Trial Information

Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Lung Cancer Patients Receiving Outpatient Treatment: A Pilot Study

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.