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Co mp r eh en siv e Ca n c er Cen te r o f Wa ke Fo r es t C CO P Re sea r ch Ba se
Feasibility of Delivering Quitline Based Smoking Cessation Intervention
in the Outpatient Oncology Setting: A Pilot Study
Informed Consent Form to Participate in Research
Kathryn E. Weaver, Ph.D., M.P.H, Principal Investigator
INTRODUCTION
You are invited to be in a research study on how smoking cessation programs can help people
with lung cancer to quit smoking. Research studies are designed to gain scientific knowledge
that may help other people in the future. You may or may not receive any benefit from being
part of the study. There may also be risks associated with being part of research studies. You
are being asked to take part in this study because you have lung cancer and have smoked any
amount within the past 7 days. Your participation is voluntary. Please take your time to make
your decision. You may ask your study doctor or the study staff to explain any words or
information that you do not understand. You may also discuss the study with your friends and
family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to understand how programs to help smokers quit may
impact people with lung cancer who are interested in quitting smoking. We want to learn about
the effects of receiving smoking cessation programs on you and your health. We will also
assess the ease of delivering a Quitline based smoking cessation intervention to lung cancer
patients in an outpatient setting.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Approximately 146 people at possibly 40 research sites will take part in this study.
WHAT IS INVOLVED IN THE STUDY?
You will be randomly assigned (like the flip of a coin) to one of two groups:
1) The Usual Care Group will receive an educational booklet about quitting smoking and
the opportunity to get telephone counseling through the Quitline Program after the study
ends. If you are randomized to this group, you will receive the usual care and treatment
from your doctor. This may or may not include nicotine replacement therapy.
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Or
2) Quitline Intervention Group (counseling + nicotine replacement patch) will receive
quitting help from a nurse or other health professional and telephone counseling, as well
as the opportunity to get free nicotine replacement patches (also known as “The Patch”).
Participants on both arms
 Will be assessed by their physician or intervention nurses for appropriateness for
nicotine replacement patches.
 Will receive a letter with advice regarding smoking cessation from their doctor.
 Will receive a phone call by the research nurse at 3 and 6 weeks for general follow up.
Participation in either group will involve filling out questionnaires at the beginning of the study
and again 6, 12, and 24 weeks later. Each study questionnaire contains basic information about
you, your health, emotional functioning, and quality of life. Each packet of questionnaires will
take approximately 15 -30 minutes to complete. Participants in the Quitline Intervention group
will also be asked to complete the Nicotine Replacement Diary and return at 6 and 12 weeks
after the start of the intervention.
At 12 and 24 week clinic appointments, you may be asked to provide a urine sample to measure
the amount of cotinine in your body. This is a measure of exposure to tobacco products during
the past several days.
If randomized into the Quitline Intervention group, you will be asked to spend 15-30 minutes
talking with a nurse or other health professional about quitting smoking. That appointment
should take place within two weeks from study registration.
In addition, you will be telephoned by Alere Wellbeing, Inc, the Quit for Life Program staff, over
a 12 week period. Each call is designed to provide expert support to help participants develop
problem-solving and coping skills, secure social support, and design a short term and long term
plan to help smokers successfully stop smoking.
Calls are scheduled at times convenient 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
 two additional calls at 2-3 week intervals.
Quitline will also ask you a series of medical questions to learn about any health problems that
would require additional physician consent if any conditions that are contrary to nicotine
replacement therapy are present.
A Quitline contractor will mail an 8 week supply of Habitrol nicotine replacement patches to
participants randomized to the Quitline Intervention Group who have been cleared by their
physician for nicotine replacement and agree to receive nicotine replacement.
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The patch is placed directly on the skin. Instructions for using the patch will be reviewed with
you during the coaching call and will be included with the nicotine patch shipment.
A research staff member will collect information from your medical record on your cancer
diagnosis and treatment and history of other medical conditions. Only study staff will see this
information.
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for a total of 6-7 months. You can stop participating at any time. If you
decide to stop participating in the study, we encourage you to talk to the investigators or study
staff first.
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves very little risk to you. You should discuss the risk of being in this
study with the study staff. Risks and side effects related to the nicotine replacement therapy are
listed as follows:
Most common side effects:
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Rash
Itching
Localized Burning sensation
Trouble Sleeping
Vivid dreams
Upset Stomach
Headache
Less Common side effects include:
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Anxiety
Constipation
Depression
Diarrhea
Dry Mouth
Muscle Pain
Nausea
Nervousness
Serious but Less Common side effects include:
 Shortness of Breath
 Chest pain
 Swelling of the throat
There also may be other side effects that we cannot predict. You should tell your doctor and the
research study staff about all the medications, vitamins and supplements you take and any
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medical conditions you have. This may help avoid side effects, interactions with other drugs and
other unknown or unpredictable risks.
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.
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.
Breastfeeding mothers are excluded from this study. There is an unknown potential risk of
adverse events in nursing infants secondary to treatment of the mother with nicotine
replacement patches.
