Smoking CessationNCT01310842
Social Determinants and Smoking Cessation
An observational study of Smoking Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to learn about the influence of the social and physical environment on smoking cessation (quitting smoking) among smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Questionnaires, Nicotine Patch Therapy and Counseling Sessions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Current smoker, age 18 years or above, with a history of at least 5 cigarettes/day for the last year and resides in Houston, Texas.
Who may be able to join
- 18 and above
- Current smoker with a history of at least 5 cigarettes/day for the last year (participant must register a CO level of 8 or higher)
- Motivated to quit within the next 30 days
- Valid home address reflective of residence in Houston
- Functioning telephone number
- Can speak, read, and write in English
- Marginal or adequate health literacy
Who cannot join
- Contraindication for nicotine patch use
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
- Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
- Pregnancy or lactation
- Another household member is enrolled in this protocol
- Active substance abuse problem
- Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
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 study is to learn about the influence of the social and physical environment on smoking cessation (quitting smoking) among smokers.
Read the detailed description
If you agree to take part in this study, you will receive help to quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch. Over the next 6 months, you will visit MD Anderson 7 times.
Study Visits:
Your first visit is the "baseline" visit when you enter the study. You will then attend 6 additional in-person visits: Week 0 (1 week after the baseline visit), Week 1, Week 2, Week 3, Week 12, and Week 26.
During the baseline visit you will receive a small, hand-held personal phone and be trained in how to use it. You will carry this phone with you for 4 weeks. You will use the phone to answer questions about your mood, stress, and smoking-related issues. You will be asked to fill out some questions on the phone each time you have an urge to smoke. Also, the phone will "beep" at random and set times and ask that you answer some questions. This phone will not wake you during the night and you will be able to wait to answer questions for a few minutes if it goes off when you are busy. Answering the questions should take about 5-10 minutes. This small, hand-held personal phone will also have a GPS system activated that will record where you are during the waking hours every day while you are on study.
Study Tests:
The following tests and procedures will be performed at each study visit:
- You will complete some questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60-90 minutes to complete.
- You will complete a breath test to help estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to the machine, and you blow a long, slow, steady breath into it.
- At the baseline, Week 12, and Week 26 visits, you will have saliva samples collected for cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton in your mouth for a few minutes. These samples will be used to measure the amount of cotinine in your saliva. Cotinine is a chemical released in your body when it breaks down nicotine.
- You will have your height, weight, and waistline measured.
You may be contacted by mail, telephone, and/or e-mail during the study to be given reminders of clinic visits. You will be asked to provide the names and contact information for family and/or friends for the study staff to contact if the study staff has trouble reaching you.
Length of Study:
You will be considered off study when you complete the Week 26 visit.
After you return the phone and GPS, all of your information that is stored on the devices will be erased. After the information is erased from the devices, it cannot be retrieved.
This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available. You will receive 4 weeks of nicotine patches.
Up to 300 smokers will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires, Nicotine Patch Therapy, Counseling Sessions
- Keywords
- Smoker, Smoking Cessation, Social Determinants, Environmental Effects, Individual-level effects, Nicotine patch, Smart Phone, SP, Global Positioning System, GPS, Questionnaires, Saliva samples
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Survey
Questionnaires completed at each study visit, taking 60-90 minutes, in addition to 4 Smart Phone initiated assessments per day during waking hours, taking about 5-10 minutes.
Nicotine Patch TherapyDrug
4 weeks of nicotine patch therapy
Counseling SessionsBehavioural
5 or 7 in person counseling sessions on smoking cessation: Baseline, Week 0/Quit Date (1 week following the baseline visit), Week 1, Week 2, Week 3 for Pilot Group and additional sessions Week 12 and Week 26 for other group.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Smoking Cessation | 4 weeks nicotine patch therapy, self-help materials, and 5 in-person counseling sessions. Receives: Behavioral: Questionnaires; Drug: Nicotine Patch Therapy; Behavioral: Counseling Sessions | |
| Smoking Cessation | 4 weeks nicotine patch therapy, self-help materials, and 7 in-person counseling sessions. Receives: Behavioral: Questionnaires; Drug: Nicotine Patch Therapy; Behavioral: Counseling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of Social and Physical Environment on Smoking Cessation Among Smokers
Participants followed from 2 weeks prior to quit date through 26 weeks after quit date, assessed for 4 contiguous weeks (1 week precessation through 3 weeks postcessation) using state-of-the-science ecological momentary assessment (EMA) and global positioning system (GPS) procedures.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startJul 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Larkin L. Strong, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310842
- Sponsor's protocol ID
- 2010-0950
- Other IDs
- RP110025, 1K99MD010468-01
- Status last verified
- Oct 2016
- First submitted
- 21 Feb 2011
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants and Smoking Cessation
- ClinicalTrials.gov ID
- NCT01310842
- Acronym / sponsor ID
- 2010-0950
- Conditions
- Smoking Cessation
- Keywords
- Smoker, Smoking Cessation, Social Determinants, Environmental Effects, Individual-level effects, Nicotine patch, Smart Phone, SP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jul 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Mar 2011 (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 study is to learn about the influence of the social and physical environment on smoking cessation (quitting smoking) among smokers.
