Tobacco Use CessationNCT02302859
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study
A study testing Nicotine Patch, Questionnaires and Pamphlet in people with 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 learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking. 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?
- Nicotine Patch, Questionnaires and Pamphlet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18 years of age or older
- Smoked at least 100 cigarettes in lifetime
- English speaking
- HIV-positive patient at Thomas Street Health Center
- Currently smoking 5 or more cigarettes per day
- Willing to make a quit attempt within 1 week of enrollment
Who cannot join
- Positive history of a medical condition that precludes use of the nicotine patch
- Current use of nicotine replacement therapy (NRT)
- Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- Pregnant or nursing
- Enrolled in another smoking cessation study
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Street Health Center -Harris Health System
Houston, Texas, 77009
About this study
Official title: Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study
The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.
Read the detailed description
Baseline Questionnaire:
If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.
Study Groups:
After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.
Both groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.
If you are assigned to Group 1, the following study procedures will be performed:
- You will receive brief advice on how to quit smoking once at the time of enrollment. The advice will be given from a pamphlet that has information such as health problems related to smoking, how many Americans are affected each year, financial problems related to smoking, nicotine replacement therapy options, preparation for quitting smoking, and encouragement to quit.
- On the smart phone, you will have 5 phone counseling sessions for support in quitting smoking throughout the 8-week intervention treatment. The calls should last about 15 minutes.
If you are assigned to Group 2, the following study procedures will be performed:
- On the smart phone, you will receive brief video clips with advice on how to quit smoking, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
- You will also have access to additional counseling content on the smart phone, which you can use at any time.
Weekly Smart Phone Questionnaires:
Both groups will complete questionnaires on the smart phone every week for 8 weeks. Each questionnaire will have questions about your current smoking status, your motivation level to stop smoking, and things that may have a negative effect on your quitting. The questionnaire should take about 15 minutes to complete.
Follow-up Saliva Test and Questionnaire:
About 3 months after your first smart phone intervention, both groups will complete a saliva test and take a photograph of the test results. The saliva test results will be used to check your smoking activity. Supplies and instructions will be given to you when you are enrolled on the study and the instructions will be available on the smart phone. You will also complete a questionnaire similar to the baseline questionnaire.
Length of Study:
You will be on study for about 3 months.
This is an investigational study. Up to 50 participants will take part in this study. All will be enrolled at the Harris Health System (Thomas Street Health Center).
- Conditions
- Tobacco Use Cessation
- Being tested
- Nicotine Patch, Questionnaires, Pamphlet, Phone Counseling Sessions, Saliva Test
- Keywords
- Cancer Prevention, Tobacco Use Cessation, HIV-positive, Nicotine patch, NRT, Questionnaire, Survey, Smartphone, Counseling, Saliva test, Saliva cotinine test, Nicotine replacement therapy, Smoking abstinence, Aids
- Medical subject headings
- Tobacco Use Cessation, HIV Seropositivity, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called NRT
Participants receive an 8 week supply of Nicotine patches.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention.
PamphletOther
Pamphlet given to participant describing health and financial reasons to quit smoking.
Phone Counseling SessionsBehavioural
Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes.
Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
Participants also have access to additional counseling content on the smart phone, which can be used at any time.
Saliva TestOther
Participants complete saliva cotinine test 3 months after intervention.
Smart phoneDevice
Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment (ST) | Experimental | Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention.
Participants complete saliva cotinine test 3 months after intervention. Receives: Drug: Nicotine Patch; Behavioral: Questionnaires; Other: Pamphlet; Behavioral: Phone Counseling Sessions; Other: Saliva Test; Device: Smart phone |
| Automated Treatment (AT) | Experimental | Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone.
Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months.
Participants complete saliva cotinine test 3 months after intervention. Receives: Drug: Nicotine Patch; Behavioral: Questionnaires; Behavioral: Phone Counseling Sessions; Other: Saliva Test; Device: Smart phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence: 3-month Assessment Via Smart Phone
Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: At the request of the PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana S. Hoover, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302859
- Sponsor's protocol ID
- 2014-0509
- Other IDs
- NCI-2014-02572
- Status last verified
- Jan 2020
- First submitted
- 21 Nov 2014
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Smoking Cessation Treatment for Underserved Smokers: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT02302859
- Acronym / sponsor ID
- 2014-0509
- Conditions
- Tobacco Use Cessation
- Keywords
- Cancer Prevention, Tobacco Use Cessation, HIV-positive, Nicotine patch, NRT, Questionnaire, Survey, Smartphone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the request of the PI
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Posted 27 Jan 2020
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 learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.
