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


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer, Tobacco Use Disorder, Breast Cancer, Colorectal Cancer, Prostate Cancer

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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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Evaluate a smoking cessation intervention among cancer patients

Outcome Description:

Evaluate a smoking cessation intervention among cancer patients who are scheduled to receive or currently receiving surgery, radiation or chemotherapy OR have received one or more of the following within the last 6 months surgery, last radiation treatment, or last chemotherapy treatment in a community outpatient setting.

Outcome Time Frame:

24 Weeks

Safety Issue:

No

Principal Investigator

Kathryn Weaver, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 99211

NCT ID:

NCT01434342

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Lung Cancer
  • Tobacco Use Disorder
  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • stage IA non-small cell lung cancer
  • stage IB non-small cell lung cancer
  • stage IIA non-small cell lung cancer
  • stage IIB non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • limited stage small cell lung cancer
  • tobacco use disorder
  • Breast Cancer
  • Cervical Cancer
  • head & neck cancer
  • Prostate Cancer
  • All histologies
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms
  • Tobacco Use Disorder

Name

Location

W F Baptist HealthWinston Salem, North Carolina  27157