comparator | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally tailored anti-smoking messages | Other | Anti-smoking messages that are culturally tailored for sexual minority women. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Anyone who identifies as a woman, whether they are cisgender or transgender, would meet the gender-based eligibility requirement.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39543185 | Derived | Zulkiewicz BA, Chen JT, Hanby EP, Ramanadhan S, Obedin-Maliver J, Lunn MR, Scout NFN, Gordon B, Applegate J, Machado A, Viswanath K, Potter J, Liu S, Tan ASL. Anti-industry beliefs and attitudes mediate the effect of culturally tailored anti-smoking messages on quit intentions among sexual minority women. Sci Rep. 2024 Nov 15;14(1):28084. doi: 10.1038/s41598-024-78207-7. | |
| 38065403 | Derived | Tan ASL, Chen JT, Keen R, Scout N, Gordon B, Applegate J, Machado A, Hanby E, Liu S, Zulkiewicz B, Ramanadhan S, Obedin-Maliver J, Lunn MR, Viswanath K, Potter J. Culturally Tailored Anti-Smoking Messages: A Randomized Trial With U.S. Sexual Minority Young Women. Am J Prev Med. 2024 May;66(5):840-849. doi: 10.1016/j.amepre.2023.12.001. Epub 2023 Dec 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2023 |
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| OTHER |
| Dana-Farber Cancer Institute | OTHER |
| Fenway Community Health | OTHER |
Participants will be randomly assigned to the tailored or non-tailored arms using random assignment function within survey software.
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| Non-culturally tailored interventions | Other | Anti-smoking messages that are not culturally tailored for sexual minority women. |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| FG001 | Non-culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| FG002 | Culturally Tailored (Smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult sexual minority women. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| FG003 | Non-culturally Tailored (Smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| COMPLETED |
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| NOT COMPLETED |
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U.S. young adult sexual minority women ages 18-30.
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| ID | Title | Description |
|---|---|---|
| BG000 | Culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| BG001 | Non-culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| BG002 | Culturally Tailored (Smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| BG003 | Non-culturally Tailored (Smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Intention to quit smoking | We used a 4-item scale on intention to quit smoking at baseline and at one-month follow-up 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 values indicate greater intention to quit smoking in the next 30 days. | Non-smokers were not asked the questions about intentions to quit smoking. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Intention to purchase cigarettes | We used the Juster scale 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. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | U.S. young adult sexual minority women who smoked at least one cigarette in the past 30 days as baseline. | Posted | Mean | Standard Deviation | Score on a scale | Day 30 |
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| 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. | U.S. young adult sexual minority women who completed the follow-up survey. | Posted | Mean | Standard Deviation | units on a scale | Day 30 |
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1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. | 0 | 501 | 0 | 501 | 0 | 501 |
| EG001 | Non-culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. | 0 | 501 | 0 | 501 | 0 | 501 |
| EG002 | Culturally Tailored (Current Smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. | 0 | 613 | 0 | 613 | 0 | 613 |
| EG003 | Non-culturally Tailored (Current Smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. | 0 | 599 | 0 | 599 | 0 | 599 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andy Tan | University of Pennsylvania | 2157466546 | andy.tan@asc.upenn.edu |
| Aug 17, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2021 | Aug 15, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. |
| OG003 | Non-culturally Tailored (Smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. |
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