Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
Basic Trial Information
RATIONALE: Continued smoking after a cancer diagnosis has important health consequences beyond the risks associated with smoking in the general population. Smoking reduces the efficacy of cancer treatments including surgery, radiation and chemotherapy. Despite the negative consequences, it is estimated that between 15-75% of patients with cancer continue to smoke after their cancer diagnosis. Lung, breast, prostate, colorectal, bladder, head & neck, and cervical cancer patients were chosen because there is evidence of potential clinical benefit associated with quitting smoking in all of these populations and they represent a mix of both smoking and non-smoking related cancers.
Further Study Information
* To assess the feasibility of delivering a Quitline based smoking cessation intervention to cancer patients in an outpatient setting. To achieve this, we will deliver the intervention to cancer patients in the surgery, radiation and medical oncology departments of participating Community Clinical Oncology Program (CCOP) sites. Following the intervention, we will assess participant, CRA (Clinical Research Associate) Counselor and Quitline staff ratings of acceptability, resources required to deliver the intervention, protocol fidelity, and participant recruitment, retention and adherence.
OUTLINE: This is a multicenter study. Participants are stratified according to time since diagnosis (< 3 months vs ≥ 3 months), treatment status (ongoing vs completed), and cigarette smoking (≤ 10 per day vs ≥ 11 per day). Patients are randomized to 1 of 2 intervention arms.
Participants on the intervention arm complete the Smoking Assessment, Smoking Cessation Self-Efficacy, the Brief Smoking Consequences, the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire LC-13, the Perceived Stress Scale, the Center for Epidemiologic Studies Short Depression Scale (CESD-10 Depression), and the Follow up Smoking Assessment questionnaires at baseline and at 6, 12, and 24 weeks.
Participants, on the intervention arm, undergo saliva sample collection at baseline and at 12 and 24 weeks for cotinine level analysis.
1. AJCC Stages 0, I, II, & III lung, breast, prostate, colorectal, bladder, head & neck, and cervical cancers (all histologies).
2. Reports smoking any amount in the last 7 days.
3. 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.
4. 18 years of age or older
5. KPS of 70-100
6. Ability to understand and the willingness to sign a written informed consent document.
7. Willing to consider quitting smoking
1. Unstable cardiac disease - defined as congestive heart failure, unstable angina, serious arrhythmias, or Myocardial Infarction in the past month.
2. 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.)
3. 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.
4. Use of illegal drugs or use of prescription medications for non-medical reasons in the past month.
5. Current use of chewing, dipping and pipe tobacco, or cigars.
6. Patient does not have regular access to a telephone to receive Quitline calls lasting 15-30 minutes.
7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to nicotine replacement therapy.
8. Active Peptic Ulcer Disease
9. Uncontrolled intercurrent illness including, but not limited to, ongoing, psychiatric illness/social situations that would limit compliance with study requirements.
10. 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.
11. 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.
12. 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.
Trial Contact Information
Trial Lead Organizations/Sponsors
Wake Forest NCORP Research Base
Kathryn Weaver, Principal Investigator
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.