Tobacco UsePhase 3QWIThelperNCT00311948
Telephone and Web-based Teen Tobacco Cessation in HMOs
A Phase 3 study testing Telephone counseling + interactive website = more abstinence and Behavioral: interactive website in people with Tobacco Use, run by Kaiser Permanente at 3 sites in United States.
Trial summary
The purpose of this study is to look at both the clinicians' ability to reach out to the teen smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Telephone counseling + interactive website = more abstinence and Behavioral: interactive website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Apr 2010
- Phase
- Phase 3
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-18 years old
- both males and females
- smoking cigarettes at least four days a month
- some interest in quitting (will take all teen regardless of stage of readiness
- no evidence of treatment for depression, alcohol, or drugs in last year
- must consent
Show all 9Show fewer
- have physician's approval for outreach to their panel
- have (or able to get) Internet access and phone access
- willingness to participate in study and follow-up procedures.
Who cannot join
- <15 years old
- >18 years old
- treated within 1 year for depression, alcohol, or drugs
- No internet access or phone access
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Oregon Research Institute
Eugene, Oregon, 97403
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Free & Clear, Inc.
Seattle, Washington, 98104
About this study
The purpose of this study is to look at both the clinicians' ability to reach out to the teen smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment.
Read the detailed description
Health maintenance organizations have the mission, incentive, communication tools, and credibility with patients to reach out to teen members who use tobacco. The overall aim of this project is to refine and test both the potential reach and the efficacy of tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment. As part of a clinician-directed outreach effort, we will work closely with pediatric clinicians to maximize the program's reach into the teen smoker population as identified through the electronic data base of a large HMO. We will use letters and proactive outreach calls to assess current smoking status and recruit 600 15- to 18-year-old teen smokers who are interested in quitting and would be willing to receive cessation support via telephone and the Web. A second aim will be to randomly assign interested teen smokers to receive a proactive telephone- and Web-based tobacco cessation program or access to a website with cessation materials (control condition) to test the efficacy of the program on long-term cessation rates at 6- and 12-months. We will use several process measures to assess our ability to implement and consistently deliver both the telephone and Web components of the intervention. We will measure mediating variables to determine they support the hypothesized linkages between the theoretical constructs described by our cognitive behavioral model of action. An effective managed care partnership with clinicians to assess, recruit, and intervene with teen smokers would be of great interest to clinicians and health plan managers, highly exportable, and would be given high priority for implementation at the population level.
Our specific aims are as follows:
- Compare the population-based recruitment yields and costs of three proactive outreach approaches: 1) outreach calls only to those teen smokers who are seen, advised, and referred to us by their clinician; 2) outreach calls to a random sample of teens shown as being smokers in the EMR; and 3) outreach calls to a sample of all teens
- Assess efficacy/effectiveness in a randomized trial with 600 teen smokers to evaluate the hypothesis that proactive telephone-based counseling integrated with an interactive website will increase 6- and 12-month abstinence rates (30-day point prevalence) relative to a control condition receiving mailed cessation materials alone
- Assess the hypothesis that the telephone and web-based intervention will improve longer-term maintenance of abstinence at an 12-month follow-up point compared to the control condition
- Describe use patterns for key intervention process measures (e.g., calls completed, use of website) and determine if intervention affects outcome through theoretical mediators (e.g., pros/cons, stage, efficacy)
- Determine the total costs of the telephone and web-based program from the perspective of the HMO and replication costs in other settings, and report costs as incremental costs per member per month, per program participant, and per quit.
- Conditions
- Tobacco Use
- Being tested
- Telephone counseling + interactive website = more abstinence, Behavioral: interactive website
- Keywords
- Teen smokers, Quithelper, Tobacco, Tobacco Website, Website Intervention, Tobacco counseling, Tobacco abstinence
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counseling + interactive website = more abstinenceBehavioural
Behavioral: interactive websiteBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone counseling + interactive website | Active comparator | Teen has access to interactive website and receives tailored telephone counseling Receives: Behavioral: Telephone counseling + interactive website = more abstinence |
| Control with interactive website | Other | Teen only has access to interactive website. Receives: Behavioral: Behavioral: interactive website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.
self report of smoking in last 30 days
Measured: 6 months and 12 months
12-month measure to determine long-term assessment
Self report smoking or not smoking.
