Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy of Tobacco Quitline for Childhood Cancer Survivors
This study is currently recruiting participants.
Verified by St. Jude Children's Research Hospital, June 2009
First Received: January 21, 2009   Last Updated: June 17, 2009   History of Changes
Sponsors and Collaborators: St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Information provided by: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00827866
  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, adult survivors of childhood cancer. Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) will serve as the method of recruitment. Participants (n=950) 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 provision of free 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.


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

Study Type: Interventional
Study Design: Open Label, Parallel Assignment
Official Title: Efficacy of Tobacco Quitline for Childhood Cancer Survivors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: October 2008
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Counselor-Initiated Tobacco Quit Line Group
Other: Counselor-Initiated Tobacco Quit Line
Counselor-Initiated Tobacco Quit Line
2
Self-Paced Tobacco Quit Line Group
Other: Self-Paced Tobacco Quit Line
Self-Paced Tobacco Quit Line

  Eligibility

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

Inclusion Criteria:

  • Participants will be approximately 950 adult survivors who are long-term childhood cancer survivors.
  • They have to have been smoking for at least one yea.
  • The primary inclusionary criterion is that they are a childhood cancer survivor defined as diagnosis of cancer before the age of 21.
  • Participants must be at least 18 years of age, and must be at least one year out of active cancer treatment.
  • Any histologic subtype of childhood cancer will qualify for entry into this study.
  • Participants must speak English and have access to a telephone for participation.

Exclusion Criteria:

  • Inability to understand consent procedures
  • Current substance abuse or alcohol use of ≥ 21 drinks/week
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827866

Contacts
Contact: Robert C Klesges, PhD 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Robert C Klesges, PhD            
Principal Investigator: Robert C Klesges, PhD            
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 ( Robert C. Klesges, PhD )
Study ID Numbers: XPD07-140
Study First Received: January 21, 2009
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00827866     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Smoking

ClinicalTrials.gov processed this record on September 11, 2009