Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients

OBJECTIVES:

Primary

* 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.

Secondary

- 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.

Inclusion Criteria:

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

Exclusion Criteria:

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.