Smoking CessationNCT00827866
Efficacy of Tobacco Quitline for Cancer Survivors
A study testing Counselor-Initiated Tobacco Quit Line and Self-Paced Tobacco Quit Line in people with Smoking Cessation, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Counselor-Initiated Tobacco Quit Line and Self-Paced Tobacco Quit Line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 946 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants smokes cigarettes
- Participants is a cancer survivor
- Participant must be at least 18 years of age.
- Childhood cancer survivors must be at least one year out active cancer treatment.
- Participant understands consent procedures.
- Participant speaks English.
- Participant must have access to a telephone for participation
Who cannot join
- Inability to understand consent procedures
- Participants with a known contraindication or sensitivity to nicotine replacement therapy may participate in this study; however they will not receive nicotine replacement therapy (NRT) as part of their smoking cessation program.
- Since our participants are childhood cancer survivors and they can be medically fragile and we are interested in providing all eligible participants with NRT to enhance their ability to quit smoking, we added a cautionary conditions list to the recruitment screening form. Those with severe arrhythmias, myocardial infarction, unstable angina, cerebrovascular incident, blood vessel disease, phaeochromocytoma, diabetes, hyperthyroidism, abnormal kidney or liver function, or history of gastritis or peptic ulcers, or who smoke less than 5 cigarettes per day will not receive NRT.
- Patients with questionable NRT eligibility will be discussed/reviewed on a case by case basis with the Staff Family Physician
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the primary methods of recruitment.
The specific aims of the study :
(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term (one year) efficacy of the intervention condition for participants randomly assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).
Read the detailed description
In this study participants (n=1242) will be randomly assigned to a Counselor-Initiated Tobacco Quit Line (QL;) in which the counselor contacts the client with the standardized intervention protocol, or a Self-Paced Tobacco QL (which leaves the calling up to participants).The proposed active intervention will be a the Counselor-Initiated QL which includes 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention. The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition.
- Conditions
- Smoking Cessation
- Being tested
- Counselor-Initiated Tobacco Quit Line, Self-Paced Tobacco Quit Line
- Keywords
- Tobacco quitline, Childhood cancer survivors, Adult-onset cancer survivors
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselor-Initiated Tobacco Quit LineOther
Also called Other: Arm 1
The proposed active intervention will be a the Counselor-Initiated QL which includes provision of 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention.
Self-Paced Tobacco Quit LineOther
Also called Arm 2
The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Counselor-Initiated Tobacco Quit Line Group QL where the counselor contacts the client with a standardized intervention protocol) Receives: Other: Counselor-Initiated Tobacco Quit Line |
| 2 | Other | Self-Paced Tobacco Quit Line Group which leaves the calling up to participants Receives: Other: Self-Paced Tobacco Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up
Measured: 1 year
Secondary outcomes (1)
Account for dose of treatment (NRT use plus number of QL contact) vs. success(quit for one year response) independent of treatment assignment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert C Klesges, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827866
- Sponsor's protocol ID
- XPD07-140 Quit-Line
- Other IDs
- R01CA127964
- Status last verified
- Nov 2014
- First submitted
- 21 Jan 2009
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Klesges RC, Krukowski RA, Klosky JL, Liu W, Srivastava DK, Boyett JM, Lanctot JQ, Hudson MM, Folsom C, Lando H, Robison LL. Efficacy of a tobacco quitline among adult cancer survivors. Prev Med. 2015 Apr;73:22-7. doi: 10.1016/j.ypmed.2014.12.019. Epub 2015 Jan 5.
PubMed 25572620
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tobacco Quitline for Cancer Survivors
- ClinicalTrials.gov ID
- NCT00827866
- Acronym / sponsor ID
- XPD07-140 Quit-Line
- Conditions
- Smoking Cessation
- Keywords
- Tobacco quitline, Childhood cancer survivors, Adult-onset cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jan 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.
The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year) efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the primary methods of recruitment.
The specific aims of the study :
(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term (one year) efficacy of the intervention condition for participants randomly assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).
Detailed description
In this study participants (n=1242) will be randomly assigned to a Counselor-Initiated Tobacco Quit Line (QL;) in which the counselor contacts the client with the standardized intervention protocol, or a Self-Paced Tobacco QL (which leaves the calling up to participants).The proposed active intervention will be a the Counselor-Initiated QL which includes 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention. The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Counselor-Initiated Tobacco Quit LineCounselor-Initiated Tobacco Quit Line Group QL where the counselor contacts the client with a standardized intervention protocol) |
| 2 | Other | Other: Self-Paced Tobacco Quit LineSelf-Paced Tobacco Quit Line Group which leaves the calling up to participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants smokes cigarettes
- Participants is a cancer survivor
- Participant must be at least 18 years of age.
- Childhood cancer survivors must be at least one year out active cancer treatment.
- Participant understands consent procedures.
Key exclusion criteria (4 listed)
- Inability to understand consent procedures
- Participants with a known contraindication or sensitivity to nicotine replacement therapy may participate in this study; however they will not receive nicotine replacement therapy (NRT) as part of their smoking cessation program.
- Since our participants are childhood cancer survivors and they can be medically fragile and we are interested in providing all eligible participants with NRT to enhance their ability to quit smoking, we added a cautionary conditions list to the recruitment screening form. Those with severe arrhythmias, myocardial infarction, unstable angina, cerebrovascular incident, blood vessel disease, phaeochromocytoma, diabetes, hyperthyroidism, abnormal kidney or liver function, or history of gastritis or peptic ulcers, or who smoke less than 5 cigarettes per day will not receive NRT.
- Patients with questionable NRT eligibility will be discussed/reviewed on a case by case basis with the Staff Family Physician
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 |
|---|---|---|
| Counselor-Initiated Tobacco Quit LineAlso: Other: Arm 1The proposed active intervention will be a the Counselor-Initiated QL which includes provision of 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention. | Other | 1 |
| Self-Paced Tobacco Quit LineAlso: Arm 2The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition. | Other | 2 |
Primary outcome
Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up
Time frame: 1 year
1 secondary outcome
Account for dose of treatment (NRT use plus number of QL contact) vs. success(quit for one year response) independent of treatment assignment
Time frame: 1 year
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 25 Nov 2014.
- Derived from this study: PubMed 25572620Klesges RC, Krukowski RA, Klosky JL, Liu W, Srivastava DK, Boyett JM, Lanctot JQ, Hudson MM, Folsom C, Lando H, Robison LL. Efficacy of a tobacco quitline among adult cancer survivors. Prev Med. 2015 Apr;73:22-7. doi: 10.1016/j.ypmed.2014.12.019. Epub 2015 Jan 5.
- St. Jude Children's Research HospitalLink 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.
Robert C Klesges, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselor-Initiated Tobacco Quit Line and Self-Paced Tobacco Quit Line in people with Smoking Cessation, run by St. Jude Children's Research Hospital 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 7 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 25 Nov 2014. 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?
Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (time frame: 1 year). 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 NCT00827866, which also lists 1 linked publication.
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 25 Nov 2014.