Tobacco Use DisorderPhase 1EQQUALNCT04194918
Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers
A Phase 1 study testing Computer-Assisted Smoking Cessation Intervention, Text Message and Handout in people with Tobacco Use Disorder, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Computer-Assisted Smoking Cessation Intervention, Text Message and Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2020to 1 Sep 2020
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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 and anticipate remaining in the United States for the duration of the study (2 months)
- Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
- Participants must self-report having at least weekly internet access for the next two months
- Participants must self-report being willing and able to stream video online for this study
- Participants must self-report current use of a personal email account
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- Participants must self-report current use of text messaging
- 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 are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
- Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
- 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 in a prison
- Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form
Who cannot join
None listed.
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: A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults
This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.
Read the detailed description
OUTLINE:
Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Participants are followed up with at 2 months.
- Conditions
- Tobacco Use Disorder
- Being tested
- Computer-Assisted Smoking Cessation Intervention, Text Message, Handout, Questionnaire Administration, Quality-of-Life Assessment
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Smoking Cessation InterventionBehavioural
Use the Flexiquit+ program
Text MessageOther
Also called SMS Text, SMS Text Message, Text
Receive text messages
HandoutOther
Receive handouts via email
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (Flexiquit+, text message, handout) | Experimental | Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts. Receives: Behavioral: Computer-Assisted Smoking Cessation Intervention; Other: Text Message; Other: Handout; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment utilization
Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
Measured: Enrollment up to 2 months
Treatment satisfaction: survey
Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
Measured: Enrollment up to 2 months
Secondary outcomes (2)
Smoking cessation rate
Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine.
Measured: At 2 months post-enrollment
Change in motivation to quit smoking
Will be assessed using the Contemplation Ladder.
Measured: From baseline to 2-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 posted11 Dec 2019
- Study start18 May 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Safeway Foundation
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194918
- Sponsor's protocol ID
- RG1004771
- Other IDs
- NCI-2019-08031, P30CA015704, 10396
- Acronym
- EQQUAL
- Status last verified
- Oct 2020
- First submitted
- 9 Dec 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults
- ClinicalTrials.gov ID
- NCT04194918
- Acronym / sponsor ID
- EQQUAL / RG1004771
- Conditions
- Tobacco Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Safeway Foundation
- Study start
- 18 May 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 11 Dec 2019 (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 phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.
Detailed description
OUTLINE:
Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Participants are followed up with at 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Flexiquit+, text message, handout) | Experimental | Behavioral: Computer-Assisted Smoking Cessation Intervention, Other: Text Message, Other: Handout, Other: Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Survey AdministrationIndividuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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 and anticipate remaining in the United States for the duration of the study (2 months)
- Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
- Participants must self-report having at least weekly internet access for the next two months
- Participants must self-report being willing and able to stream video online for this study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Computer-Assisted Smoking Cessation InterventionUse the Flexiquit+ program | Behavioural | Prevention (Flexiquit+, text message, handout) |
| Text MessageAlso: SMS Text, SMS Text Message, TextReceive text messages | Other | Prevention (Flexiquit+, text message, handout) |
| HandoutReceive handouts via email | Other | Prevention (Flexiquit+, text message, handout) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (Flexiquit+, text message, handout) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Prevention (Flexiquit+, text message, handout) |
| Survey AdministrationAncillary studies | Other | Prevention (Flexiquit+, text message, handout) |
Primary outcome
Treatment utilization
Time frame: Enrollment up to 2 months
Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
Treatment satisfaction: survey
Time frame: Enrollment up to 2 months
Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
2 secondary outcomes
Smoking cessation rate
Time frame: At 2 months post-enrollment
Change in motivation to quit smoking
Time frame: From baseline to 2-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 5 Oct 2020.
- 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 Phase 1 study testing Computer-Assisted Smoking Cessation Intervention, Text Message and Handout in people with Tobacco Use Disorder, 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 0 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 5 Oct 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment utilization (time frame: Enrollment up to 2 months). 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 5 Oct 2020.