A Feasibility Study of Smoking Cessation Program in Radiation Oncology
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Feasibility Study of Smoking Cessation Program in Radiation Oncology|
- To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic. [ Time Frame: 1 year from enrollment ]
- Smoking cessation status will be formally assessed by patient report, and for those reporting tobacco abstinence, confirmed by carbon monoxide breath testing concentrations of 10 ppm or less. [ Time Frame: 1 year from enrollment ]
|Study Start Date:||October 2005|
|Study Completion Date:||April 2007|
Drug: Bupropion and intensive behavioral therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236288
|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|