Cigarette Smoking-Related CarcinomaNCT06386432
EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico
A study testing Smartphone App-delivered Smoking Cessation Intervention, Health Promotion and Education and Biospecimen Collection in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. 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-Related Carcinoma
- What is being tested?
- Smartphone App-delivered Smoking Cessation Intervention, Health Promotion and Education and Biospecimen Collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico
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.
Read the detailed 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Smartphone App-delivered Smoking Cessation Intervention, Health Promotion and Education, Biospecimen Collection, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone App-delivered Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Intervention
Receive access to EQQUAL-NM (Program A) intervention
Smartphone App-delivered Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Intervention
Receive access to EQQUAL-NM (Program B) intervention
Health Promotion and EducationOther
Also called Text Message-Based Intervention
Receive text message reminders, motivational messages and prompts via SMS text messages (Program A)
Health Promotion and EducationOther
Also called Text Message-Based Intervention
Receive text message reminders, motivational messages and prompts via SMS text messages (Program B)
Biospecimen CollectionOther
Also called Saliva Sample Collection
Complete at-home saliva sample collection
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (EQQUAL-NM, Program A) | Experimental | Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program A) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. Receives: Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Other: Health Promotion and Education; Other: Biospecimen Collection; Other: Questionnaire Administration |
| Arm II (EQQUAL-NM, Program B) | Active comparator | Participants receive self-guided smartphone app-delivered EQQUAL-NM (Program B) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. Receives: Behavioral: Smartphone App-delivered Smoking Cessation Intervention; Other: Health Promotion and Education; Other: Biospecimen Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3-month follow-up
Number of logins to the assigned application
Server-recorded number of app openings over 3 months
Measured: Up to 3-month follow-up
Secondary outcomes (9)
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
Measured: At 3 months
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
Measured: At 3 months
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
Measured: At 3 months
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
Measured: At 3 months
Self-reported 7-day PPA from cigarette smoking
Self-report of no cigarette smoking over the previous 7 days
Measured: At 3 months
Self-reported 30-day PPA from cigarette smoking
Self-report of no cigarette smoking over the previous 30 days
Measured: At 3 months
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.
Measured: At baseline and at 3-month follow-up
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.
Measured: At baseline and at 3-month follow-up
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.
Measured: At baseline and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Why it stopped: Study never opened to accrual and will not proceed due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Cancer Institute Center to Reduce Cancer Health Disparities, New Mexico State University
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386432
- Sponsor's protocol ID
- RG1124189
- Other IDs
- NCI-2024-02453, FHIRB0020404, U54CA132381
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Tailored, Avatar-Led MHealth Intervention to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults in New Mexico
- ClinicalTrials.gov ID
- NCT06386432
- Acronym / sponsor ID
- RG1124189
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never opened to accrual and will not proceed due to lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Cancer Institute Center to Reduce Cancer Health Disparities, New Mexico State University
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (EQQUAL-NM, Program A) | Experimental | Behavioral: Smartphone App-delivered Smoking Cessation Intervention, Other: Health Promotion and Education, Other: Biospecimen Collection, Other: Questionnaire AdministrationParticipants receive self-guided smartphone app-delivered EQQUAL-NM (Program A) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. |
| Arm II (EQQUAL-NM, Program B) | Active comparator | Behavioral: Smartphone App-delivered Smoking Cessation Intervention, Other: Health Promotion and Education, Other: Biospecimen Collection, Other: Questionnaire AdministrationParticipants receive self-guided smartphone app-delivered EQQUAL-NM (Program B) intervention on study. Participants also receive motivational messages, reminders and smoking cessation information via text messages. Some participants also complete at-home saliva sample collection during follow-up. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone App-delivered Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionReceive access to EQQUAL-NM (Program A) intervention | Behavioural | Arm I (EQQUAL-NM, Program A) |
| Smartphone App-delivered Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionReceive access to EQQUAL-NM (Program B) intervention | Behavioural | Arm II (EQQUAL-NM, Program B) |
| Health Promotion and EducationAlso: Text Message-Based InterventionReceive text message reminders, motivational messages and prompts via SMS text messages (Program A) | Other | Arm I (EQQUAL-NM, Program A) |
| Health Promotion and EducationAlso: Text Message-Based InterventionReceive text message reminders, motivational messages and prompts via SMS text messages (Program B) | Other | Arm II (EQQUAL-NM, Program B) |
| Biospecimen CollectionAlso: Saliva Sample CollectionComplete at-home saliva sample collection | Other | Arm I (EQQUAL-NM, Program A), Arm II (EQQUAL-NM, Program B) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (EQQUAL-NM, Program A), Arm II (EQQUAL-NM, Program B) |
Primary outcome
Participant satisfaction
Time frame: At 3-month follow-up
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.
Number of logins to the assigned application
Time frame: Up to 3-month follow-up
Server-recorded number of app openings over 3 months
9 secondary outcomes
Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products
Time frame: At 3 months
Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products
Time frame: At 3 months
Self-reported 30-day PPA from all nicotine/tobacco products
Time frame: At 3 months
Biochemically confirmed 30-day PPA from all nicotine/tobacco products
Time frame: At 3 months
Self-reported 7-day PPA from cigarette smoking
Time frame: At 3 months
Self-reported 30-day PPA from cigarette smoking
Time frame: At 3 months
Change in Contemplation Ladder scores
Time frame: At baseline and at 3-month follow-up
Change in acceptance of tobacco-use triggers
Time frame: At baseline and at 3-month follow-up
Change in values-guided action
Time frame: At baseline and at 3-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimee Heffner principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone App-delivered Smoking Cessation Intervention, Health Promotion and Education and Biospecimen Collection in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center 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 14 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: withdrawn, as of the sponsor's last update on 8 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Participant satisfaction (time frame: At 3-month follow-up). The study lists 2 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 8 Oct 2025.