Detailed description
Baseline Questionnaire:
If you agree to take part in this study, you will complete a questionnaire on a laptop about your feelings, mood, health, thoughts about smoking, thoughts about quitting smoking, smoking history, and some demographic information such as age, education level, and income level. This should take about 15-20 minutes to complete.
Study Groups:
After completing the questionnaire, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being placed in either group.
Both groups will receive smart phones and an 8-week supply of nicotine patches with instructions on how to use them. Each group will receive different methods of advice for quitting smoking.
If you are assigned to Group 1, the following study procedures will be performed:
- You will receive brief advice on how to quit smoking once at the time of enrollment. The advice will be given from a pamphlet that has information such as health problems related to smoking, how many Americans are affected each year, financial problems related to smoking, nicotine replacement therapy options, preparation for quitting smoking, and encouragement to quit.
- On the smart phone, you will have 5 phone counseling sessions for support in quitting smoking throughout the 8-week intervention treatment. The calls should last about 15 minutes.
If you are assigned to Group 2, the following study procedures will be performed:
- On the smart phone, you will receive brief video clips with advice on how to quit smoking, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
- You will also have access to additional counseling content on the smart phone, which you can use at any time.
Weekly Smart Phone Questionnaires:
Both groups will complete questionnaires on the smart phone every week for 8 weeks. Each questionnaire will have questions about your current smoking status, your motivation level to stop smoking, and things that may have a negative effect on your quitting. The questionnaire should take about 15 minutes to complete.
Follow-up Saliva Test and Questionnaire:
About 3 months after your first smart phone intervention, both groups will complete a saliva test and take a photograph of the test results. The saliva test results will be used to check your smoking activity. Supplies and instructions will be given to you when you are enrolled on the study and the instructions will be available on the smart phone. You will also complete a questionnaire similar to the baseline questionnaire.
Length of Study:
You will be on study for about 3 months.
This is an investigational study. Up to 50 participants will take part in this study. All will be enrolled at the Harris Health System (Thomas Street Health Center).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment (ST) | Experimental | Drug: Nicotine Patch, Behavioral: Questionnaires, Other: Pamphlet, Behavioral: Phone Counseling Sessions, Other: Saliva Test, Device: Smart phoneParticipants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention. Participants complete saliva cotinine test 3 months after intervention. |
| Automated Treatment (AT) | Experimental | Drug: Nicotine Patch, Behavioral: Questionnaires, Behavioral: Phone Counseling Sessions, Other: Saliva Test, Device: Smart phoneParticipants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months. Participants complete saliva cotinine test 3 months after intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Smoked at least 100 cigarettes in lifetime
- English speaking
- HIV-positive patient at Thomas Street Health Center
- Currently smoking 5 or more cigarettes per day
Key exclusion criteria (5 listed)
- Positive history of a medical condition that precludes use of the nicotine patch
- Current use of nicotine replacement therapy (NRT)
- Current use of other smoking cessation medications (e.g., Chantix or Zyban)
- Pregnant or nursing
- Enrolled in another smoking cessation study
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 |
|---|---|---|
| Nicotine PatchAlso: NRTParticipants receive an 8 week supply of Nicotine patches. | Drug | Automated Treatment (AT), Standard Treatment (ST) |
| QuestionnairesAlso: SurveysQuestionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention. | Behavioural | Automated Treatment (AT), Standard Treatment (ST) |
| PamphletPamphlet given to participant describing health and financial reasons to quit smoking. | Other | Standard Treatment (ST) |
| Phone Counseling SessionsStandard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes. Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long. Participants also have access to additional counseling content on the smart phone, which can be used at any time. | Behavioural | Automated Treatment (AT), Standard Treatment (ST) |
| Saliva TestParticipants complete saliva cotinine test 3 months after intervention. | Other | Automated Treatment (AT), Standard Treatment (ST) |
| Smart phoneStandard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes. Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. | Device | Automated Treatment (AT), Standard Treatment (ST) |
Primary outcome
Smoking Abstinence: 3-month Assessment Via Smart Phone
Time frame: 3 months
Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Diana S. Hoover, 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?
A study testing Nicotine Patch, Questionnaires and Pamphlet in people with 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jan 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?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Abstinence: 3-month Assessment Via Smart Phone (time frame: 3 months). 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 27 Jan 2020.