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Sponsors and Collaborators: |
Indiana University School of Medicine Walther Cancer Institute |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00236288 |
To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions.
Condition | Intervention |
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Cancer and Tobacco Abuse |
Drug: Bupropion and intensive behavioral therapy |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Feasibility Study of Smoking Cessation Program in Radiation Oncology |
Estimated Enrollment: | 36 |
Study Start Date: | October 2005 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.)
Exclusion Criteria:
United States, Indiana | |
Indiana University, Department of Radiation Oncology | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Anna McDaniel, DNS, RN, FAAN | Department of Environments for Health, Indiana University School of Nursing |
Study ID Numbers: | 0508-12, Walther Cancer Institute, Inc |
Study First Received: | October 7, 2005 |
Last Updated: | October 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00236288 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
Cancer treatment and tobacco abuse |
Smoking Dopamine Mental Disorders Tobacco Use Disorder |
Bupropion Substance-Related Disorders Disorders of Environmental Origin |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |