Clinical Trials (PDQ®)
|No phase specified||Educational/Counseling/Training||Closed||18 and over||NCI||CCCWFU 99211|
U10CA081851, 99211, WFU-99211, NCT01434342
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.
- To obtain a preliminary estimate of the quit rate (as defined by 7-day point-prevalence abstinence) in intervention and control groups. To accomplish this aim, following the intervention we will collect confirmed smoking status data for intervention and control subjects. We will also obtain a preliminary estimate of the treatment effect (difference in quit rates between the two groups) and the standard deviation to better determine the sample size for a future trial.
- To evaluate primary patient reported outcomes, including quality of life (quantified by the FACT-G and for lung cancer patients only the FACT-L other concerns questions and the EORTC QLQ LC13), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the CESD-10), in cancer patients in the intervention and control groups.
- To refine the recruitment and intervention protocols using data collected from participants, Clinical Research Associate (CRA) Counselor, and Quitline staff to increase acceptability and improve retention in future trials.
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.
- Arm I (intervention): Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. During the counseling session, participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues such as managing the stressors associated with cancer diagnosis and treatment. They are also told to expect a call from the Quitline in 2-3 days and receive a fact sheet about benefits of smoking cessation for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Calls are scheduled at convenient times for the participants and at relapse-sensitive intervals including; an initial planning and assessment call, a quit date call, a follow-up call 7 days after the participant's quit date, and 2 additional calls at 2-3-week intervals. Participants are also encouraged to utilize the Quit for Life Web Coach, an interactive web program application that guides them to build online quit plans, set quit dates, and track their progress toward quitting. Participants also learn behavioral tips and coping skills by interacting with others in topic-based discussion forums and community support programs.
- Arm II (standard of care): Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute's "Clearing the Air" smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
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 Lead Organizations/Sponsors
Wake Forest NCORP Research BaseNational Cancer Institute
|Kathryn Weaver||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01434342
ClinicalTrials.gov processed this data on January 12, 2015
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