Cigarette SmokerNCT00948129
Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers
A study testing Laboratory Biomarker Analysis, Smoking Cessation 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 a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker
- What is being tested?
- Laboratory Biomarker Analysis, Smoking Cessation 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
- 626 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2009to 10 Feb 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smoked at least 100 cigarettes in lifetime
- English or Spanish speaking
- Currently smoking at least 5 cigarettes a day, on average
- Willing to set a quit smoking date within a week of the 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.
About this study
Official title: Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.
II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.
III. Compare the cost-effectiveness of the three treatment conditions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.
GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.
GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.
After completion of study, participants are followed up at 3, 6, and 12 months.
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Being tested
- Laboratory Biomarker Analysis, Smoking Cessation Intervention, Telephone-Based Intervention, Tobacco Cessation Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Undergo standard of care smoking cessation intervention
Telephone-Based InterventionBehavioural
Undergo telephone based smoking cessation intervention
Tobacco Cessation CounselingOther
Undergo smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard care) | Active comparator | Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials. Receives: Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention |
| Group II (enhanced care) | Experimental | Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks. Receives: Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention; Other: Tobacco Cessation Counseling |
| Group III (intensive care) | Experimental | Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks. Receives: Other: Laboratory Biomarker Analysis; Behavioral: Smoking Cessation Intervention; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence rate
The primary method of analysis will be mixed-model logistic regression.
Measured: At 12 months
Cost-effectiveness
Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis.
Measured: At 12 months
Secondary outcomes (1)
Salivary cotinine levels
Salivary cotinine will be measured using the NicAlert test system.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study start10 Aug 2009
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 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
- Alexander V Prokhorov, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948129
- Sponsor's protocol ID
- 2009-0336
- Other IDs
- NCI-2018-00260, 2009-0336, R01CA141628
- Status last verified
- Jan 2023
- First submitted
- 14 Jul 2009
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vidrine DJ, Frank-Pearce SG, Vidrine JI, Tahay PD, Marani SK, Chen S, Yuan Y, Cantor SB, Prokhorov AV. Efficacy of Mobile Phone-Delivered Smoking Cessation Interventions for Socioeconomically Disadvantaged Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):167-174. doi: 10.1001/jamainternmed.2018.5713.
PubMed 30556832Daly AT, Deshmukh AA, Vidrine DJ, Prokhorov AV, Frank SG, Tahay PD, Houchen ME, Cantor SB. Cost-effectiveness analysis of smoking cessation interventions using cell phones in a low-income population. Tob Control. 2019 Jan;28(1):88-94. doi: 10.1136/tobaccocontrol-2017-054229. Epub 2018 Jun 9.
PubMed 29886411Vidrine DJ, Fletcher FE, Danysh HE, Marani S, Vidrine JI, Cantor SB, Prokhorov AV. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION. BMC Public Health. 2012 Aug 25;12:696. doi: 10.1186/1471-2458-12-696.
PubMed 22920991
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
- ClinicalTrials.gov ID
- NCT00948129
- Acronym / sponsor ID
- 2009-0336
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Aug 2009 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 29 Jul 2009 (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.
This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.
Detailed description
PRIMARY OBJECTIVES:
- Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.
II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.
III. Compare the cost-effectiveness of the three treatment conditions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.
GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.
GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.
After completion of study, participants are followed up at 3, 6, and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (standard care) | Active comparator | Other: Laboratory Biomarker Analysis, Behavioral: Smoking Cessation InterventionParticipants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials. |
| Group II (enhanced care) | Experimental | Other: Laboratory Biomarker Analysis, Behavioral: Smoking Cessation Intervention, Other: Tobacco Cessation CounselingParticipants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks. |
| Group III (intensive care) | Experimental | Other: Laboratory Biomarker Analysis, Behavioral: Smoking Cessation Intervention, Behavioral: Telephone-Based Intervention, Other: Tobacco Cessation CounselingParticipants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Smoked at least 100 cigarettes in lifetime
- English or Spanish speaking
- 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 (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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (standard care), Group II (enhanced care), Group III (intensive care) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsUndergo standard of care smoking cessation intervention | Behavioural | Group I (standard care), Group II (enhanced care), Group III (intensive care) |
| Telephone-Based InterventionUndergo telephone based smoking cessation intervention | Behavioural | Group III (intensive care) |
| Tobacco Cessation CounselingUndergo smoking cessation counseling | Other | Group II (enhanced care), Group III (intensive care) |
Primary outcome
Smoking abstinence rate
Time frame: At 12 months
The primary method of analysis will be mixed-model logistic regression.
Cost-effectiveness
Time frame: At 12 months
Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis.
1 secondary outcome
Salivary cotinine levels
Time frame: At 12 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 20 Jan 2023.
- Derived from this study: PubMed 30556832Vidrine DJ, Frank-Pearce SG, Vidrine JI, Tahay PD, Marani SK, Chen S, Yuan Y, Cantor SB, Prokhorov AV. Efficacy of Mobile Phone-Delivered Smoking Cessation Interventions for Socioeconomically Disadvantaged Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):167-174. doi: 10.1001/jamainternmed.2018.5713.
- Derived from this study: PubMed 29886411Daly AT, Deshmukh AA, Vidrine DJ, Prokhorov AV, Frank SG, Tahay PD, Houchen ME, Cantor SB. Cost-effectiveness analysis of smoking cessation interventions using cell phones in a low-income population. Tob Control. 2019 Jan;28(1):88-94. doi: 10.1136/tobaccocontrol-2017-054229. Epub 2018 Jun 9.
- Derived from this study: PubMed 22920991Vidrine DJ, Fletcher FE, Danysh HE, Marani S, Vidrine JI, Cantor SB, Prokhorov AV. A randomized controlled trial to assess the efficacy of an interactive mobile messaging intervention for underserved smokers: Project ACTION. BMC Public Health. 2012 Aug 25;12:696. doi: 10.1186/1471-2458-12-696.
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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.
Alexander V Prokhorov 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 Laboratory Biomarker Analysis, Smoking Cessation 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 4 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: finished, as of the sponsor's last update on 20 Jan 2023. 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?
Smoking abstinence rate (time frame: At 12 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?
On the ClinicalTrials.gov record for NCT00948129, which also lists 3 linked publications.
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 20 Jan 2023.