Measured: 12-months
Secondary outcomes (7)
A six-month assessment to determine short-term effects
Measured: 6 months
Assess the prevalence of smoking on 25 or more days per month
Measured: 1 month
Assess sustained abstinence (e.g., three and six months) at each follow-up,
No smoking - yes or no at 3 month timeframe and 6 months timeframe
Measured: 3 months and 6 months
Assess change in stage of change
Measured: 6 months and 12 months
Assess amount smoked, and use of other tobacco products (including smokeless tobacco) in the last week, 30 days, three months, and six months prior to the follow-up assessment.
Measured: 30 days, 6 months, 12 months
Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach
Measured: 1 day
Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (100)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jack F Hollis, Ph.D., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311948
- Sponsor's protocol ID
- 5R01CA098685-02
- Other IDs
- 1R01CA098685-01A2
- Acronym
- QWIThelper
- Status last verified
- Sep 2006
- First submitted
- 4 Apr 2006
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Committee on Substance Abuse. American Academy of Pediatrics: Tobacco's toll: implications for the pediatrician. Pediatrics. 2001 Apr;107(4):794-8.
PubMed 11335763Aveyard P, Cheng KK, Almond J, Sherratt E, Lancashire R, Lawrence T, Griffin C, Evans O. Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools. BMJ. 1999 Oct 9;319(7215):948-53. doi: 10.1136/bmj.319.7215.948.
PubMed 10514156Balch GI. Exploring perceptions of smoking cessation among high school smokers: input and feedback from focus groups. Prev Med. 1998 Sep-Oct;27(5 Pt 3):A55-63. doi: 10.1006/pmed.1998.0382.
PubMed 9808818Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
PubMed 847061Benuck I, Gidding SS, Binns HJ. Identification of adolescent tobacco users in a pediatric practice. Arch Pediatr Adolesc Med. 2001 Jan;155(1):32-5. doi: 10.1001/archpedi.155.1.32.
PubMed 11177059Bernard HR, Ryan GW. Text analysis: Qualitative and Quantitative Methods. In Handbook of Methods in Cultural Anthropology. Walnut Creek, CA: AltaMira Press; 1998
Botvin GJ, Baker E, Dusenbury L, Tortu S, Botvin EM. Preventing adolescent drug abuse through a multimodal cognitive-behavioral approach: results of a 3-year study. J Consult Clin Psychol. 1990 Aug;58(4):437-46. doi: 10.1037//0022-006x.58.4.437.
PubMed 2212181Bowen DJ, Kinne S, Orlandi M. School policy in COMMIT: a promising strategy to reduce smoking by youth. J Sch Health. 1995 Apr;65(4):140-4. doi: 10.1111/j.1746-1561.1995.tb06217.x.
PubMed 7603051Bracken AC, Hersh AL, Johnson DJ. A computerized school-based health assessment with rapid feedback to improve adolescent health. Clin Pediatr (Phila). 1998 Nov;37(11):677-83. doi: 10.1177/000992289803701106.
PubMed 9825212Breslau N, Peterson EL. Smoking cessation in young adults: age at initiation of cigarette smoking and other suspected influences. Am J Public Health. 1996 Feb;86(2):214-20. doi: 10.2105/ajph.86.2.214.
PubMed 8633738Burt RD, Peterson AV Jr. Smoking cessation among high school seniors. Prev Med. 1998 May-Jun;27(3):319-27. doi: 10.1006/pmed.1998.0269.
PubMed 9612822Burton D. Tobacco cessation programs for adolescents. In: Richmond R, editor. Interventions for Smokers, an International Perspective. Baltimore, MD: Williams & Wilkins; 1994. p. 95-105.
Cannell M. Generation Online: Internet use of teenagers. Science World 1999;55(9):5
Chassin L, Presson CC, Rose JS, Sherman SJ. The natural history of cigarette smoking from adolescence to adulthood: demographic predictors of continuity and change. Health Psychol. 1996 Nov;15(6):478-84. doi: 10.1037//0278-6133.15.6.478.
