Unspecified Adult Solid Tumor, Protocol SpecificNCT00282009
Internet and Telephone Counseling for Smoking Cessation
A study testing Basic Internet, Enhanced Internet and Enhanced Internet + phone in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Georgetown University at 1 site in United States.
Trial summary
RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Basic Internet, Enhanced Internet and Enhanced Internet + phone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,205 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Dec 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Smokes at least 5 cigarettes a day
- No prior use of QuitNet website
- Must have access to the internet and a telephone at home or work
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention, as determined by 7-day point prevalence abstinence at 12 months, in adult smokers.
- Compare the cost-effectiveness of these interventions in promoting smoking cessation.
- Determine the effects of internet-based interventions on measured use of the intervention (frequency and duration of use, utilization of behavioral coping, expert advices, and e-mail) in these patients.
- Determine the effects of internet-based interventions on variables important for behavior change including mediators (e.g., self-efficacy, use of internet social support) and moderators (e.g., gender, baseline motivation) of outcomes in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to gender and baseline motivation level. Patients are randomized to 1 of 3 intervention arms.
- Arm I (basic internet program): Patients are directed to a website of existing QuitNet™ smoking cessation materials. These materials are not tailored and have no interactive features.
- Arm II (premium internet program): Patients receive free 6-month access to the QuitNet™ website including interactive and individualized intervention features.
- Arm III (premium internet program plus telephone counseling): Patients receive free access to the QuitNet™ website as in arm II. Patients also receive up to 5 telephone counseling sessions, scheduled at their convenience.
All patients are assessed at baseline and then at 3, 6, 12, and 18 months.
PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study.
- Being tested
- Basic Internet, Enhanced Internet, Enhanced Internet + phone
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic InternetBehavioural
Basic Internet control intervention
Enhanced InternetBehavioural
enhanced Internet cessation intervention
Enhanced Internet + phoneBehavioural
enhanced Internet plus proactive telephone counseling
| Study group | Role | What they receive |
|---|---|---|
| Basic Internet | Active comparator | Basic Internet Receives: Behavioral: Basic Internet |
| Enhanced Internet | Experimental | Enhanced Internet Receives: Behavioral: Enhanced Internet |
| Enhanced Internet plus Phone | Experimental | Enhanced Internet + proactive telephone counseling Receives: Behavioral: Enhanced Internet + phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment
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 posted25 Jan 2006 (estimated)
- Study startAug 2004
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Amanda L. Graham, PhD, Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282009
- Sponsor's protocol ID
- CDR0000465179
- Other IDs
- R01CA104836
- Status last verified
- Aug 2014
- First submitted
- 24 Jan 2006
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S43-8. doi: 10.1080/14622200601042521.
PubMed 17491170Graham AL, Papandonatos GD, Bock BC, Cobb NK, Baskin-Sommers A, Niaura R, Abrams DB. Internet- vs. telephone-administered questionnaires in a randomized trial of smoking cessation. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S49-57. doi: 10.1080/14622200601045367.
PubMed 17491171Graham AL, Papandonatos GD. Reliability of internet- versus telephone-administered questionnaires in a diverse sample of smokers. J Med Internet Res. 2008 Mar 26;10(1):e8. doi: 10.2196/jmir.987.
PubMed 18364345Graham AL, Cobb NK, Papandonatos GD, Moreno JL, Kang H, Tinkelman DG, Bock BC, Niaura RS, Abrams DB. A randomized trial of Internet and telephone treatment for smoking cessation. Arch Intern Med. 2011 Jan 10;171(1):46-53. doi: 10.1001/archinternmed.2010.451.
PubMed 21220660Graham AL, Papandonatos GD, Kang H, Moreno JL, Abrams DB. Development and validation of the online social support for smokers scale. J Med Internet Res. 2011 Sep 28;13(3):e69. doi: 10.2196/jmir.1801.
PubMed 21955465Graham AL, Chang Y, Fang Y, Cobb NK, Tinkelman DS, Niaura RS, Abrams DB, Mandelblatt JS. Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study. Tob Control. 2013 Nov;22(6):e11. doi: 10.1136/tobaccocontrol-2012-050465. Epub 2012 Sep 25.
PubMed 23010696Cobb CO, Niaura RS, Donaldson EA, Graham AL. Quit now? Quit soon? Quit when you're ready? Insights about target quit dates for smoking cessation from an online quit date tool. J Med Internet Res. 2014 Feb 17;16(2):e55. doi: 10.2196/jmir.3086.
PubMed 24534139Cobb CO, Graham AL. Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation. Nicotine Tob Res. 2014 Oct;16(10):1289-97. doi: 10.1093/ntr/ntu066. Epub 2014 May 8.
PubMed 24812022Graham AL, Papandonatos GD, Cobb CO, Cobb NK, Niaura RS, Abrams DB, Tinkelman DG. Internet and Telephone Treatment for smoking cessation: mediators and moderators of short-term abstinence. Nicotine Tob Res. 2015 Mar;17(3):299-308. doi: 10.1093/ntr/ntu144. Epub 2014 Aug 25.
PubMed 25156528Graham AL, Papandonatos GD, Erar B, Stanton CA. Use of an online smoking cessation community promotes abstinence: Results of propensity score weighting. Health Psychol. 2015 Dec;34S(0):1286-95. doi: 10.1037/hea0000278.
