Cigarette Smoking-Related CarcinomaNCT05847673
Avatar-Led Digital Therapeutic for Aiding Smoking Cessation in Sexual and Gender Minority Young Adults
A study testing Online Smoking Cessation Intervention, Questionnaire Administration and Health Promotion and Education in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. 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?
- Online Smoking Cessation Intervention, Questionnaire Administration and Health Promotion and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2023to 13 Jun 2024
- 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
- DEMOGRAPHIC CRITERIA:
- Participants must self-identify being between 18 and 30 years of age
- Participants must 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)
- Participants must currently reside in the United States, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months)
- SMOKING CRITERIA:
- Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
Show all 19Show fewer
- TREATMENT ACCESSIBILITY:
- Participants must self-report having at least weekly Internet access for the next three months
- Participants must self-report being willing and able to stream audio and video online for this study
- Participants must self-report current use of a personal email account
- Participants must self-report current use of text messaging
- OTHER CRITERIA:
- Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
- Participants must self-report that they have not participated in one of our prior smoking cessation studies
- Participants must self-report that they are comfortable reading, writing, and speaking English
- Participants must self-report that they understand and agree to the conditions of compensation
- Participants must self-report that they are not currently incarcerated
- Participants must be willing to use the assigned intervention program, complete the study assessments, and consent to participate in this study
- Participants must be willing to upload a photo of themselves (face visible)
Who cannot join
- Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
- Participants must not be a member of the same household as another research participant
- Having a Google voice number as their sole phone number
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: Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults
This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.
Read the detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.
ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Online Smoking Cessation Intervention, Questionnaire Administration, Health Promotion and Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Intervention
Receive EQQUAL A intervention
Online Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Intervention
Receive EQQUAL B intervention
Questionnaire AdministrationOther
Ancillary studies
Health Promotion and EducationOther
Receive motivational messages and smoking cessation information via SMS text messages
| Study group | Role | What they receive |
|---|---|---|
| Arm I (EQQUAL A) | Experimental | Participants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages. Receives: Behavioral: Online Smoking Cessation Intervention; Other: Questionnaire Administration; Other: Health Promotion and Education |
| Arm II (EQQUAL B) | Active comparator | Participants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages. Receives: Behavioral: Online Smoking Cessation Intervention; Other: Questionnaire Administration; Other: Health Promotion and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction
Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of "mostly satisfied" or "very satisfied" versus all other responses (i.e., "not at all," "a little," and "somewhat"). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Measured: At 3-month follow-up
Average change in Contemplation Ladder scores
Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Measured: Baseline through 3-month follow-up
Reduction in cigarettes smoked per day
Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Measured: Baseline through 3-month follow-up
7-day point prevalence abstinence (PPA) from all nicotine and tobacco use
Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Measured: At 3-month follow-up
Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program
Measured by the System Usability Scale. Will be presented descriptively as an average usability score.
Measured: At 3-month follow-up
Acceptability of the EQQUAL avatar
Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages.
Measured: At 3-month follow-up
Number of EQQUAL sessions completed
Will be presented descriptively as frequencies and percentages.
Measured: Up to 3 months
Secondary outcomes (5)
Changes in the acceptance of smoking triggers
Assessed by the emotional and physical subscales of the Avoidance and Inflexibility Scale (AIS). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.
Measured: Baseline through 3-month follow-up
Changes in psychological flexibility
Assessed by the short version of the Multidimensional Psychological Flexibility Inventory (MPFI). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.
Measured: Baseline through 3-month follow-up
Changes in valued living
Assessed by the Valuing Questionnaire. Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.
Measured: Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit
Will be presented descriptively as frequencies and percentages.
Measured: Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't
Will be presented descriptively as frequencies and percentages.
Measured: Baseline through 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 posted8 May 2023
- Study start20 Aug 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Leonard and Norma Klorfine Foundation
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847673
- Sponsor's protocol ID
- RG1123270
- Other IDs
- NCI-2023-03050, RG1123270
- Status last verified
- Jul 2024
- First submitted
- 27 Apr 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heffner JL, Baker K, Fan X, Kelly MM, Orzechowski M, Ruiz RA, Scout NFN, Serfozo E, Stimatze T, Karekla M. Avatar-led digital health intervention for sexual and gender minority young adult smoking cessation: randomized controlled pilot trial. Nicotine Tob Res. 2026 Oct 22;28(11):1901-1911. doi: 10.1093/ntr/ntag113.
PubMed 42166213
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults
- ClinicalTrials.gov ID
- NCT05847673
- Acronym / sponsor ID
- RG1123270
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- The Leonard and Norma Klorfine Foundation
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 8 May 2023 (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 trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.
ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.
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 A) | Experimental | Behavioral: Online Smoking Cessation Intervention, Other: Questionnaire Administration, Other: Health Promotion and EducationParticipants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages. |
| Arm II (EQQUAL B) | Active comparator | Behavioral: Online Smoking Cessation Intervention, Other: Questionnaire Administration, Other: Health Promotion and EducationParticipants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- DEMOGRAPHIC CRITERIA:
- Participants must self-identify being between 18 and 30 years of age
- Participants must 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)
- Participants must currently reside in the United States, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months)
- SMOKING CRITERIA:
Key exclusion criteria (3 listed)
- Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
- Participants must not be a member of the same household as another research participant
- Having a Google voice number as their sole phone number
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 |
|---|---|---|
| Online Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionReceive EQQUAL A intervention | Behavioural | Arm I (EQQUAL A) |
| Online Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionReceive EQQUAL B intervention | Behavioural | Arm II (EQQUAL B) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (EQQUAL A), Arm II (EQQUAL B) |
| Health Promotion and EducationReceive motivational messages and smoking cessation information via SMS text messages | Other | Arm I (EQQUAL A), Arm II (EQQUAL B) |
Primary outcome
Overall satisfaction
Time frame: At 3-month follow-up
Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of "mostly satisfied" or "very satisfied" versus all other responses (i.e., "not at all," "a little," and "somewhat"). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Average change in Contemplation Ladder scores
Time frame: Baseline through 3-month follow-up
Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Reduction in cigarettes smoked per day
Time frame: Baseline through 3-month follow-up
Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
7-day point prevalence abstinence (PPA) from all nicotine and tobacco use
Time frame: At 3-month follow-up
Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).
Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program
Time frame: At 3-month follow-up
Measured by the System Usability Scale. Will be presented descriptively as an average usability score.
Acceptability of the EQQUAL avatar
Time frame: At 3-month follow-up
Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages.
Number of EQQUAL sessions completed
Time frame: Up to 3 months
Will be presented descriptively as frequencies and percentages.
5 secondary outcomes
Changes in the acceptance of smoking triggers
Time frame: Baseline through 3-month follow-up
Changes in psychological flexibility
Time frame: Baseline through 3-month follow-up
Changes in valued living
Time frame: Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit
Time frame: Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't
Time frame: Baseline through 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 42166213Heffner JL, Baker K, Fan X, Kelly MM, Orzechowski M, Ruiz RA, Scout NFN, Serfozo E, Stimatze T, Karekla M. Avatar-led digital health intervention for sexual and gender minority young adult smoking cessation: randomized controlled pilot trial. Nicotine Tob Res. 2026 Oct 22;28(11):1901-1911. doi: 10.1093/ntr/ntag113.
- 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 Online Smoking Cessation Intervention, Questionnaire Administration and Health Promotion and Education 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 19 inclusion and 3 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 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall satisfaction (time frame: At 3-month follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847673, which also lists 1 linked publication.
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 19 Jul 2024.