Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04955 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R00CA260718 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.
PRIMARY OBJECTIVES:
I. Assess the feasibility of delivering mobile multimedia messaging (MMS) anti-tobacco messages developed in the K99 to LGBT young adults via texting.
II. Estimate effect sizes of exposure to anti-tobacco messages on risk perceptions and tobacco use over time.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive AR anti-polytobacco MMS messages 3 times a week (TIW) and a check-in text message once a week (QW) for a total of 6 weeks.
ARM II: Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks.
ARM III: Participants receive control MMS messages on health risks of ultraviolet (UV)/sun exposure TIW and a check-in text message QW for a total of 6 weeks.
All participants also receive smoking cessation resources via email during follow up.
After completion of study intervention, participants are followed up at 6 and 12 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Absolute Risk messages) | Experimental | Participants receive AR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up. |
|
| Arm II (Relative Risk messages) | Experimental | Participants receive RR anti-polytobacco MMS messages TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up. |
|
| Arm III (control messages) | Active Comparator | Participants receive control MMS messages on health risks of UV/sun exposure TIW and a check-in text message QW for a total of 6 weeks. Participants also receive smoking cessation resources via email during follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | Receive control MMS messages |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total tobacco cessation | 2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all. | At 12 weeks post-baseline |
| Acceptability of multimedia messaging service (MMS) anti-polytobacco messages | In a qualitative interview, Participants will be asked the following question: How did you find participating in a study with images sent via text message? How smoothly would you say it went? | At 6-week post-enrollment |
| Feasibility of MMS anti-polytobacco messages | 6 items per study arm. Experimental arms 1 and 2: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding nicotine and tobacco use. Control Group: 6 Yes/No questions (1 per week) checking for engagement with the study content, specifically regarding sun safety. | At 6-weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Switching to exclusive electronic nicotine delivery system (ENDS) use | 2 items. Asks for current use of nicotine vapes and combustible cigarettes Every day, Some days, or Not at all. | At 6- and 12-weeks post-baseline |
| Risk perceptions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne G Patterson | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
Not provided
| Label | URL |
|---|---|
| Our Health Matters | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants are blinded to their randomization category (absolute risks, relative risks, or control)
| Interview |
| Other |
Ancillary studies |
|
| Smoking Cessation Intervention | Behavioral | Receive AR MMS messages |
|
|
| Smoking Cessation Intervention | Behavioral | Receive RR MMS messages |
|
|
| Smoking Cessation Intervention | Behavioral | Receive smoking cessation resources |
|
|
| Survey Administration | Other | Ancillary studies |
|
| Text Message-Based Navigation Intervention | Other | Receive check-in text message |
|
|
3 items. 2 items on a 5 point likert scale where 1= Not at all harmful and 5= Extremely harmful. How harmful do you think nicotine vapes, e-cigarettes, or other electronic products are to health? How harmful do you think cigarettes are to health?; 1 item with 3 response options: Less harmful, About the same, More harmful. Is using nicotine vapes, e-cigarettes or other electronic nicotine products less harmful, about the same, or more harmful than smoking cigarettes?
| At 6- and 12-weeks post-baseline |
| Behavioral intentions | 2 Items. Are you seriously thinking of quitting nicotine vapes? and Are you seriously thinking of quitting cigarettes? 5 response options: Yes, within the next 30 days; Yes, within the next 6 months; Yes, within the next year; Yes, but not within the next year; No, not thinking of quitting. | Difference between conditions in behavioral intentions from screener, and at 6 and 12-week post baseline |
| Serious quit attempts | 2 items. During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? and During the PAST 12 MONTHS, how many times have you stopped vaping nicotine for 1 day or longer because you were trying to quit? 5 response options: None; 1-2 times; 3-5 times; 6-10 times; More than 10 times | Difference between conditions in quit attempts from screener, and at 6 and 12-week post baseline |
| ID | Term |
|---|---|
| D003075 | Coitus |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
Not provided
Not provided
| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided