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Efficacy of Tobacco Quitline for Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00827866
First received: January 21, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Smoking Cessation
Other: Counselor-Initiated Tobacco Quit Line
Other: Self-Paced Tobacco Quit Line

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Efficacy of Tobacco Quitline for Cancer Survivors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 946
Study Start Date: October 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Other: Arm 1
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 Name: Arm 2

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827866

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Robert C Klesges, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00827866     History of Changes
Other Study ID Numbers: XPD07-140 Quit-Line, R01CA127964
Study First Received: January 21, 2009
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Tobacco quitline
Childhood cancer survivors
Adult-onset cancer survivors

ClinicalTrials.gov processed this record on November 20, 2014