Cigarette SmokerNCT03669120
Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking
A study testing Informational Intervention and Telephone-Based Intervention in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker
- What is being tested?
- Informational Intervention and Telephone-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 25 Mar 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female owning a cell phone with a reachable contact number
- Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status
- Smoked at least 100 cigarettes in lifetime
- Currently smoking at least 5 cigarettes a day, on average
- Willing to set a quit smoking date within a week of the enrollment
- English speaking
Who cannot join
- Expired carbon monoxide (CO) levels below 7 ppm
- Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
- Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)
- Pregnant or nursing
- Enrolled in another smoking cessation program
- Partner enrolled on current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities
This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus [vs.] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.
SECONDARY OBJECTIVES:
- To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.
EXPLORATORY OBJECTIVES:
- To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.
ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.
After completion of study, participants are followed up at 3 and 6 months.
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Being tested
- Informational Intervention, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive advice to quit smoking and materials to promote smoking cessation
Telephone-Based InterventionBehavioural
Receive individualized text based messages
| Study group | Role | What they receive |
|---|---|---|
| Arm I (mainstream instructional care) | Active comparator | Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation. Receives: Other: Informational Intervention |
| Arm II (tailored intensive care) | Experimental | Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months. Receives: Other: Informational Intervention; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computing recruitment rate
Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.
Measured: At baseline
Retention rates
Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.
Measured: At 3 and 6 months
Secondary outcomes (3)
Levels of helpfulness
Will be measured by asking: "Were the text messages helpful in your attempt to quit smoking cigarettes?" (Likert scale from 0= Not at all helpful to 4=Very helpful). Will use t-test to compare between arms.
Measured: Up to 6 months
Appropriateness
Will be measured by asking: "Regarding the number of text messages received per day, did you think that there were:" (Likert scale from 0=Too many to 2=Not enough). Will use t-test to compare between arms.
Measured: Up to 6 months
Perceived difficulty
Will be measured by asking: "How easy was it to view the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy) "How easy was it to respond to the text messages?" (Likert scale from 0=Not at all easy to 4=Very easy). Will use t-test to compare between arms.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Aug 2018
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Irene Tami-Maury, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669120
- Sponsor's protocol ID
- 2016-0564
- Other IDs
- NCI-2018-01821, 2016-0564, P30CA016672
- Status last verified
- Apr 2020
- First submitted
- 11 Sep 2018
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored or Non-Tailored Smoking Cessation Intervention for Sexual and Gender Minorities
- ClinicalTrials.gov ID
- NCT03669120
- Acronym / sponsor ID
- 2016-0564
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 13 Sep 2018 (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 studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.
Detailed description
PRIMARY OBJECTIVES:
- To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus [vs.] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.
SECONDARY OBJECTIVES:
- To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.
EXPLORATORY OBJECTIVES:
- To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.
ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.
After completion of study, participants are followed up at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (mainstream instructional care) | Active comparator | Other: Informational InterventionParticipants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of NRT in the form of nicotine patches, and intensive print materials to promote smoking cessation. |
| Arm II (tailored intensive care) | Experimental | Other: Informational Intervention, Behavioral: Telephone-Based InterventionParticipants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female owning a cell phone with a reachable contact number
- Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status
- Smoked at least 100 cigarettes in lifetime
- Currently smoking at least 5 cigarettes a day, on average
- Willing to set a quit smoking date within a week of the enrollment
Key exclusion criteria (6 listed)
- Expired carbon monoxide (CO) levels below 7 ppm
- Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
- Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)
- Pregnant or nursing
- Enrolled in another smoking cessation program
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 |
|---|---|---|
| Informational InterventionReceive advice to quit smoking and materials to promote smoking cessation | Other | Arm I (mainstream instructional care), Arm II (tailored intensive care) |
| Telephone-Based InterventionReceive individualized text based messages | Behavioural | Arm II (tailored intensive care) |
Primary outcome
Computing recruitment rate
Time frame: At baseline
Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.
Retention rates
Time frame: At 3 and 6 months
Will be summarized using descriptive statistics such as the mean, standard deviation, median, interquartile range, and frequency where appropriate. Confidence intervals of 90% for the participating rates at baseline and retention rates at 3- and 6- follow-up will be provided.
3 secondary outcomes
Levels of helpfulness
Time frame: Up to 6 months
Appropriateness
Time frame: Up to 6 months
Perceived difficulty
Time frame: Up to 6 months
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 2 Apr 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Cigarette Smoker
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial
Lung Carcinoma
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
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.
Irene Tami-Maury principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention and Telephone-Based Intervention in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson 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 6 inclusion and 6 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 2 Apr 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.
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?
Computing recruitment rate (time frame: At baseline). 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 2 Apr 2020.