Lung CancerNCT00310141
Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
A study testing Smoking cessation intervention, Counseling intervention and Nicotine patch in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking. PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Smoking cessation intervention, Counseling intervention and Nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2002to 30 Aug 2016
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American
- Age 21 to 65 years
- Current Smoker (history of at least 5 cigarettes/day for the last year)
- Motivated to quit within the next 14 days
- Participants must provide a viable home address and functioning home telephone number
- Can speak, read, write in English at a sixth-grade literacy level
- Provide viable collateral contact information
- Register "8" or more on a carbon monoxide breath test
Who cannot join
- Contraindication for nicotine patch use
- Active substance dependence (exclusive of nicotine dependence)
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
- Use of bupropion or nicotine products other than nicotine patches supplied by the study
- Pregnancy or lactation
- Any active illness that precludes full participation in the study protocol
- Another household member enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Treatment of Nicotine Dependence Among African Americans
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.
PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
Read the detailed description
OBJECTIVES:
- Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers.
- Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence.
OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms.
- Arm I (standard care [SC]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date.
- Arm II (computer-delivered treatment [CDT]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date.
All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date.
After completion of study intervention, participants are followed at approximately 6 months.
PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- Smoking cessation intervention, Counseling intervention, Nicotine patch
- Keywords
- non-small cell lung cancer, small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation interventionBehavioural
6 weeks of computer delivered treatment for quitting smoking
Counseling interventionOther
In-person counseling (5 sessions)
Nicotine patchDrug
6-week supply of the nicotine patch
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | Active comparator | Written self-help materials, counseling, and 6-week nicotine patch supply Receives: Other: Counseling intervention; Drug: Nicotine patch |
| Computer Treatment Group (CDT) | Active comparator | Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment Receives: Behavioral: Smoking cessation intervention; Other: Counseling intervention; Drug: Nicotine patch |
| CDT Pilot | Experimental | Written self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment Receives: Behavioral: Smoking cessation intervention; Other: Counseling intervention; Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
Abstinence measures are collected at four post cessation follow-up visits. Point prevalence serving as the primary outcome measure. Primary outcome analyses will use data from all of the follow-up visits. SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings. The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications. The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits.
Measured: 6 months after treatment
Secondary outcomes (1)
Contemplating smoking by Contemplation Ladder 6 months after treatment
The Contemplation Ladder (Biener \& Abrams, 1991) assesses readiness to quit smoking and ranges from 0-10 with 0 being "no thought of quitting" and 10 being "taking action to quit" (e.g., cutting down, enrolling in a program).
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study start8 Apr 2002
- Primary completion17 Aug 2006
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 462 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
- David W. Wetter, PhD, MS, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310141
- Sponsor's protocol ID
- ID01-234
- Other IDs
- R01CA094826, P30CA016672, MDA-ID-01234, CDR0000466339, NCI-2012-01637
- Status last verified
- Aug 2017
- First submitted
- 29 Mar 2006
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nicotine Dependence Among African Americans
- ClinicalTrials.gov ID
- NCT00310141
- Acronym / sponsor ID
- ID01-234
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer, small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2002 (actual)
- Primary completion
- 17 Aug 2006 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 3 Apr 2006 (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.
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking.
PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
Detailed description
OBJECTIVES:
- Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers.
- Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence.
OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms.
- Arm I (standard care [SC]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date.
- Arm II (computer-delivered treatment [CDT]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date.
All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date.
After completion of study intervention, participants are followed at approximately 6 months.
PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Other: Counseling intervention, Drug: Nicotine patchWritten self-help materials, counseling, and 6-week nicotine patch supply |
| Computer Treatment Group (CDT) | Active comparator | Behavioral: Smoking cessation intervention, Other: Counseling intervention, Drug: Nicotine patchWritten self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment |
| CDT Pilot | Experimental | Behavioral: Smoking cessation intervention, Other: Counseling intervention, Drug: Nicotine patchWritten self-help materials, counseling, 6-week nicotine patch supply and 6 weeks of computer-delivered treatment |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- African American
- Age 21 to 65 years
- Current Smoker (history of at least 5 cigarettes/day for the last year)
- Motivated to quit within the next 14 days
- Participants must provide a viable home address and functioning home telephone number
Key exclusion criteria (7 listed)
- Contraindication for nicotine patch use
- Active substance dependence (exclusive of nicotine dependence)
- Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)
- Use of bupropion or nicotine products other than nicotine patches supplied by the study
- Pregnancy or lactation
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 |
|---|---|---|
| Smoking cessation intervention6 weeks of computer delivered treatment for quitting smoking | Behavioural | CDT Pilot, Computer Treatment Group (CDT) |
| Counseling interventionIn-person counseling (5 sessions) | Other | CDT Pilot, Computer Treatment Group (CDT), Standard Care Group |
| Nicotine patch6-week supply of the nicotine patch | Drug | CDT Pilot, Computer Treatment Group (CDT), Standard Care Group |
Primary outcome
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment
Time frame: 6 months after treatment
Abstinence measures are collected at four post cessation follow-up visits. Point prevalence serving as the primary outcome measure. Primary outcome analyses will use data from all of the follow-up visits. SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings. The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications. The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits.
1 secondary outcome
Contemplating smoking by Contemplation Ladder 6 months after treatment
Time frame: 6 months after treatment
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 22 Aug 2017.
- University of Texas MD Anderson Cancer Center Official 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.
David W. Wetter, PhD, MS study chair
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 Smoking cessation intervention, Counseling intervention and Nicotine patch in people with Lung Cancer, 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 8 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 22 Aug 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?
Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment (time frame: 6 months after treatment). 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 22 Aug 2017.