Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
Sponsored by National Cancer Institute (NCI)
RATIONALE: Stop-smoking plans, including using a quitline (telephone) intervention, educational materials, and nicotine replacement therapy, may help patients with lung cancer quit smoking. It is not yet known whether a quitline, educational materials, and a nicotine patch is more effective than standard of care in helping adults quit smoking. PURPOSE: This randomized trial studies how well a quitline smoking intervention works compared to standard of care in helping patients with lung cancer who are receiving treatment.
AJCC Stages 0, I, II, & III lung, breast, prostate, colorectal, bladder, head & neck, and cervical cancers (all histologies)
Reports smoking any amount in the last 7 days
Scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following in the last 6 months surgery, last radiation treatment or last chemotherapy treatment
18 years of age or older
KPS of 70-100
Ability to understand and the willingness to sign a written informed consent document
Willing to consider quitting smoking
Unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or Myocardial Infarction in the past month
Current use or planned use of varenicline (Chantix), Zyban, Buproprion or any other nicotinic receptor agonist (Patients that discontinue use of these type drugs within 7 days are eligible.)
Current probable alcohol abuse as defined by more than 5 drinks per day for men and 4 drinks per day for women and a Alcohol Use Disorders Identification Test (AUDIT) score > 8. If patient answers "no" to 5 drinks per day for men and 4 drinks per day for women the patient is eligible. AUDIT assessment does not need to be administered. If patient answers "yes " to 5 drinks per day for men and 4 drinks per day for women the AUDIT assessment must be administered. If AUDIT score is > 8 patient is not eligible
Use of illegal drugs or use of prescription medications for non-medical reasons in the past month.
Current use of chewing, dipping and pipe tobacco, or cigars.
Patient does not have regular access to a telephone to receive Quitline calls lasting 15-30 minutes
History of allergic reactions attributed to compounds of similar chemical or biologic composition to nicotine replacement therapy.
Active Peptic Ulcer Disease
Uncontrolled intercurrent illness including, but not limited to, ongoing, psychiatric illness/social situations that would limit compliance with study requirements.
Due to unknown risks and potential harm to the unborn fetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. We encourage you to discuss this issue further with your doctors if you have any questions.
If you are pregnant, should become pregnant or suspect you are pregnant prior to or while participating in this study, you should inform your study physician immediately. Nicotine replacement therapy has the potential for teratogenic or abortifacient effects and is classified as a FDA Pregnancy category D drug. The U.S. Clinical Practice Guideline states that pregnant smokers should be encouraged to quit without medication based on insufficient evidence of effectiveness and hypothetical concerns with safety. Pregnant women enrolled in the study and randomized to the Quitline group intervention should participate in the Quitline intervention but not receive the nicotine replacement therapy.
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nicotine replacement therapy, breastfeeding women are excluded from the study.
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