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Efficacy of Tobacco Quitline for Cancer Survivors


N/A
18 Years
N/A
Open (Enrolling)
Both
Smoking Cessation

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Trial Information

Efficacy of Tobacco Quitline for Cancer Survivors


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Robert C Klesges, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

XPD07-140 Quit-Line

NCT ID:

NCT00827866

Start Date:

October 2008

Completion Date:

November 2013

Related Keywords:

  • Smoking Cessation
  • Tobacco quitline
  • Childhood cancer survivors
  • Adult-onset cancer survivors
  • Smoking

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794