Efficacy of Tobacco Quitline for Cancer Survivors

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).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Counselor-Initiated Tobacco Quit Line; Other: Self-Paced Tobacco Quit Line

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 Type: Interventional
• Enrollment (Actual): 946
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Counselor-Initiated Tobacco Quit Line Group QL where the counselor contacts the client with a standardized intervention protocol)	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.; Other Names: Other: Arm 1
Other: 2; Self-Paced Tobacco Quit Line Group which leaves the calling up to participants	Other: 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.; Other Names: Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert C Klesges, PhD, St. Jude Children's Research Hospital

Publications and helpful links

General 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.

Helpful Links

• St. Jude Children's Research Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Childhood cancer survivors; Tobacco quitline; Adult-onset cancer survivors
• Other Study ID Numbers: XPD07-140 Quit-Line; R01CA127964 (U.S. NIH Grant/Contract)