Detailed description
If you agree to take part in this study, you will receive help to quit smoking, including written self-help materials, counseling, and a supply of the nicotine patch. Over the next 6 months, you will visit MD Anderson 7 times.
Study Visits:
Your first visit is the "baseline" visit when you enter the study. You will then attend 6 additional in-person visits: Week 0 (1 week after the baseline visit), Week 1, Week 2, Week 3, Week 12, and Week 26.
During the baseline visit you will receive a small, hand-held personal phone and be trained in how to use it. You will carry this phone with you for 4 weeks. You will use the phone to answer questions about your mood, stress, and smoking-related issues. You will be asked to fill out some questions on the phone each time you have an urge to smoke. Also, the phone will "beep" at random and set times and ask that you answer some questions. This phone will not wake you during the night and you will be able to wait to answer questions for a few minutes if it goes off when you are busy. Answering the questions should take about 5-10 minutes. This small, hand-held personal phone will also have a GPS system activated that will record where you are during the waking hours every day while you are on study.
Study Tests:
The following tests and procedures will be performed at each study visit:
- You will complete some questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60-90 minutes to complete.
- You will complete a breath test to help estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to the machine, and you blow a long, slow, steady breath into it.
- At the baseline, Week 12, and Week 26 visits, you will have saliva samples collected for cotinine tests. To collect the saliva, you will be asked to put a small piece of cotton in your mouth for a few minutes. These samples will be used to measure the amount of cotinine in your saliva. Cotinine is a chemical released in your body when it breaks down nicotine.
- You will have your height, weight, and waistline measured.
You may be contacted by mail, telephone, and/or e-mail during the study to be given reminders of clinic visits. You will be asked to provide the names and contact information for family and/or friends for the study staff to contact if the study staff has trouble reaching you.
Length of Study:
You will be considered off study when you complete the Week 26 visit.
After you return the phone and GPS, all of your information that is stored on the devices will be erased. After the information is erased from the devices, it cannot be retrieved.
This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available. You will receive 4 weeks of nicotine patches.
Up to 300 smokers will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Smoking Cessation | – | Behavioral: Questionnaires, Drug: Nicotine Patch Therapy, Behavioral: Counseling Sessions4 weeks nicotine patch therapy, self-help materials, and 5 in-person counseling sessions. |
| Smoking Cessation | – | Behavioral: Questionnaires, Drug: Nicotine Patch Therapy, Behavioral: Counseling Sessions4 weeks nicotine patch therapy, self-help materials, and 7 in-person counseling sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Current smoker, age 18 years or above, with a history of at least 5 cigarettes/day for the last year and resides in Houston, Texas.
Key inclusion criteria (7 listed)
- 18 and above
- Current smoker with a history of at least 5 cigarettes/day for the last year (participant must register a CO level of 8 or higher)
- Motivated to quit within the next 30 days
- Valid home address reflective of residence in Houston
- Functioning telephone number
Key exclusion criteria (7 listed)
- Contraindication for nicotine patch use
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
- Use of nicotine replacement therapy products or other smoking cessation medications, other than the nicotine patches supplied during the study
- Pregnancy or lactation
- Another household member is enrolled in this 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 |
|---|---|---|
| QuestionnairesAlso: SurveyQuestionnaires completed at each study visit, taking 60-90 minutes, in addition to 4 Smart Phone initiated assessments per day during waking hours, taking about 5-10 minutes. | Behavioural | Pilot Smoking Cessation, Smoking Cessation |
| Nicotine Patch Therapy4 weeks of nicotine patch therapy | Drug | Pilot Smoking Cessation, Smoking Cessation |
| Counseling Sessions5 or 7 in person counseling sessions on smoking cessation: Baseline, Week 0/Quit Date (1 week following the baseline visit), Week 1, Week 2, Week 3 for Pilot Group and additional sessions Week 12 and Week 26 for other group. | Behavioural | Pilot Smoking Cessation, Smoking Cessation |
Primary outcome
Influence of Social and Physical Environment on Smoking Cessation Among Smokers
Time frame: 3 weeks
Participants followed from 2 weeks prior to quit date through 26 weeks after quit date, assessed for 4 contiguous weeks (1 week precessation through 3 weeks postcessation) using state-of-the-science ecological momentary assessment (EMA) and global positioning system (GPS) procedures.
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 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Smoking Cessation
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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.
Larkin L. Strong, 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 Smoking 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 7 inclusion and 7 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 2016. 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?
Influence of Social and Physical Environment on Smoking Cessation Among Smokers (time frame: 3 weeks). 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 2016; AzTrials last refreshed its copy on 30 Oct 2026.