PubMed 8973929Chen PH, White HR, Pandina RJ. Predictors of smoking cessation from adolescence into young adulthood. Addict Behav. 2001 Jul-Aug;26(4):517-29. doi: 10.1016/s0306-4603(00)00142-8.
PubMed 11456075
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone and Web-based Teen Tobacco Cessation in HMOs
- ClinicalTrials.gov ID
- NCT00311948
- Acronym / sponsor ID
- QWIThelper / 5R01CA098685-02
- Conditions
- Tobacco Use
- Keywords
- Teen smokers, Quithelper, Tobacco, Tobacco Website, Website Intervention, Tobacco counseling, Tobacco abstinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 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.
The purpose of this study is to look at both the clinicians' ability to reach out to the teen smokers and to evaluate the efficacy of providing tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment.
Detailed description
Health maintenance organizations have the mission, incentive, communication tools, and credibility with patients to reach out to teen members who use tobacco. The overall aim of this project is to refine and test both the potential reach and the efficacy of tobacco cessation support using a proactive telephone quitline combined with an interactive Web-based program for teens within a managed care environment. As part of a clinician-directed outreach effort, we will work closely with pediatric clinicians to maximize the program's reach into the teen smoker population as identified through the electronic data base of a large HMO. We will use letters and proactive outreach calls to assess current smoking status and recruit 600 15- to 18-year-old teen smokers who are interested in quitting and would be willing to receive cessation support via telephone and the Web. A second aim will be to randomly assign interested teen smokers to receive a proactive telephone- and Web-based tobacco cessation program or access to a website with cessation materials (control condition) to test the efficacy of the program on long-term cessation rates at 6- and 12-months. We will use several process measures to assess our ability to implement and consistently deliver both the telephone and Web components of the intervention. We will measure mediating variables to determine they support the hypothesized linkages between the theoretical constructs described by our cognitive behavioral model of action. An effective managed care partnership with clinicians to assess, recruit, and intervene with teen smokers would be of great interest to clinicians and health plan managers, highly exportable, and would be given high priority for implementation at the population level.
Our specific aims are as follows:
- Compare the population-based recruitment yields and costs of three proactive outreach approaches: 1) outreach calls only to those teen smokers who are seen, advised, and referred to us by their clinician; 2) outreach calls to a random sample of teens shown as being smokers in the EMR; and 3) outreach calls to a sample of all teens
- Assess efficacy/effectiveness in a randomized trial with 600 teen smokers to evaluate the hypothesis that proactive telephone-based counseling integrated with an interactive website will increase 6- and 12-month abstinence rates (30-day point prevalence) relative to a control condition receiving mailed cessation materials alone
- Assess the hypothesis that the telephone and web-based intervention will improve longer-term maintenance of abstinence at an 12-month follow-up point compared to the control condition
- Describe use patterns for key intervention process measures (e.g., calls completed, use of website) and determine if intervention affects outcome through theoretical mediators (e.g., pros/cons, stage, efficacy)
- Determine the total costs of the telephone and web-based program from the perspective of the HMO and replication costs in other settings, and report costs as incremental costs per member per month, per program participant, and per quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone counseling + interactive website | Active comparator | Behavioral: Telephone counseling + interactive website = more abstinenceTeen has access to interactive website and receives tailored telephone counseling |
| Control with interactive website | Other | Behavioral: Behavioral: interactive websiteTeen only has access to interactive website. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 15-18 years old
- both males and females
- smoking cigarettes at least four days a month
- some interest in quitting (will take all teen regardless of stage of readiness
- no evidence of treatment for depression, alcohol, or drugs in last year
Key exclusion criteria (4 listed)
- <15 years old
- >18 years old
- treated within 1 year for depression, alcohol, or drugs
- No internet access or phone access
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 |
|---|---|---|
| Telephone counseling + interactive website = more abstinence | Behavioural | Telephone counseling + interactive website |
| Behavioral: interactive website | Behavioural | Control with interactive website |
Primary outcome
Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up.
Time frame: 6 months and 12 months
self report of smoking in last 30 days
12-month measure to determine long-term assessment
Time frame: 12-months
Self report smoking or not smoking.