PubMed 26651470Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet and Telephone Counseling for Smoking Cessation
- ClinicalTrials.gov ID
- NCT00282009
- Acronym / sponsor ID
- CDR0000465179
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,205 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2004
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jan 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: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking.
Detailed description
OBJECTIVES:
- Compare the efficacy of premium internet intervention vs premium internet with telephone intervention vs basic internet intervention, as determined by 7-day point prevalence abstinence at 12 months, in adult smokers.
- Compare the cost-effectiveness of these interventions in promoting smoking cessation.
- Determine the effects of internet-based interventions on measured use of the intervention (frequency and duration of use, utilization of behavioral coping, expert advices, and e-mail) in these patients.
- Determine the effects of internet-based interventions on variables important for behavior change including mediators (e.g., self-efficacy, use of internet social support) and moderators (e.g., gender, baseline motivation) of outcomes in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to gender and baseline motivation level. Patients are randomized to 1 of 3 intervention arms.
- Arm I (basic internet program): Patients are directed to a website of existing QuitNet™ smoking cessation materials. These materials are not tailored and have no interactive features.
- Arm II (premium internet program): Patients receive free 6-month access to the QuitNet™ website including interactive and individualized intervention features.
- Arm III (premium internet program plus telephone counseling): Patients receive free access to the QuitNet™ website as in arm II. Patients also receive up to 5 telephone counseling sessions, scheduled at their convenience.
All patients are assessed at baseline and then at 3, 6, 12, and 18 months.
PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic Internet | Active comparator | Behavioral: Basic InternetBasic Internet |
| Enhanced Internet | Experimental | Behavioral: Enhanced InternetEnhanced Internet |
| Enhanced Internet plus Phone | Experimental | Behavioral: Enhanced Internet + phoneEnhanced Internet + proactive telephone counseling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Basic InternetBasic Internet control intervention | Behavioural | Basic Internet |
| Enhanced Internetenhanced Internet cessation intervention | Behavioural | Enhanced Internet |
| Enhanced Internet + phoneenhanced Internet plus proactive telephone counseling | Behavioural | Enhanced Internet plus Phone |
Primary outcome
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment
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 10 Feb 2016.
- Background: PubMed 17491170Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S43-8. doi: 10.1080/14622200601042521.
- Results publication: PubMed 17491171Graham AL, Papandonatos GD, Bock BC, Cobb NK, Baskin-Sommers A, Niaura R, Abrams DB. Internet- vs. telephone-administered questionnaires in a randomized trial of smoking cessation. Nicotine Tob Res. 2006 Dec;8 Suppl 1(Suppl 1):S49-57. doi: 10.1080/14622200601045367.
- Results publication: PubMed 18364345Graham AL, Papandonatos GD. Reliability of internet- versus telephone-administered questionnaires in a diverse sample of smokers. J Med Internet Res. 2008 Mar 26;10(1):e8. doi: 10.2196/jmir.987.
- Results publication: PubMed 21220660Graham AL, Cobb NK, Papandonatos GD, Moreno JL, Kang H, Tinkelman DG, Bock BC, Niaura RS, Abrams DB. A randomized trial of Internet and telephone treatment for smoking cessation. Arch Intern Med. 2011 Jan 10;171(1):46-53. doi: 10.1001/archinternmed.2010.451.
- Results publication: PubMed 21955465Graham AL, Papandonatos GD, Kang H, Moreno JL, Abrams DB. Development and validation of the online social support for smokers scale. J Med Internet Res. 2011 Sep 28;13(3):e69. doi: 10.2196/jmir.1801.
- Results publication: PubMed 23010696Graham AL, Chang Y, Fang Y, Cobb NK, Tinkelman DS, Niaura RS, Abrams DB, Mandelblatt JS. Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study. Tob Control. 2013 Nov;22(6):e11. doi: 10.1136/tobaccocontrol-2012-050465. Epub 2012 Sep 25.
- Results publication: PubMed 24534139Cobb CO, Niaura RS, Donaldson EA, Graham AL. Quit now? Quit soon? Quit when you're ready? Insights about target quit dates for smoking cessation from an online quit date tool. J Med Internet Res. 2014 Feb 17;16(2):e55. doi: 10.2196/jmir.3086.
- Results publication: PubMed 24812022Cobb CO, Graham AL. Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation. Nicotine Tob Res. 2014 Oct;16(10):1289-97. doi: 10.1093/ntr/ntu066. Epub 2014 May 8.
- Results publication: PubMed 25156528Graham AL, Papandonatos GD, Cobb CO, Cobb NK, Niaura RS, Abrams DB, Tinkelman DG. Internet and Telephone Treatment for smoking cessation: mediators and moderators of short-term abstinence. Nicotine Tob Res. 2015 Mar;17(3):299-308. doi: 10.1093/ntr/ntu144. Epub 2014 Aug 25.
- Results publication: PubMed 26651470Graham AL, Papandonatos GD, Erar B, Stanton CA. Use of an online smoking cessation community promotes abstinence: Results of propensity score weighting. Health Psychol. 2015 Dec;34S(0):1286-95. doi: 10.1037/hea0000278.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Individual participant dataSharing planned: No
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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.
Amanda L. Graham, PhD principal investigator
Lombardi Comprehensive 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 Basic Internet, Enhanced Internet and Enhanced Internet + phone in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Georgetown University 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?
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 10 Feb 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?
Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (time frame: 12 months). 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 NCT00282009, which also lists 11 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 10 Feb 2016.