A Data Safety and Monitoring Committee, an independent group of experts in research, will be
reviewing the results, toxicities and side effects of this research throughout the study.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may be direct benefit to you. You will have the
opportunity to participate in a program to help you quit smoking that may produce direct
(physical and/or psychological) benefits for you. We hope the information learned from this
study will benefit other people in the future. By taking part in this study, you will help increase
scientific knowledge about how smoking cessation programs may help people with lung cancer
quit smoking.
WHAT OTHER CHOICES ARE THERE?
You may choose to participate in another smoking cessation study, or a different type of study.
You may choose not to participate in this study.
WHAT ABOUT MY HEALTH INFORMATION?
(This section is HIPAA related and may be omitted or replaced or revised per site
discretion. This section must include a statement that FDA, NCI, CCCWFU, Drug Co
may inspect records and a specific statement that clinical trial information will be
entered into a databank.)
In this research study, any new information we collect from you about your health or behaviors
is considered Protected Health Information. The information we will collect for this research
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study includes: Information about you which is collected or created during the study for research
purposes.
If this research study involves the diagnosis of treatment of a medical condition, then Protected
Health Information collected from you during this study will be placed in your medical record,
and may be used to help treat you, arrange payment for your care, or assist with Medical Center
operations.
We will make every effort to keep your Protected Health Information private. We will store
records of your Protected Health Information in a cabinet in a locked office or on a password
protected computer. Only the following people or organizations will be granted access to your
Protected Health Information:
1) The study investigator and his/her staff, or others at Wake Forest University Health
Sciences who oversee research.
2) Other people or laboratories providing services for this research project on behalf of
Wake Forest University Health Sciences and Wake Forest University Baptist Medical
Center.
3) Quitline (Alere, Inc); the Institutional Review Board; representatives from government
agencies such as the Food and Drug Administration (FDA), the Department of Health
and Human Services (DHHS), National Cancer Institute (NCI) and similar agencies in
other countries.
If required by law or court order, we might also have to share your Protected Health Information
with a judge, law enforcement officer, government agencies, or others. If your Protected Health
Information is shared with any of these groups it might no longer be protected by federal or state
privacy rules.
Any Protected Health Information collected from you in this study will be kept in the research
records. This authorization does not expire. Any research information entered into your
medical record will be kept for as long as your medical record is kept by the Medical Center.
You will not be able to obtain a copy of your Protected Health Information in the research
records until all activities in the study are completely finished.
You can tell Include your site PI that you want to take away your permission to use and
share your Protected Health Information at any time by sending a letter to this address:
Include your site PI information here:
However, if you take away permission to use your Protected Health Information you will not be
able to be in the study any longer. We will stop collecting any more information about you, but
any information we have already collected can still be used for the purposes of the research
study. By signing this form you give us permission to use your Protected Health Information for
this study.
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Information about this clinical trial will be placed in the clinical trial registry maintained by the
National Institutes of Health/National Library of Medicine (NIH/NLM). A description of this clinical
trial will be available on www.ClinicalTrials.gov. This Web site will not include information that
can identify you. At most, the Web site will include a summary of the results. You can search
this Web site at any time.
Laboratory test results and other medical reports created as a result of your participation in the
research study may be entered into the computer systems of Wake Forest University Health
Sciences and North Carolina Baptist Hospital. These will be kept secure, with access to this
information limited to individuals with proper authority, but who may not be directly involved with
this research study.
WHAT ARE THE COSTS?
There are no costs to you for taking part in this study. All costs for tests and/or visits related to
this study will be paid for by the study.
Costs for your regular medical care, which are not related to this study, will be your own
responsibility. If you are in the group that receives nicotine replacement patches, the study will
provide these for free and there will be no cost to you.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no compensation for participating in this study.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by the Comprehensive Cancer Center of Wake Forest CCOP
Research Base. The researchers do not hold a direct financial interest in the sponsor or the
product being studied.
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A
RESULT OF PARTICIPATING IN THIS STUDY?
[Enter information per institution policies.]
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the
study at any time. Refusing to participate or leaving the study will not result in any penalty or
loss of benefits to which you are entitled. If you decide to stop participating in the study, we
encourage you to talk to the investigators or study staff first to learn about any potential health
or safety consequences. The investigators also have the right to stop your participation in the
study at any time. This could be because it is in your best medical interest.
You will be given any new information we become aware of that would affect your willingness to
continue to participate in the study.
Whom Do I Call if I Have Questions or Problems?
The Institutional Review Board (IRB) is a group of people who review the research to protect
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your rights. If you have a question about your rights as a research participant, or you would like
to discuss problems or concerns, have questions or want to offer input, or you want to obtain
additional information, you should contact the Chairman of the IRB at [Include your site IRB
information here.]
You will be given a copy of this signed consent form.
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SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as
described in this consent and authorization form. If I have not already received a copy of the
Privacy Notice, I may request one or one will be made available to me. I have had a chance to
ask questions about being in this study and have those questions answered. By signing this
consent and authorization form, I am not releasing or agreeing to release the investigator, the
sponsor, the institution or its agents from liability for negligence.
_____________________________________________________
Subject Name (Printed)
_____________________________________________________
Subject Signature
Date/Time
_____________________________________________________
Person Obtaining Consent
____________________
Date/Time
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