7 secondary outcomes
A six-month assessment to determine short-term effects
Time frame: 6 months
Assess the prevalence of smoking on 25 or more days per month
Time frame: 1 month
Assess sustained abstinence (e.g., three and six months) at each follow-up,
Time frame: 3 months and 6 months
Assess change in stage of change
Time frame: 6 months and 12 months
Assess amount smoked, and use of other tobacco products (including smokeless tobacco) in the last week, 30 days, three months, and six months prior to the follow-up assessment.
Time frame: 30 days, 6 months, 12 months
Measure the proportion of teen smokers who are recruited through direct physician referral versus proactive outreach
Time frame: 1 day
Compare the population-based recruitment yields and costs of three proactive outreach approaches that health plans might implement
Time frame: 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 28 Sep 2012.
- Background: PubMed 11335763Committee on Substance Abuse. American Academy of Pediatrics: Tobacco's toll: implications for the pediatrician. Pediatrics. 2001 Apr;107(4):794-8.
- Background: PubMed 10514156Aveyard P, Cheng KK, Almond J, Sherratt E, Lancashire R, Lawrence T, Griffin C, Evans O. Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools. BMJ. 1999 Oct 9;319(7215):948-53. doi: 10.1136/bmj.319.7215.948.
- Background: PubMed 9808818Balch GI. Exploring perceptions of smoking cessation among high school smokers: input and feedback from focus groups. Prev Med. 1998 Sep-Oct;27(5 Pt 3):A55-63. doi: 10.1006/pmed.1998.0382.
- Background: PubMed 847061Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Background: PubMed 11177059Benuck I, Gidding SS, Binns HJ. Identification of adolescent tobacco users in a pediatric practice. Arch Pediatr Adolesc Med. 2001 Jan;155(1):32-5. doi: 10.1001/archpedi.155.1.32.
- BackgroundBernard HR, Ryan GW. Text analysis: Qualitative and Quantitative Methods. In Handbook of Methods in Cultural Anthropology. Walnut Creek, CA: AltaMira Press; 1998
- Background: PubMed 2212181Botvin GJ, Baker E, Dusenbury L, Tortu S, Botvin EM. Preventing adolescent drug abuse through a multimodal cognitive-behavioral approach: results of a 3-year study. J Consult Clin Psychol. 1990 Aug;58(4):437-46. doi: 10.1037//0022-006x.58.4.437.
- Background: PubMed 7603051Bowen DJ, Kinne S, Orlandi M. School policy in COMMIT: a promising strategy to reduce smoking by youth. J Sch Health. 1995 Apr;65(4):140-4. doi: 10.1111/j.1746-1561.1995.tb06217.x.
- Background: PubMed 9825212Bracken AC, Hersh AL, Johnson DJ. A computerized school-based health assessment with rapid feedback to improve adolescent health. Clin Pediatr (Phila). 1998 Nov;37(11):677-83. doi: 10.1177/000992289803701106.
- Background: PubMed 8633738Breslau N, Peterson EL. Smoking cessation in young adults: age at initiation of cigarette smoking and other suspected influences. Am J Public Health. 1996 Feb;86(2):214-20. doi: 10.2105/ajph.86.2.214.
- Background: PubMed 9612822Burt RD, Peterson AV Jr. Smoking cessation among high school seniors. Prev Med. 1998 May-Jun;27(3):319-27. doi: 10.1006/pmed.1998.0269.
- BackgroundBurton D. Tobacco cessation programs for adolescents. In: Richmond R, editor. Interventions for Smokers, an International Perspective. Baltimore, MD: Williams & Wilkins; 1994. p. 95-105.
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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.
Jack F Hollis, Ph.D. principal investigator
Kaiser Permanente
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone counseling + interactive website = more abstinence and Behavioral: interactive website in people with Tobacco Use, run by Kaiser Permanente at 3 sites 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 9 inclusion and 4 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 28 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Participants' self-report of smoking one or more cigarettes in the past month at the 6-month and 12-month follow-up. (time frame: 6 months and 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 NCT00311948, which also lists 100 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 28 Sep 2012.