EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386432
• Other study ID #: RG1124189
• Secondary ID: NCI-2024-02453RG
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Jaimee Heffner
• Phone: 206-667-7314
• Email: jheffner[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking.

Description:

OUTLINE:

Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program A) that helps explore personal values and teaches participants about smoking triggers and skills to help them manage cravings and accept thoughts and feelings related to smoking. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

GROUP II: Participants receive access to a self-guided, smartphone app-delivered quit smoking program, called EQQUAL-NM (Program B) that is based on current clinical practice guidelines for tobacco cessation to help them quit smoking. This program helps with quit advice, tracking progress on quitting smoking, and managing cravings. Participants receive text message reminders and prompts on study. Some participants also undergo collection of a saliva sample during follow-up.

After completion of study intervention, patients are followed up at 3 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Self-identify being between 18 and 30 years of age

• Self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)

• Currently reside in New Mexico, with a New Mexico mailing address, and anticipate remaining in New Mexico for the duration of the study (3 months)

• Self-report smoking at least 1 cigarette per week in the 30 days prior to screening

• Own an Android phone or iPhone

• Have at least weekly internet access for the next three months

• Willing and able to stream audio and video for this study

• Current use of a personal email account

• Current use of text messaging

• Interested in participating in the study for themselves (versus [vs] someone else)

• Self-report that they have not participated in one of Fred Hutch's/NMSU's prior smoking cessation studies

• Understand and agree to the conditions of compensation

• Currently not incarcerated

• Participants must be willing to use the assigned intervention program, complete the study assessments, and agree to the online consent form in English

Exclusion Criteria:

• Current use of other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)

• Member of the same household as another research participant

• Previous use of the National Cancer Institute (NCI) QuitGuide app

• Google voice number as sole phone number

• Does not pass study fraud prevention protocol

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Smartphone App-delivered Smoking Cessation Intervention
Receive access to EQQUAL-NM (Program A) intervention
• Smartphone App-delivered Smoking Cessation Intervention
Receive access to EQQUAL-NM (Program B) intervention

Other:
• Health Promotion and Education
Receive text message reminders, motivational messages and prompts via SMS text messages (Program A)
• Health Promotion and Education
Receive text message reminders, motivational messages and prompts via SMS text messages (Program B)
• Biospecimen Collection
Complete at-home saliva sample collection
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI), National Cancer Institute Center to Reduce Cancer Health Disparities, New Mexico State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant satisfaction	Self-report of satisfaction overall and with specific program components will be rated on a 5-point Likert-type scale. Higher scale scores indicate higher satisfaction with the app.	At 3-month follow-up
Primary	Number of logins to the assigned application	Server-recorded number of app openings over 3 months	Up to 3-month follow-up
Secondary	Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products	Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications	At 3 months
Secondary	Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 7 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine	At 3 months
Secondary	Self-reported 30-day PPA from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications	At 3 months
Secondary	Biochemically confirmed 30-day PPA from all nicotine/tobacco products	Self-report of no nicotine/tobacco product use over the previous 30 days, with the exception of FDA-approved medications, biochemically confirmed via saliva cotinine	At 3 months
Secondary	Self-reported 7-day PPA from cigarette smoking	Self-report of no cigarette smoking over the previous 7 days	At 3 months
Secondary	Self-reported 30-day PPA from cigarette smoking	Self-report of no cigarette smoking over the previous 30 days	At 3 months
Secondary	Change in Contemplation Ladder scores	Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Ladder scores are on a 0 to 10 scale, with higher change scores meaning greater increases readiness to quit.	At baseline and at 3-month follow-up
Secondary	Change in acceptance of tobacco-use triggers	Change in acceptance of tobacco-use triggers will be measured using the Avoidance and Inflexibility Scale. Higher change scores indicate greater improvement in acceptance of tobacco use triggers.	At baseline and at 3-month follow-up
Secondary	Change in values-guided action	Change in values-guided action measured using the Values Questionnaire. Higher change scores indicate greater improvement in values-guided action.	At baseline and at 3-month follow-up