Efficacy of Tobacco Quitline for Cancer Survivors

Smoking Cessation Clinical Trial

Official title:

Efficacy of Tobacco Quitline for Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827866
• Other study ID #: XPD07-140 Quit-Line
• Secondary ID: R01CA127964
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: November 24, 2014
• Start date: October 2008
• Est. completion date: November 2013

Study information

• Verified date: November 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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) 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Counselor-Initiated Tobacco Quit Line
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 Line
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up		1 year	No
Secondary	Account for dose of treatment (NRT use plus number of QL contact) vs. success(quit for one year response) independent of treatment assignment		1 year	No

External Links

•   St. Jude Children's Research Hospital