Tobacco Use CessationNCT01811628
Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers
An observational study of Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to collect information from Latino and Hispanic smokers and recent quitters about factors that are important to them when they are trying to quit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2013to 14 Jul 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited through referrals from community health agencies.
Who may be able to join
- 18+ years of age
- Current smoker (>10 cigarettes per day for the past 3 months) or recently quit Smoking (within the past year) but has not smoked for the past 2 months)
- Read, understand and speak Spanish
- Identify as being of Latino (or Hispanic) heritage, ethnicity, or ancestry.
Who cannot join
- The self-report of a diagnosis of Schizophrenia, Delusional Disorder, Schizoaffective Disorder or Bipolar Disorder in the past year.
- The self-report of a diagnosis of a Substance Dependence Disorder other than Nicotine in the past year (i.e., Alcohol Dependence, Amphetamine Dependence, Cannabis Dependence, Cocaine Dependence, Hallucinogen Dependence, Inhalant Dependence, Opioid Dependence, Phencyclidine Dependence, Sedatives, Hypnotics, or Anxiolytic Dependence, or Polysubstance Dependence)
- Unavailable for a 1.5 hour visit to MD Anderson Cancer Center.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to collect information from Latino and Hispanic smokers and recent quitters about factors that are important to them when they are trying to quit. Researchers want to better understand some of the challenges and problems that Latinos and Hispanics face when they try to quit smoking, and then use that information to design a treatment for future smokers.
Read the detailed description
If participant decides to take part in this study, they will complete a questionnaire about themselves (such as their age, preferred language, and education level) and their smoking habits. This questionnaire should take about 10-15 minutes to complete.
After participant completes this questionnaire, they will be interviewed by a researcher. During this interview participant will be asked to discuss a variety of topics related to smoking and quitting, such as their experience with attempts to quit smoking and problems they may have had. This interview will last about 1 hour.
The interview will be audio-recorded. Participant's interview answers will later be transcribed (written down) without their name or any other identifying information.
Study participation will be complete after the interview.
This is an investigational study.
Up to 48 people will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Tobacco Use Cessation
- Being tested
- Questionnaire, Interview
- Keywords
- Cancer Prevention, Tobacco Use Cessation, Smokers, Recent quitters, Latino, Hispanic, Information, Interview, Questionnaire, Survey, Audio-recorded
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion taking about 10-15 minutes.
InterviewBehavioural
Audio-recorded interview that will last about 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire + Interview | Latinos and Hispanics who are smokers and recent quitters. Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information Collection From Latino and Hispanic Smokers or Recent Quitters
Primary aim of this study is to conduct in-person qualitative interviews with 48 Latino smokers or recent quitters in order to gather information regarding potential elements to include in a future intervention that will target smoking cessation treatment adherence among Latino smokers. This exploratory and qualitative study will utilize thematic analyses of interview discussions to analyze and derive elements that will ultimately be included in a treatment manual.
Data analyzed using thematic analysis, enabling recurring themes from the data presented and discussed and opposing cases highlighted. Analyses facilitated by the use of N*Vivo - a software package package specific to qualitative research. A qualitative analyses of the content of the qualitative interviews conducted separately for current smokers and recent quitters.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study start17 Jul 2013
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 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
- Marcel A. de Dios, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811628
- Sponsor's protocol ID
- 2012-1051
- Other IDs
- K01CA160670
- Status last verified
- Jul 2017
- First submitted
- 11 Mar 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Impact: A Culturally-Tailored Adherence Intervention for Latino Smokers
- ClinicalTrials.gov ID
- NCT01811628
- Acronym / sponsor ID
- 2012-1051
- Conditions
- Tobacco Use Cessation
- Keywords
- Cancer Prevention, Tobacco Use Cessation, Smokers, Recent quitters, Latino, Hispanic, Information, Interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jul 2013 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 14 Mar 2013 (estimated)
- 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.
The goal of this research study is to collect information from Latino and Hispanic smokers and recent quitters about factors that are important to them when they are trying to quit. Researchers want to better understand some of the challenges and problems that Latinos and Hispanics face when they try to quit smoking, and then use that information to design a treatment for future smokers.
Detailed description
If participant decides to take part in this study, they will complete a questionnaire about themselves (such as their age, preferred language, and education level) and their smoking habits. This questionnaire should take about 10-15 minutes to complete.
After participant completes this questionnaire, they will be interviewed by a researcher. During this interview participant will be asked to discuss a variety of topics related to smoking and quitting, such as their experience with attempts to quit smoking and problems they may have had. This interview will last about 1 hour.
The interview will be audio-recorded. Participant's interview answers will later be transcribed (written down) without their name or any other identifying information.
Study participation will be complete after the interview.
This is an investigational study.
Up to 48 people will be enrolled in this study. All will take part at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire + Interview | – | Behavioral: Questionnaire, Behavioral: InterviewLatinos and Hispanics who are smokers and recent quitters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited through referrals from community health agencies.
Key inclusion criteria (4 listed)
- 18+ years of age
- Current smoker (>10 cigarettes per day for the past 3 months) or recently quit Smoking (within the past year) but has not smoked for the past 2 months)
- Read, understand and speak Spanish
- Identify as being of Latino (or Hispanic) heritage, ethnicity, or ancestry.
Key exclusion criteria (3 listed)
- The self-report of a diagnosis of Schizophrenia, Delusional Disorder, Schizoaffective Disorder or Bipolar Disorder in the past year.
- The self-report of a diagnosis of a Substance Dependence Disorder other than Nicotine in the past year (i.e., Alcohol Dependence, Amphetamine Dependence, Cannabis Dependence, Cocaine Dependence, Hallucinogen Dependence, Inhalant Dependence, Opioid Dependence, Phencyclidine Dependence, Sedatives, Hypnotics, or Anxiolytic Dependence, or Polysubstance Dependence)
- Unavailable for a 1.5 hour visit to MD Anderson Cancer Center.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire completion taking about 10-15 minutes. | Behavioural | Questionnaire + Interview |
| InterviewAudio-recorded interview that will last about 1 hour. | Behavioural | Questionnaire + Interview |
Primary outcome
Information Collection From Latino and Hispanic Smokers or Recent Quitters
Time frame: 1 day
Primary aim of this study is to conduct in-person qualitative interviews with 48 Latino smokers or recent quitters in order to gather information regarding potential elements to include in a future intervention that will target smoking cessation treatment adherence among Latino smokers. This exploratory and qualitative study will utilize thematic analyses of interview discussions to analyze and derive elements that will ultimately be included in a treatment manual. Data analyzed using thematic analysis, enabling recurring themes from the data presented and discussed and opposing cases highlighted. Analyses facilitated by the use of N*Vivo - a software package package specific to qualitative research. A qualitative analyses of the content of the qualitative interviews conducted separately for current smokers and recent quitters.
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 18 Jul 2017.
- University of Texas MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Marcel A. de Dios, PHD 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?
An observational study of Tobacco Use Cessation, 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 4 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 18 Jul 2017. 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?
Information Collection From Latino and Hispanic Smokers or Recent Quitters (time frame: 1 day). 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 18 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.