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OpenTrials
Completed

NCT Number: NCT00827866

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).

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counselor-Initiated Tobacco Quit Line

Other

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

Self-Paced Tobacco Quit Line

Other

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

Primary outcomes

  1. Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up

    Time frame: 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2009
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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