A Feasibility Study of Smoking Cessation Program in Radiation Oncology
18 Years
N/A
Both
Cancer and Tobacco Abuse
Trial Information
A Feasibility Study of Smoking Cessation Program in Radiation Oncology
There is overwhelming evidence to support tobacco use as the number one cause of preventable
cancer and cardiovascular death. Smoking is responsible for at least 30% of all cancer
deaths and nearly 90% of lung cancer deaths. There is robust phase III randomized data to
show improved smoking cessation with both behavioral strategies as well as pharmacologic
interventions such as bupropion.
Despite significant evidence showing survival, toxicity and quality of life detriments in
cancer patients who continue smoking after diagnosis, roughly one third of cancer patients
continue to use tobacco. There is a relative paucity of data regarding smoking cessation
programs in cancer patient populations. Several single institution, as well as cooperative
group (ECOG), efforts have been published with varying results. However, to date, there are
no published reports on the success of pharmacologic smoking cessation interventions in
cancer patients.
Patients undergoing definitive/curative radiotherapy often receive daily treatment over the
course of three to eight weeks. They are often accompanied and supported daily by family
members or companions, many of whom smoke. This represents a huge exposure to the health
care system and a unique opportunity for intensive intervention in both cancer patients and
their families/companions during their "daily routine" of radiotherapy. To date, there is no
published report on intensive tobacco cessation intervention concurrent with radiotherapy in
cancer patients and their families or companions.
We propose a feasibility study of an intensive tobacco cessation program to be delivered to
radiation oncology patients and/or their family/companions concurrent with planned
radiotherapy. This program will feature an intensive behavioral intervention as well as
the pharmacologic agent bupropion.
Inclusion Criteria:
- Eligibility for Radiotherapy Patients
- age 18 years or older
- receiving three weeks or more of external beam radiotherapy
- report smoking one or more cigarettes in the past 30 days or self-identify as a
smoker
- Cancer Stage:
- Stage I-III
- IVa Head and Neck Malignancy is allowed
- Stage I-IV breast, prostate, testis or lymphoma also allowed
- at least one year life expectancy
- have given written informed consent
- KPS 70-100
Eligibility for Family/Companions of Radiotherapy Patients (Note: Family
members/companions are eligible for this protocol regardless of whether the index
radiotherapy patient is eligible or willing to participate.)
- age 18 years or older
- at least one year life expectancy
- radiotherapy patient is receiving three weeks or more of external beam radiotherapy
- Person is committed to bringing/accompanying the patient to radiotherapy at least
three days per week.
- report smoking one or more cigarettes in the past 30 days or self-identify as a
smoker
- Family member/companion of patients under radiotherapy treatment for any stage of
cancer
- have given written informed consent
- KPS 70-100
Exclusion Criteria:
- Exclusion Criteria for both Radiotherapy Patients and their Families/Companions
- serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic
disorders, as assessed by the study-site physician
- a current diagnosis of major depressive episode or a history of panic disorder,
psychosis, bipolar disorder, or eating disorders
- pregnancy or lactation
- any history of allergy/intolerance or adverse reaction to bupropion
- history of seizure disorder, bulimia or anorexia nervosa
- use of an MAOi within 14 days
- current use of another antidepressant
- abrupt discontinuation of alcohol or sedatives
- unwilling/unable to meet with the behavioral interventionalist for 20 minutes, at
least 3 days per week during the course of radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic.
Outcome Time Frame:
1 year from enrollment
Principal Investigator
Anna McDaniel, DNS, RN, FAAN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Environments for Health, Indiana University School of Nursing
Authority:
United States: Food and Drug Administration
Study ID:
0508-12
NCT ID:
NCT00236288
Start Date:
October 2005
Completion Date:
April 2007
Related Keywords:
- Cancer and Tobacco Abuse
- Cancer treatment and tobacco abuse
- Tobacco Use Disorder
Name | Location |
|---|---|
| Indiana University, Department of Radiation Oncology | Indianapolis, Indiana 46202 |
